As filed with the Securities and Exchange Commission on September 27, 2024

File No. 000-_______

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10

GENERAL FORM FOR REGISTRATION OF SECURITIES

Pursuant to Section 12(b) or (g) of the Securities Exchange Act of 1934

Copies to:

Securities to be registered pursuant to Section 12(g) of the Act: None.

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act ☒

TABLE OF CONTENTS

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This registration statement on Form 10 of BioStem Technologies, Inc. (hereinafter the “Company,” “BioStem,” “BioStem Technologies,” “we,” “us” or “our”) contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. In this registration statement, forward-looking statements are generally identified by words such as “anticipate,” “plan,” “believe,” “expect,” “estimate” and the like. Forward-looking statements involve future risks and uncertainties, there are factors that could cause actual results or plans to differ materially from those expressed or implied. These statements are subject to known and unknown risks, uncertainties, and other factors that could cause the actual results to differ materially from those contemplated by the statements. The forward-looking information is based on various factors and is derived using numerous assumptions. A reader should not place undue reliance on these forward-looking statements, which apply only as of the date of this registration statement. Specifically, this registration statement contains forward-looking statements regarding:

These forward-looking statements reflect our current views about future events and are subject to risks, uncertainties and assumptions. We undertake no obligation to update forward-looking statements to reflect events or circumstances after the date hereof, unless otherwise required by law. We wish to caution readers that certain important factors may have affected and could in the future affect our actual results and could cause actual results to differ significantly from those expressed in any forward-looking statement. The most important factors that could prevent us from achieving our goals, and cause the assumptions underlying forward-looking statements and the actual results to differ materially from those expressed in or implied by those forward-looking statements include, but are not limited to, the following:

MARKET AND INDUSTRY DATA

Unless otherwise indicated, information contained in this Form 10 Registration Statement concerning our industry and the markets in which we operate is based on information from independent industry and research organizations, other third-party sources (including industry publications, surveys and forecasts) and management estimates. Management estimates are derived from publicly available information released by independent industry analysts and third-party sources, as well as data from our internal research, and are based on assumptions made by us upon reviewing such data and our knowledge of such industry and markets which we believe to be reasonable. Any industry forecasts are based on data (including third-party data), models and experience of various professionals and are based on various assumptions, all of which are subject to change without notice. Although we believe the data from these third-party sources are reliable as of their respective dates, we cannot provide any assumptions regarding the accuracy or completeness of this information. In addition, projections, assumptions and estimates of the future performance of the industry in which we operate, and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, including those described in “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements.” These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.

TRADEMARKS, SERVICE MARKS AND TRADE NAMES

We own or have rights to various trademarks, service marks and trade names that we use in connection with the operation of our business. This Form 10 Registration Statement may also contain trademarks, service marks and trade names of third parties, which are the property of their respective owners. Solely for convenience, our trademarks, service marks and trade names referred to in this Form 10 Registration Statement may appear without the ®, TM or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks, service marks and trade names.

Item 1. Business

Business Overview

We aim to be the leader in regenerative medicine focused on the development, manufacture, and commercialization of placental-derived allografts for advanced wound care. Our mission is to change patients’ lives for the better with the power of superior processes and an unwavering commitment to innovation, quality and superior outcomes.

Prior to 2018, our business was relating to research and development efforts primarily focused on the development of regenerative medicine products. Since 2018, upon our acquisition of Vera Life Sciences, LLC (“Vera”), our primary business became the development, manufacture, and distribution of tissue allografts for the advanced wound care market with a focus on diabetic ulcers, pressure ulcers and venous ulcers. We market and distribute products to medical professionals, such as podiatrists and plastic surgeons, indirectly through distributors and, to a much lesser extent, through direct and contract sales forces. Today, our products are comprised solely of placenta-derived allografts, which are human tissues that serve as a protective barrier or covering, but we intend to expand our portfolio of products across the continuum of advanced wound care.

Leveraging our proprietary BioREtain processing method, we manufacture perinatal tissue allografts at the highest quality level. BioREtain has been developed by applying the latest research in tissue processing technology, focused on preserving natural growth factors and tissue structure.

Our allografts, including AmnioWrap2, VENDAJE, VENDAJE AC and VENDAJE OPTIC, are trusted by top clinicians across a range of specialties. Our wound covering products have been shown through clinical and scientific studies to support tissue healing of chronic and hard-to-heal wounds and improve patient outcomes.

The quality of our allografts is essential to our success. Our lab is accredited by the American Association of Tissue Banks (“AATB”) and adheres to applicable U.S. Food and Drug Administration (“FDA”) standards. We strive to provide products and services which not only meet but exceed, Current Good Tissue Practices (“CGTP”) requirements. AmnioWrap2, VENDAJE, VENDAJE AC and VENDAJE OPTIC are perinatal tissue-derived allografts.

As of June 30, 2024, we had 32 full-time employees located primarily in Florida.

We had net income of $6,286,028 and $9,543,420 for the three and six months ended June 30, 2024, respectively, as compared to net losses of $2,855,026 and $6,435,114 for the three and six months ended June 30, 2023, respectively. We have an accumulated deficit of $36,080,697 and working capital surplus of $12,512,673 as of June 30, 2024. We incurred net losses of $8,482,984 and $7,231,796 for the years ended December 31, 2023 and 2022, respectively, and had an accumulated deficit and working capital deficit of $45,624,117 and $3,021,835, respectively, as of December 31, 2023.

We have applied to list our common stock on The Nasdaq Stock Market (“Nasdaq”) under the symbol “BSEM”. We cannot guarantee that we will be successful in listing our common stock on Nasdaq, and our common stock may continue to trade only on the Pink tier of the OTC Marketplace under the symbol “BSEM.”

History and Organization

We were incorporated on July 7, 2006 and have been operating as BioStem Technologies, Inc. since August 2014. On August 3, 2018, our wholly-owned operating subsidiary Blue Tech Industries, Inc., a Delaware corporation (d/b/a BioStem Life Sciences, Inc. or “BSLS”), acquired the assets of Vera. To fund the acquisition, BSLS issued 100 shares of common stock of BSLS, or 10% of the outstanding shares of BSLS, to a noncontrolling shareholder, in exchange for cash. Subsequent to this acquisition and through December 31, 2022, the shares held by the noncontrolling shareholder were reported as noncontrolling interest in our consolidated financial statements. Accordingly, prior to January 2023, we owned a controlling interest (90%) in BSLS. In January 2023, we repurchased the remaining 10% interest from the noncontrolling shareholder in exchange for 500,000 shares of common stock of the Company. In June 2024, we incorporated Auxocell Operations Inc (“Auxocell”), a new wholly-owned subsidiary of BioStem Technologies, Inc. Auxocell is domiciled in Nevada and holds certain intellectual property assets.

Our offices are located at 2836 Center Port Circle, Pompano Beach, FL 33064, and our telephone number is (954) 380-8342. Our website address is www.biostemtech.com and our email address is info@biostemtech.com. Information contained on, or accessible through, the foregoing website is not a part of, and is not incorporated by reference into, this Form 10 Registration Statement.

Industry Overview

We believe that the unmet need for healing solutions is large and growing, with a growing population of people suffering from chronic, non-healing wounds. The treatment of chronic wounds is often referred to as Advanced Wound Care (“AWC”). Chronic wounds are defined and characterized as those that do not progress through the normal process of healing and remain open for an extended period of time, which, depending on the wound, can be from several weeks to a few months. There are numerous underlying causes of these wounds, with this patient population typically sharing some combination of comorbidities, including age, obesity, smoking history, diabetes and heart and vascular diseases.

Patients present with chronic wounds in a variety of care settings and these wounds vary in severity and complexity to treat. Our products can be found in many of these sites of service, including the private physician office (e.g., podiatry clinics), wound care centers, hospital inpatient and outpatient settings, nursing homes and federal facilities, such as those operated by the Department of Veterans Affairs (“VA”). The most common types of chronic and hard-to-heal wounds appear in the lower extremities, presenting as diabetic foot ulcers (“DFUs”), venous leg ulcers (“VLUs”), and pressure ulcers, among others. According to GlobalData, taken together, nearly 70% of the chronic wounds in the U.S. are categorized as chronic leg ulcers (which include DFUs and VLUs), with 42% treated with AWC such as skin substitutes. These wounds require intervention and active management by clinicians and are treated in a variety of sites-of-service, with numerous products aimed at achieving healing for the patient. The costs associated with treatment and management of patients with acute and chronic wounds are also high, with some estimates of the Medicare spend associated with such wounds approaching $100 billion annually. According to the National Library of Medicine, Diabetic foot ulcers are a widespread and highly serious complication, impacting

around 15% percent of individuals with diabetes. Annually, over two million Americans in the U.S. develop diabetic foot ulcers, which are chronic wounds capable of resulting in amputation and, in severe cases, even the loss of a patient's life.

Due to the rising incidence of each of these factors, we expect that the AWC market will continue to grow. According to Allied Market Research, the global advanced wound care market size was valued at $10.3 billion in 2022, and is projected to reach $17.8 billion by 2032, growing at a CAGR of 5.6% from 2023 to 2032. The growth of the advanced wound care market is driven by a rise in adoption of evidence-based treatments for chronic wounds, wide availability of advanced therapy devices and rapid increase in the geriatric population. Moreover, the increase in prevalence of chronic diseases such as diabetes and obesity and rise in disposable income in developing economies fuel the adoption of advanced wound care therapies. For instance, according to the National Diabetes Statistics Report for 2022 by Centers for Disease Control and Prevention ("CDC"), in 2022, about 37.3 million people were estimated to suffer from diabetes in the U.S. As the number of people with diabetes continues to grow, so does the risk of developing diabetic foot ulcers, leading to higher demand for effective treatment options.

The prevalence of both acute and chronic wounds has grown not only in the U.S., but also globally. According to Grand View Research, the global wound care dressing market was valued at $14.2 billion in 2023 and is projected to grow at a CAGR of 4.16% from 2024 to 2030. The increasing prevalence of diverse wounds, including pressure ulcers and surgical site wounds, coupled with a growing aging population and a rise in traumatic accidents globally, is anticipated to drive the growth of the market.

The large and increasing number of patients requiring advanced treatment represents a significant cost burden on the healthcare system. According to the Alliance of Wound Care Stakeholders, the overall cost of treating chronic wounds is rising sharply, and the current annual estimated cost in the United States exceeds $28 billion.

According to the National Library of Medicine, complications from non-healing chronic wounds can ultimately result in significant, life-altering adverse outcomes, such as limb amputation. Ineffective wound management is linked to numerous poor outcomes for patients, up to and including the potential for amputation of the extremity where the wound is present. Amputation is a catastrophic event for patients, with significant impacts to their quality of life, the lives of their caretakers and the expense burden on the healthcare system. Today, up to one-fifth of diabetic patients who develop a DFU will require some form of amputation. Further, according to AHA Journals, patients who undergo a major lower extremity amputation have an increased five-year mortality rate that is comparable to, and in some cases higher than, patients with many forms of cancer.

The AWC market is comprised of many product types, such as medical devices, advanced dressings, xenografts, biological products, and Human Cells, Tissues, and Cellular and Tissue - Based Products (“HTC/Ps”), which are used as skin substitutes to treat severe and chronic wounds. Not included in AWC are traditional wound care dressings, such as bandages, gauzes and ointments, which typically are used in the treatment of non-severe or non-chronic wounds.

Traditional dressings such as bandages, gauzes and ointments, along with treatment of active infection and debridement, currently represent the “standard of care” for treating chronic wounds such as DFUs and VLUs. If, after four weeks of standard of care therapy, the wound has not responded appropriately or improved, clinical research has shown that advanced therapy such as a skin substitute can be beneficial as part of the patient’s treatment plan. However, oftentimes advanced therapies are not employed due to current treatment guidelines, product access, or medical education around the clinical and economic benefits of AWC products, including skin substitutes.

We believe these industry trends represent a large opportunity for us to drive initiatives to increase market penetration.

Our Strategy

We believe the following strategies will play a critical role in our future growth:

Competitive Strengths

We believe we have several unique strengths that have been instrumental to our success and position us well for future growth:

Our Technology and Products

Leveraging our proprietary BioREtain processing method, we manufacture perinatal tissue allografts at the highest level of quality. BioREtain has been developed by applying the latest research in regenerative medicine, focused on preserving natural growth factors and tissue structure. Our allografts, including AmnioWrap2, VENDAJE, VENDAJE AC and VENDAJE OPTIC are trusted by top clinicians across a range of specialties.

Technology

BioREtain

Historically, placental membrane processing has been primarily focused on the preservation of cells or removal of all non-solid matrix components. Since the development of these processes, scientific progress has been made uncovering the value of other factors within the placental tissue that are invaluable to wound healing. These factors do not rely on graft cellular content, hence preservation of cells is unnecessary. Additionally, removal of everything down to the solid matrix essentially depletes the grafts of the valuable factors endogenous to placental tissue. BioREtain is a proprietary tissue processing technology developed by BioStem to preserve the natural factors and tissue structure, the science of letting nature do its work. To provide safe, biocompatible, factor-rich grafts, we have developed a processing regime that cleans and prepares the tissues in a gentle and effective manner, while minimizing the risk involved in utilizing biologic tissue for implantation. This proprietary six-step process utilizes isotonic, hypothermic solutions with minimal disruption to ensure that the membrane structure and inherent factors are protected to the greatest extent. There are no harsh chemicals beyond initial disinfecting and no scraping or ablation of the natural components of the placental tissue. Additionally, no high heat or ice formation is used in dehydration, and grafts are individually packed and terminally sterilized via electron beam sterilization (E-beam). E-beam avoids harmful byproducts, excessive cross-linking of valuable factors and long irradiation times associated with other methods.

Examples of factors retained in BioREtain-processed placental tissue are IL-1ra, HGF, PDGF-BB, among others. According to a peer-reviewed scientific publication, when compared to competitor ablative methods, BioREtain results in a final product with higher levels of endogenous factors and stromal components. The factors set forth below are widely recognized across the industry and considered the most impactful due to their healing properties.

Sabol, et.al., Standardized Reporting of Amnion and Amnion/Chorion Allograft Data for Wound Care, Health Sci Rep. (Aug. 23, 2022).

Our Products

The use of amniotic membrane was initially limited due to storage challenges associated with use of fresh tissue. Modern processing methods – including dehydration – have delivered options that have longer shelf lives, can be stored at ambient temperatures, and can be terminally sterilized. Dehydrated human amniotic membrane (AM) is now widely used across clinical specialties as a covering for chronic wounds, burns, incisions and other treatment areas where a protective barrier is needed. The extracellular matrix (ECM) of amniotic membrane provides mechanical protection and support for endogenous tissue integration. The amniotic membrane forms the innermost layer of the human placenta and acts as a protective barrier for the developing fetus.

AmnioWrap2

AmnioWrap2 ("AmnioWrap2" or "AW2") is a full thickness structural tissue allograft composed of the amnion, intermediate and chorion layers of the placental membrane. AW2 is intended for homologous use as a protective covering for soft tissue wounds. AW2 is sterilized via e-beam irradiation and has a 4-year shelf life stored at ambient temperatures. AW2 allografts are available in a wide range of sizes and shapes for maximum versatility. AmnioWrap2 was launched in September 2023.

We have entered into an exclusive distribution and services arrangement with Venture Medical, LLC ("Venture Medical"), a large distributor located in the United States for the distribution of our AmnioWrap2 product. We license the right to manufacture and commercialize AmnioWrap2 from an unrelated party. Pursuant to this license agreement, we pay a per square centimeter licensing fee for all AmnioWrap2 product sold.

Unlike some other human dehydrated amnion/chorion products, AW2 also preserves the intermediate layer (IL) between the amnion and chorion. The IL has its own reserve of chemokines, growth factors and interleukins. We continue to further characterize these BioREtain-processed membranes, including additional growth factors and structural components. To date, the following have been evaluated within AW2 allografts:

Cytokines:

Extracellular matrix (ECM) components:

VENDAJE

VENDAJE is a structural tissue allograft composed of the amnion layer of the placental membrane processed using our proprietary BioREtain process. It is intended for homologous use as a protective covering for soft tissue wounds. VENDAJE is sterilized via e-beam irradiation and has a 5-year shelf life stored at ambient temperatures. VENDAJE allografts are available in a wide range of sizes and shapes for maximum versatility. VENDAJE was launched in July 2021.

A look inside VENDAJE®:

We continue to further characterize these BioREtain-processed membranes, including additional growth factors and structural components. To date, the following have been evaluated within VENDAJE allografts:

Cytokines:

Extracellular matrix (ECM) components:

VENDAJE AC

VENDAJE AC is a full thickness structural tissue allograft composed of the amnion, intermediate and chorion layers of the placental membrane. VENDAJE AC is intended for homologous use as a protective covering for soft tissue wounds. VENDAJE AC is sterilized via e-beam irradiation and has a 4-year shelf life stored at ambient temperatures. VENDAJE AC allografts are available in a wide range of sizes and shapes for maximum versatility. VENDAJE AC was acquired in 2018 and received a Q code in November 2023.

A look inside VENDAJE AC:

Unlike some other human dehydrated amnion/chorion products, VENDAJE AC also preserves the IL between the amnion and chorion. The IL has its own reserve of chemokines, growth factors and interleukins. We continue to further characterize these BioREtain-processed membranes, including additional growth factors and structural components. To date, the following have been evaluated within VENDAJE AC allografts:

Cytokines:

Extracellular matrix (ECM) components:

VENDAJE OPTIC

VENDAJE OPTIC is a structural tissue allograft composed of only the amnion layer of the placental membrane. This single layer of amnion measures between 20-50 microns thick, making VENDAJE OPTIC ideal for delicate ophthalmic applications. This is an ultra-thin, ultra-light human connective tissue allograft which is processed using our proprietary BioREtain process. VENDAJE OPTIC is intended for homologous use as a protective covering during the repair of ocular surfaces. This covering can be applied directly to the eye without the use of additional hardware or sutures. VENDAJE OPTIC is sterilized via e-beam irradiation and has a 4-year shelf life stored at ambient temperatures. VENDAJE OPTIC allografts are available in a range of sizes for maximum versatility. VENDAJE OPTIC was acquired in 2018.

We continue to further characterize these BioREtain-processed membranes, including additional growth factors and structural components. To date, the following have been evaluated within VENDAJE OPTIC:

Cytokines:

Extracellular matrix (ECM) components:

Placenta Donation Program

In order to obtain the source material for our placental-based product portfolio, we partner with several tissue acquisition agencies to recover donations of these materials around the United States. Through these agencies, a mother who delivers a healthy baby can donate her placenta and umbilical cord tissue in lieu of having it discarded as medical waste. After consent for donation is obtained, a blood sample from each donor is tested for communicable diseases, and the donor is screened for risk factors in order to determine eligibility in compliance with federal regulations and AATB standards. We operate a licensed tissue bank that is registered as a tissue establishment with the FDA, and we are an accredited member of the AATB. All donor records and test results are reviewed by our Medical Director and staff prior to the release of the tissue for distribution to ensure that each donor tissue is determined to be eligible for transplantation.

We utilize geographically diverse tissue acquisition agencies across the United States to ensure adequate supply of materials needed to meet customer demand. We believe that we will be able to obtain an adequate supply of tissue to meet anticipated demand for the foreseeable future.

Customers

Our customers consist of medical professionals, such as podiatrists and plastic surgeons. A high concentration of our revenue comes from a limited number of customers. Accordingly, in each year there may be a small number of customers from whom we generate our revenue. These customers may not be repeat purchasers and in each year it may be a different single purchaser or small number of purchasers from which we generate a large percentage of our revenues. We rely on these purchasers and there is a risk that these purchasers may be unable to make payment under their obligations to us, thereby affecting our revenues.

One customer, Venture Medical, accounted for approximately 98% of accounts receivable as of December 31, 2023. Three customers accounted for approximately 81% of accounts receivable as of December 31, 2022. For the year ended December 31, 2023, we generated approximately 82% of consolidated net revenue from one customer, Venture Medical. For the year ended December 31, 2022, we generated approximately 30% of consolidated net revenue from one customer, Radiant Health Solutions.

Reimbursement

Currently, most purchasers of our products are medical professionals, such as podiatrists that rely on reimbursement by third-party payers. Accordingly, our growth substantially depends on adequate levels of third-party reimbursement for our products from these payers. Third-party payers are sensitive to the cost of products and services and are increasingly seeking to implement cost containment measures to control, restrict access to, or influence the purchase of health care products and services. In the U.S., such payers include U.S. federal healthcare programs (e.g., Medicare and Medicaid), private insurance plans, managed care programs, and workers’ compensation plans. Federal healthcare programs have prescribed coverage criteria and payment rates for medical products, services, and procedures. Similarly, private, third-party payers have their own coverage criteria and negotiate payment amounts for medical products, services, and procedures with providers. In addition, in the U.S., an increasing percentage of insured individuals are receiving their medical care through managed care programs (including managed federal healthcare programs) which monitor and may require pre-approval of the products and services that a member receives. Ultimately, however, each third-party payer determines whether and on what conditions they will provide coverage for our products, and such decisions often include each payer’s assessment of the science and efficacy of the applicable product.

A portion of our products is purchased directly by U.S. government accounts (e.g., the VA and the Public Health Service), which do not depend on reimbursement from third-party payers. In order for us to have our products purchased by such federal agencies, we participate in the VA Federal Supply Schedule (“FSS”) pricing program.

Medicare and Medicaid

The Centers for Medicare and Medicaid Services (“CMS”) within the U.S. Department of Health and Human Services (“HHS”) administers the Medicare and Medicaid programs. Title XVIII of the Social Security Act establishes the Medicare program to pay for the costs of certain healthcare services and items for eligible individuals. Eligibility for Medicare is based on age, disability or diagnosis of End-Stage Renal Disease. CMS has established guidelines for the Medicare coverage and payment of certain items and services. Generally, to be reimbursed by Medicare, a healthcare item or service furnished to a Medicare beneficiary must be reasonable and necessary for the diagnosis or treatment of an illness or injury, or to improve the functioning of a malformed body part. The methodology for determining coverage status and the amount of Medicare payment varies based upon, among other factors, the setting in which a Medicare beneficiary received healthcare items and services. Any changes in federal legislation, regulations and policy affecting CMS coverage and payment relative to any procedure using our products could have a material effect on our business.

Title XIX of the Social Security Act establishes the Medicaid program, which is a system of medical assistance for families with dependent children and for aged, blind and disabled individuals who are below certain income thresholds. Though federally created, the Medicaid program is a joint federal-state program. CMS administers the federal portion of the Medicaid program with states establishing additional coverage and payment regulations. Changes to the availability of coverage, method or level of payment for relevant services using our products may have a material effect on our business. The Medicare and Medicaid programs are subject to statutory and regulatory changes, retroactive and prospective rate adjustments, administrative rulings, interpretations of policy, intermediary determinations and government funding restrictions, all of which may materially increase or decrease the rate of program payments to healthcare providers and suppliers who purchase our products.

The reimbursement framework for products under Medicare is determined in accordance with the Social Security Act and pursuant to regulations promulgated by CMS, as well as the agency’s coverage and payment guidance. In some cases, CMS does not specify coverage, leaving each of the local Medicare Administrative Contractors (“MACs”) to determine whether and on what conditions Medicare will provide coverage for the product. Such decisions are based on each MAC’s assessments of the science and efficacy of the applicable product. As of the date of this Form 10 Registration Statement, VENDAJE, VENDAJE AC and AMNIOWRAP2 are eligible for coverage by all MACs. VENDAJE (Q4252), VENDAJE AC (Q4279) and AMNIOWRAP2 (Q4221) also received separate CMS HCPCS Codes, distinguishing each product in coverage and payment policies.

In August 2023, three MACs published changes to their Local Coverage Determinations (“LCDs”) that were intended to becoming effective on October 1, 2023, before ultimately being retracted. These LCDs listed those skin substitute products which would explicitly be eligible for coverage and those which would not. The LCDs also included language that would have lowered the number of allowed applications of a product below what is commonly used in standard practice by physicians today (supported by clinical evidence) and reflected by LCDs currently in force with the MACs. While these LCDs ultimately were not implemented, the MACs have indicated plans to bring forth a new proposed LCD for skin substitutes in the future, which could include elements that could be unfavorable to our business.

On April 25, 2024, all seven MACs (covering all twelve MAC jurisdictions in the U.S.) released identical proposed LCDs which are very similar to the August 2023 LCDs that were retracted. The proposed LCDs include language that would lower the number of allowed applications of a skin substitute product, and also would require published, peer-reviewed evidence to support coverage of skin substitute products. As proposed, the LCDs would eliminate Medicare coverage for our products absent the development of acceptable published, peer-reviewed evidence. Currently, management cannot determine the timing of when, if any, decision will be made on the proposed LCDs.

In the physician office setting, providers that administer allografts and other skin substitutes are currently separately reimbursed for the skin substitute product based on the size of the graft, computed on a per square centimeter basis. The payment rate for many skin

substitute products is calculated using the manufacturer’s reported average sales price (“ASP”) submitted quarterly to CMS, and is updated on a quarterly basis. CMS includes these payment rates (established by statute at ASP + 6%) on the Medicare national ASP Drug Pricing File. AMNIOWRAP2, VENDAJE, VENDAJE AC and VENDAJE OPTIC are included on the Medicare national ASP Drug Pricing File. Reimbursement for products not included on the Medicare national ASP Drug Pricing File are at the discretion of each MAC, which is based on invoice or wholesale acquisition cost (“WAC”) plus an add-on percentage. The physician office payment methodology also applies to other places of service where the skin substitute product is administered by a health care professional, including patient home, assisted living facility and nursing home.

In 2022, CMS announced plans to potentially change the payment methodology for skin substitutes in the physician office setting but did not finalize any changes to the payment methodology for these products. In March 2023, the HHS Office of Inspector General published a report entitled, “Some Skin Substitute Manufacturers Did Not Comply with New ASP Reporting Requirements,” which detailed problematic expenditure issues associated with the current Medicare reimbursement landscape in the physician office setting for some skin substitute products. In alignment with many industry stakeholders, the report recommended that all skin substitute products transition to ASP-based payments as soon as possible in an effort to substantially reduce Medicare expenditures for these products. Over the last several quarters, there has been a notable increase in the number of skin substitute products listed on the Medicare national ASP Drug Pricing File, but non-ASP or WAC-based products still remain available in the marketplace.

In the hospital setting, facilities are paid for skin substitutes based on a packaged or bundled payment methodology for the entire procedure performed or entire hospital stay. There is no separate payment for the skin substitute product. Thus, in such instances, we educate hospitals about the cost-effectiveness of our products and their potential to enhance patient outcomes and shorten hospital stays. Our ongoing efforts include generative further health economic data to reinforce this message. The sale of products for use in a hospital setting depends on effectively demonstrating their clinical efficacy and cost efficiency to the hospital administration.

In September 2023, we were successfully listed on key government contract vehicles, on the Department of Defense’s Distribution and Pricing Agreement (“DAPA”), the FSS, and the Defense Logistics Agency’s ECAT system. This listing was made possible by BioStem’s Service-Disabled Veteran-Owned Small Business (“SDVOSB”) exclusive partner.

Private Payers

We have begun to devote considerable resources to clinical trials to support reimbursement of our products with the goal of increasing the number of private payers who will reimburse for our products in the physician office. Coverage and payment will vary according to the patient’s health plan and related benefits.

Sales and Marketing

We market and distribute products to medical professionals, such as podiatrists and plastic surgeons, indirectly through distributors and, to a much lesser extent, through direct and contract salesforces.

We primarily sell our products indirectly through distributors. Distributors purchase products from us at wholesale acquisition cost and resell products to providers and end users, and we pay these distributors for the services they provide on our behalf.

We also sell our products through direct and contract salesforces. Our direct sales team includes field sales representatives and field sales management, who call on hospitals, wound care clinics, physician offices, emergency rooms and other health care facilities. Our direct sales force primarily focuses on the advanced wound care categories through multiple sites of service.

Distribution and Services Agreement

On September 8, 2023, we entered into a distribution and services agreement (the “Distribution Agreement”) with Venture Medical, LLC, a large medical distributor located in the United States (the “Distributor”) for the distribution of our AmnioWrap2 product. We license the rights to manufacture and commercialize AW2 from an unrelated party and in conjunction with the licensing arrangement, we pay a license fee based on square centimeters for all AW2 products sold by the Distributor. The Distributor purchases the AW2 products from us at a fixed fee per square centimeter (“Sales Price”) with no right of return. Separately, the Distributor invoices us monthly for distinct sales, marketing and distribution services it provides on our behalf (“Bona Fide Services Fee” or “BFSF”). These services also include, among other things, insurance coverage and eligibility, claims processing, quality assurance, inventory management and returns, and other day-to-day operations services. The BFSF is consideration payable to the Distributor for the distinct services the Distributor is providing to us.

The term of the Distribution Agreement is three years from the date of entry, with automatic renewals for successive one-year terms, unless either party gives notice to the other party of its intent not to renew the Distribution Agreement no less than 90 days prior to the expiration of the applicable term. If either party gives notice to the other party of its intent not to renew, the Distributor will use good faith efforts to minimize its inventory of AW2 remaining at the effective date of the termination.

Pursuant to the Distribution Agreement, the Distributor is obligated to purchase a minimum amount of AW2 products each calendar quarter during the term. In addition to customary termination provisions, we may terminate the Distribution Agreement upon giving 90 days’ notice if the Distributor does not purchase the minimum purchase amount during two consecutive calendar quarters and the Distributor may terminate the Distribution Agreement upon giving one year’s written notice for the convenience of the Distributor. Upon termination of the Distribution Agreement, provided that Distributor has complied with its obligations to minimize inventory, we will purchase from Distributor all of the AW2 held by the Distributor which are in good and saleable condition at the price that the Distributor paid to us less any discounts and allowances. At our option, we may fulfill or refund any stocking orders placed but not shipped.

On March 1, 2024, we entered into an amendment (the "Distribution Agreement Amendment") to the Distribution Agreement to increase the minimum calendar quarterly volume commitment and increase the BFSF.

Intellectual Property

Our intellectual property includes owned and licensed patents, owned and licensed patent applications and patents pending, proprietary manufacturing processes and trade secrets, and trademarks associated with our technology. We believe that our patents, proprietary manufacturing processes, trade secrets, trademarks, and technology licensing rights provide us with important competitive advantages.

Patents

The following tables summarize our held and applied for patents together with their duration.

Exclusive Commercialization and IP Agreement

On June 29, 2023, we entered into an Exclusive Commercialization and IP Agreement (the “License Agreement”) with Hesed Life and Medical LLC, a California Limited Liability Company ("Hesed"), pursuant to which we license the rights to manufacture and commercialize AmnioWrap2 from Hesed, which is an unrelated party using our BioREtain technology which we licensed to Hesed for that purpose. Pursuant to the License Agreement, we pay a license fee based on square centimeters for all AW2 product sold. The initial term of the License Agreement is for one year with automatic one-year renewals unless written notice of non-renewal for any reason is given by either party at least 90 calendar days prior to the expiration of the applicable term. After the 180-day period following termination, Hesed will have the option to purchase the remaining inventory of AmnioWrap2 in our possession and if Hesed chooses not to exercise this option, we will be permitted to continue to sell the remaining AmnioWrap2 until it is sold out. The License Agreement contains customary confidentiality and non-disclosure provisions for agreements of this type.

Competition

We operate in highly competitive markets that are subject to rapid technological change. Success in these markets depends primarily on product efficacy, ease of product use, product price, availability of coverage and adequate third-party reimbursement, customer support services for technical, clinical and reimbursement support, and customer preference for, and loyalty to, the products.

Our products compete primarily with skin substitute products, amniotic technology products, orthobiologics products, other advanced wound care and traditional wound care products, among others. Our principal competitors include Integra LifeSciences Holdings Corporation, MiMedx Group, Inc., Organogenesis Inc., Smith & Nephew plc, and Bioventus Inc.

We also compete in the marketplace to recruit and retain qualified scientific, management and sales personnel, as well as to acquire technologies and technology licenses complementary to our products or advantageous to our business. We are aware of several companies that compete, or are developing technologies, in our current and future product areas. As a result, we expect competition to remain intense. Our ability to compete successfully will depend on our ability to develop proprietary products that reach the market in a timely manner, receive adequate coverage and reimbursement, are cost effective and are safe and effective.

Government Regulation

We are subject to extensive and ongoing regulation by the FDA under Section 361 of the Public Health Service Act (“PHSA”) and FDA’s implementing regulations, as well as other federal and state regulatory bodies in the United States. These laws and regulations govern, among other things, product design and development, pre-clinical and clinical testing, manufacturing, processing, packaging, labeling, storage, record keeping and reporting, marketing, distribution, promotion, import and export, and post-marketing surveillance.

Unless an exemption applies, each establishment that manufactures a human cell, tissue, and cellular and tissue-based product (“HCT/P”) under Section 361 of the PHSA (“Section 361 HCT/P”) must register with the FDA and list all HCT/Ps with the FDA. The development, manufacturing, and marketing of HCT/Ps can be resource intensive, expensive, and lengthy, as well as require payment of significant fees, unless an exemption is available.

We do not currently sell any cellular and tissue-based products considered to be drugs, devices, and/or biological products subject to licensure under Section 351 of the Public Health Service Act or approval or clearance under the Federal Food, Drug, and Cosmetic Act (“FDCA”) and related regulations. HCT/Ps that are not solely Section 361 HCT/Ps are regulated as biological products, drugs, and/or devices, and, in order to be lawfully marketed in the United States, require FDA pre-market licensure, approval, or clearance. As discussed above, the products in our portfolio are currently regulated as Section 361 HCT/Ps. However, we may in the future decide to offer new products that would constitute, or qualify as, medical devices, drugs, and/or biologics, which would require compliance with more stringent FDA regulatory requirements, including a Biologics License Application, New Drug Application, or medical device Premarket Approval or 510(k) clearance.

Tissue Products

In 1997, the FDA proposed a regulatory framework for products deriving from cells and tissues from the human body. This framework was intended to provide adequate protection of public health by providing regulatory oversight over the development of new therapies and products using HCT/Ps. To qualify as a Section 361 HCT/P under the current regulatory framework, an HCT/P generally must meet all four of the following criteria:

Certain amniotic and other birth tissues are considered cellular and tissue-based articles and are therefore eligible for regulation solely as a Section 361 HCT/P depending on whether the specific product at issue and the claims made for it are consistent with the criteria set forth above. HCT/Ps that do not meet these criteria may be subject to more extensive regulation as drugs, medical devices, biological products, or combination products.

Products Regulated Solely as HCT/Ps under Section 361 of the PHSA

Currently, our products are categorized as Section 361 HCT/Ps. The FDA has specific regulations governing HCT/Ps, including those regulations set forth in 21 CFR Part 1271. Unless an exception applies, all establishments that manufacture Section 361 HCT/Ps must register and list their HCT/Ps with the FDA within five days after commencing operations. All HCT/Ps that an establishment processes, stores, labels, packages, distributes, or for which the establishment began donor screening or testing, must be listed with the FDA. In addition, establishments are required to update their registration annually in December or within 30 days of certain changes to the establishment. Any changes to the listed Section 361 HCT/Ps must be reported to the FDA at either the time of the change or each June or December, whichever is earlier.

After registering an establishment and listing HCT/Ps with the FDA, numerous and pervasive regulatory requirements continue to apply, such as donor screening, eligibility and testing requirements and Current Good Tissue Practices (“CGTP”) to prevent the introduction, transmission and spread of communicable diseases. An HCT/P must not be implanted, transplanted, infused, or transferred until the donor has been determined to be eligible, unless an exception applies. Eligible donors are those that are free from risk factors for, and clinical evidence of, infection due to relevant communicable diseases, as well as free from communicable disease risks associated with xenotransplantation, and, unless exempt, whose results of donor testing for relevant communicable disease agents are negative or nonreactive. Each Section 361 HCT/P establishment must establish and maintain procedures for all steps in testing, screening, determining donor eligibility, and complying with all other FDA requirements. Upon determining donor-eligibility, we must maintain records verifying donor-eligibility for each derived HCT/P and retain such records for 10 years after the date of administration of the derived HCT/P or, if that date is not known, after the date of the HCT/P’s distribution, disposition, or expiration, whichever is latest.

The CGTP govern, as may be applicable, the facilities, equipment, supplies, reagents, controls, and methods used in the manufacture of all HCT/Ps, including processing, storage, recovery, labeling, packaging, and distribution of Section 361 HCT/Ps. CGTP require us, among other things, to maintain a quality program for manufacturing and tracking HCT/Ps, train personnel, control and monitor environmental conditions as appropriate, control and validate processes, properly store, handle and test our products and raw materials, maintain our facilities and equipment, keep records and comply with standards regarding recovery, pre-distribution, distribution, tracking and labeling of our products, and complaint handling. Failure to maintain compliance with CGTP requirements could result in the shut down of, or restrictions on, manufacturing operations and the recall or seizure of products, which would harm our business.

The FDA may conduct periodic inspections of HCT/P manufacturing facilities, and contract manufacturers’ facilities, to assess compliance with CGTP and other requirements. Such inspections can occur at any time, with or without written notice, at such frequency as determined by the FDA in its sole discretion. To determine compliance with the applicable provisions, the inspection may include, but is not limited to, an assessment of the establishment’s facilities, equipment, finished and unfinished materials, containers, processes, HCT/Ps, procedures, labeling, records, files, papers and controls. If the FDA were to find serious non-compliant manufacturing or processing practices during such an inspection, it could take regulatory actions that could adversely affect our business, results of operations, financial condition, and cash flows.

The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that we failed to comply with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which could materially adversely affect our business such as:

In addition, a prolonged interruption in the manufacturing of one or more of our products as a result of non-compliance could decrease our supply of products available for sale, which could reduce our net sales, gross profits and market share, as well as harm our overall business, prospects, financial condition and results of operations.

Advertising and promotion of HCT/Ps, in addition to being regulated by the FDA, are also regulated by the Federal Trade Commission (“FTC”) and by state regulatory and enforcement authorities. Recently, promotional activities for FDA-regulated products have also been the subject of enforcement actions brought under healthcare reimbursement laws and consumer protection statutes. Competitors and others can also initiate litigation relating to advertising and promotional claims under the federal Lanham Act and similar state laws. In general, if the FDA determines that our promotional materials, which may include our product training, constitutes promotion of a non-homologous use that causes our product(s) to be non-Section 361 HCT/Ps, then it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our promotional or training materials to constitute promotion of an unauthorized use, to be inadequately substantiated, or to be otherwise false or misleading, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement.

Tissue Bank Laws, Regulations, and Related Accreditation

Procurement of certain human organs and tissue for transplantation is subject to various federal and state requirements, such as the National Organ Transplant Act (“NOTA”), which prohibits the transfer of certain human organs, including skin and related tissue, for valuable consideration, but permits the reimbursement of reasonable expenses associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of donated human tissue and skin. We reimburse tissue banks, hospitals, and physicians for their services associated with the recovery and storage of donated human tissue. If we are found to have violated NOTA, we may be subject to civil fines or criminal sanction.

In addition to federal requirements, certain states, including a number in which we commercialize products, require HCT/P establishments to obtain licenses granted by the health authorities of their respective states. We are licensed to operate in the following states: New York, Delaware, Illinois, Oregon, and Maryland. To the extent we would need a license or other similar approval to operate or expand our operations, our operations could be adversely affected by the inability to obtain the necessary licenses or approvals, changes in the standards applicable to those licenses or approvals, and possible delays and expenses associated with obtaining licenses or approvals.

The AATB is a nationwide organization that establishes standards relating to tissue banking and associated products. AATB standards include specific requirements for recovery, screening, testing, labeling, processing, and storing of birth tissue. Generally, AATB accreditation is voluntary. However, some state regulatory bodies and managed care organizations use AATB accreditation as a credentialing or licensing standard. We have obtained AATB accreditation, have undergone a corporate survey, and undergo continuous audits by the AATB to maintain our accreditation..

Federal and State Fraud and Abuse Laws

The federal and state governments have enacted, and actively enforce, a number of laws to address fraud and abuse in federal healthcare programs, including any healthcare plans or programs that are funded, in whole or in part, by the United States government (other than certain federal employee health insurance benefits/programs), such as Medicare and the Veterans Affairs program, and certain state healthcare programs that receive federal funds, such as Medicaid. Our business is subject to compliance with these laws.

Our operations are subject to various federal anti-fraud and abuse laws, including without limitation the federal Anti-Kickback Statute (“AKS”). The AKS is a criminal law that prohibits, among other things, any person from knowingly and willfully offering, soliciting, receiving or providing any remuneration (including any kickback, bribe or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward referrals, purchases or orders, or arranging for or recommending the purchase, order or referral of any item or service for which payment may be made in whole or in part by a federal healthcare program. The term “remuneration” has been broadly interpreted to include anything of value, whether in cash or in kind. The Patient Protection and Affordable Care Act amended the intent requirement of the federal AKS, so that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it. Although the AKS contains a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy all elements of an available exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the federal Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all its facts and circumstances. Almost any interaction wherein benefits of any value flow to a healthcare provider, patient, customer, or other source for the referral of business may implicate the federal Anti-Kickback Statute. A conviction for violation of the AKS may result in criminal and/or civil fines, potential

incarceration for individuals, and requires mandatory exclusion from participation in federal health care programs. Due to the breadth of the AKS, the narrowness of statutory exceptions and regulatory safe harbors available, and the range of interpretations to which they are subject, it is possible that some of our current or future practices might be challenged under one or more of these laws.

The Civil Monetary Penalty Act of 1981 (“CMP Act”) imposes civil penalties against any person or entity that, among other things, is determined to have presented or caused to be presented a claim to a federal healthcare program that the person knows or should know is for an item or service that was not provided as claimed or is false or fraudulent. The CMP Act also provides civil penalties for violations of the AKS, as well as including a specific provision prohibiting the offering or transferring of remuneration to a federal healthcare program beneficiary that a person knows or should know is likely to influence the beneficiary’s decision to order or receive items or services reimbursable by the government from a particular provider or supplier. In addition to the imposition of civil penalties, the Office of Inspector General of the Department of Health and Human Services (“OIG”) has the authority to determine on a case-by-case basis whether violations of the CMP Act should result in exclusion from participation in federal healthcare programs.

In addition to these federal laws, many states have similar fraud and abuse laws that typically apply to arrangements involving reimbursement by a state-funded Medicaid or other healthcare programs, but that may also apply more broadly to any healthcare products or services, including those reimbursed by private insurance or even by cash payment. Other state laws prohibit certain direct or indirect payments or fee-splitting arrangements between healthcare providers and other persons and entities, especially where they are designed to obtain or induce the referral of patients from a particular person or provider. Often, these laws closely follow the language of their federal law counterparts, although they do not always have the same exceptions or safe harbors.

Another key federal healthcare law is the federal healthcare fraud statute, which was added by the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). HIPAA created two new federal crimes: healthcare fraud and false statements relating to healthcare matters. The HIPAA healthcare fraud statute prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private payors. A violation of this statute is a felony and may result in fines, imprisonment and/or exclusion from government-sponsored programs. The HIPAA false statements statute prohibits, among other things, knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement or representation in connection with the delivery of or payment for healthcare benefits, items or services. A violation of this statute is a felony, which requires exclusion from participation in federal healthcare programs, and may result in substantial fines and/or imprisonment. Similar to the AKS, a person or entity does not need to have actual knowledge of the statutes or specific intent to violate them in order to have committed a violation.

Federal law also includes a provision commonly known as the “Stark Law,” which generally (i) prohibits physicians from making referrals for designated health services to entities in which the physicians have a direct or indirect financial relationship, and (ii) prohibits entities from presenting or causing to be presented claims or bills to any individual, third party payer, or other entity for designated health services furnished pursuant to a prohibited referral, unless permitted under a statutory or regulatory exception. Violations of the Stark Law may result in significant civil sanctions, including civil monetary penalties, denial of payment, refunds of amounts collected in violation of the Stark Law and exclusion from Medicare programs.

Federal False Claims Act

The federal False Claims Act (“FCA”) imposes civil liability on any person or entity that knowingly presents, or causes to be presented (including by a third party), a claim for payment to the U.S. government, including the Medicare and Medicaid programs, that is false or fraudulent, or which contains false information. In addition, any person or entity who knowingly makes or uses a false record or statement to avoid paying the federal government, or knowingly conceals or avoids an obligation to pay money to the federal government, may also be subject to fines under the FCA.

The federal government has used the FCA in connection with Medicare, Medicaid and other governmental program fraud in areas such as violations of the AKS or the Stark Law, coding errors, billing for services not provided and submitting false claims for reimbursement. The FCA has also been used to bring suit against people or entities that bill services at a higher reimbursement rate than is allowed and that bill for care that is not medically necessary. In addition to government enforcement, the FCA authorizes private citizens to bring qui tam or “whistleblower” lawsuits, greatly extending the number of actions under the FCA. Both because whistleblowers may receive up to thirty percent (30%) of the government’s recovery in an FCA matter and due to additional government incentives for whistleblowers to come forward, FCA whistleblower actions drive much of the federal government’s fraud recoveries from the healthcare and life sciences industry. As of 2024, the per-claim civil penalty range was between $13,946 and $27,894; however, the FCA also allows for the government to recover up to three times the amount that was reimbursed by federal health care programs pursuant to each false claim.

In the Patient Protection and Affordable Care Act and the Healthcare Education and Reconciliation Act (collectively, “ACA”), Congress enacted requirements related to identifying and returning overpayments made under Medicare and Medicaid. CMS finalized regulations regarding the so-called “60-day rule,” which requires persons and entities to report and return Medicare and Medicaid overpayments within 60 days of identifying the same. A person or entity who retains identified overpayments beyond 60 days may be liable under the FCA. “Identification” occurs when a person or entity “has, or should have through the exercise of reasonable diligence,” identified

and quantified the amount of an overpayment. The final rule also established a six-year lookback period, meaning overpayments must be reported and returned if a person or entity identifies the overpayment within six years of the date the overpayment was received. Persons and entities must report and return overpayments even if they did not cause the overpayment. In addition to the FCA, the federal government may use several criminal statutes to prosecute the submission of false or fraudulent claims for payment to the federal government. Many states have similar false claims statutes that impose liability for the types of acts prohibited by the FCA. As part of the Deficit Reduction Act of 2005 (“DRA”), Congress provided states an incentive to adopt state false claims acts consistent with the federal FCA.

Federal and State Privacy and Security Laws

We may be subject to data privacy and security regulation by both the federal government and the states in which we conduct our business. HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act (“HITECH”) and its implementing regulations, imposes certain requirements relating to the privacy, security and transmission of protected health information (“PHI”). Among other things, HITECH made HIPAA’s privacy and security standards directly applicable to “business associates,” independent contractors or agents of covered entities that receive or obtain protected health information in connection with providing a service on behalf of a covered entity.

HIPAA transaction regulations establish form, format and data content requirements for most electronic healthcare transactions, such as healthcare claims that are submitted electronically. The HIPAA privacy regulations establish comprehensive requirements relating to the use and disclosure of PHI. The HIPAA security regulations establish minimum standards for the protection of PHI that is stored or transmitted electronically. The HIPAA breach notification regulations establish the applicable requirements for notifying individuals, HHS, and the media in the event of a data breach affecting PHI. Violations of the privacy, security and breach notification regulations are punishable by civil and criminal penalties.

The American Recovery and Economic Reinvestment Act of 2009 (“ARRA”) increased the amount of civil monetary penalties that can be imposed for violations of HIPAA, and the amounts are updated annually for inflation. The current penalties for HIPAA violations can range from $137 to $2,067,813 per violation, with a maximum fine of $2,067,813 for identical violations during a calendar year. ARRA also authorized state attorneys general to bring civil enforcement actions under HIPAA, and attorneys general are actively engaged in enforcement. These penalties could be in addition to other penalties assessed by a state for a breach that would be considered reportable under the state’s data breach notification laws.

In addition to HIPAA, most states also have laws that protect the confidentiality of health information and other personal data. Certain of these laws grant individual rights with respect to their information, and we may be required to expend significant resources to comply with these laws. Furthermore, all 50 states and the District of Columbia have adopted data breach notification laws that impose, in varying degrees, an obligation to notify affected persons and/or state regulators in the event of a data breach or compromise, including when their personal information has or may have been accessed by an unauthorized person. Some state breach notification laws may also impose physical and electronic security requirements regarding the safeguarding of personal information, such as social security numbers and bank and credit card account numbers. Violation of state privacy, security, and breach notification laws can trigger significant monetary penalties. In addition, certain states’ privacy, security, and data breach laws, including, for example, the California Consumer Privacy Act, include a private right of action that may expose us to private litigation regarding our privacy practices and significant damages awards or settlements in civil litigation.

Even when HIPAA does not apply, according to the FTC, failing to take appropriate steps to keep consumers’ personal information secure may constitute unfair acts or practices in or affecting commerce in violation of Section 5(a) of the Federal Trade Commission Act, 15 U.S.C § 45(a). The FTC expects a company’s data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities. Individually identifiable health information is considered sensitive data that merits stronger safeguards. The FTC’s guidance for appropriately securing consumers’ personal information is similar to what is required by the HIPAA security regulations.

Physician Payments Sunshine Act

The federal Physician Payments Sunshine Act created the Open Payments Program requiring certain manufacturers of drugs, medical devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program to report annually to CMS information related to payments and other “transfers of value” to physicians and teaching hospitals. Additionally, applicable manufacturers must report annually ownership and investment interests held by physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, certified nurse-midwives, and their immediate family members. Failure to submit timely, accurate and complete reports may result in civil monetary penalties of up to $1 million per year.

While manufacturers of human cell and tissue products regulated solely under Section 361 of the PHSA are not subject to the federal Physician Payments Sunshine Act and its implementing regulations (together with the Act, the “Sunshine Act”), in the future, if we manufacture products beyond those regulated solely under Section 361, this law will require us (with certain exceptions) to report

information to CMS related to certain payments or other transfers of value we make to teaching hospitals, physicians, physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, certified nurse-midwives, and their family members. Such information will subsequently be made publicly available by CMS on the Open Payments website. There is a risk that CMS or another government agency may take the position that our products are not human cell and tissue products regulated solely under Section 361, and thereby assert that we are currently subject to the Sunshine Act, which could subject us to civil penalties and the administrative burden of having to comply with the law.

Additionally, similar reporting requirements have also been enacted in several states. In particular, a number of states have enacted laws that require certain manufacturers to monitor and report payments, gifts and other remuneration made to physicians and other healthcare providers, and, in some states, marketing expenditures. In addition, some state statutes impose outright bans on certain manufacturer gifts to physicians or other healthcare professionals. Some of these laws, referred to as “aggregate spend” or “gift” laws, carry various fines and penalties if they are violated.

Additional Regulations

Federal conflicts of interest laws, the Standards of Ethical Conduct for Employees of the Executive Branch, and local site policies for each federal institution we call upon govern our interactions with federal employees at our various government accounts (e.g., DoD, VA, etc.) and impose a number of limitations on such interactions.

*These are intended to be extended prior to expiration and we are in the process of obtaining the extensions.

Clinical Research and Development

Research and development costs include personnel costs for our research and development personnel, clinical study costs, expenses related to improvements to the manufacturing process, enhancements to our currently available products, and additional investments in the product and platform development pipeline. We expense research and development costs as incurred. Research and development costs were $341,996 and $224,775 for the years ended December 31, 2023 and 2022, respectively, as presented on the consolidated statements of operations. Our research and development expenses for the three and six months ended June 30, 2024, were $85,154 and $155,901 as compared to $60,904 and $130,632 for the three and six months ended June 30, 2023, respectively.

In October 2023, we announced the opening of the first clinical site for a study that will evaluate our VENDAJE tissue allograft in the treatment of diabetic foot ulcers ("DFU").

In April 2024, we retained the services of McCoy Clinical Consulting, LLC, which will lead BioStem’s Diabetic Foot Ulcer ("DFU") and Venous Leg Ulcer ("VLU") clinical trials process as a consultant. These studies are expected to begin in October 2024 for the DFU study and in December 2024 for the VLU study.

Environmental, Social & Governance Matters

Environmental Matters

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment, manufacture and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials or other work-related injuries, this insurance may not provide adequate coverage against potential liabilities. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Employees

As of June 30, 2024, we had 32 full-time employees and no part-time employees. Generally, we consider our relationships with our employees to be good, and none of our employees are covered by a collective bargaining agreement.

Our Diversity and Inclusion

We value the diversity of perspective, experience, and background. We have stated goals to promote diversity, inclusion, and equal opportunity regardless of race, gender, nationality, ethnic origin, religion, age, or sexual orientation. Intimidation or harassment of any kind are not acceptable in our workplace.

Our business requires a workforce with a wide range backgrounds, experiences, skills, and knowledge and a culture that blends this diversity into an effective team. In order for our employees to do their best work, and for us to achieve our mission, everyone must feel respected, valued, and included.

Available Information

Once this Form 10 Registration Statement is effective, we will be required to file proxy statements, annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K with the SEC. The SEC maintains an internet site, www.sec.gov, where these reports are available free of charge. We will also make these reports available free of charge on our website, https://www.biostemtechnologies.com/, under the heading “Investors–SEC Filings.” In addition, our Audit Committee Charters as well as our Code of Business Conduct and Ethics, are on our website under the heading “Investors–Corporate Governance.” The reference to our website does not constitute incorporation by reference of any information contained on that site.

Item 1A. Risk Factors

An investment in our securities involves a high degree of risk. In addition to the other information contained in this Registration Statement on Form 10, prospective investors should carefully consider the following risks before investing in our securities. If any of the following risks actually occur, as well as other risks not currently known to us or that we currently consider immaterial, our business, operating results and financial condition could be materially adversely affected. As a result, the trading price of our common stock could decline, and you may lose all or part of your investment in our common stock. The risks discussed below also include forward-looking statements, and our actual results may differ substantially from those discussed in these forward-looking statements. See “Cautionary Note Regarding Forward-Looking Statements” in this Form 10. In assessing the risks below, you should also refer to the other information contained in this Form 10, including the financial statements and the related notes, before deciding to purchase any of our securities.

Summary of Risk Factors

Below is a summary of the principal factors that make an investment in our common stock speculative or risky. This summary does not address all of the risks that we face. Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading "Risk Factors":

Risk Related to Our Business and Industry:

Risks Related to Government Regulation of Our Products:

Risks Related to Reimbursement for our Products:

Risks Related to our Common Stock:

Risks Related to Our Business and Industry

We have a history of net losses and we may not be able to achieve or maintain profitability in the future.

We have incurred net losses over the last few years, and we may incur net losses in the future. We incurred net losses of $8,482,984 and $7,231,796 for the years ended December 31, 2023 and 2022, respectively, and had an accumulated deficit and working capital deficit of $45,624,117 and $3,021,835, respectively, as of December 31, 2023. Although we had net income of $6,286,028 and $9,543,420 for the three and six months ended June 30, 2024, respectively, as compared to a net loss of $2,855,026 and $6,435,114 for the three and six months ended June 30, 2023, the net income was primarily as a result of revenues earned from the sale of AW2 under the Distribution Agreement with the Distributor which we entered into in September 2023. We will continue to incur significant expenses for the foreseeable future as we expand our sales and marketing, research and development, and clinical activities and pursue applicable regulatory approvals. We may not be able to continue generating sufficient revenues to achieve or sustain profitability. Moreover, we may not be able to achieve, sustain or increase profitability. Our business and prospects must be evaluated in light of the expenses, delays, uncertainties and complications typically encountered by businesses in our stage of development operating in a competitive market. These include, but are not limited to, potential problems, delays or expenses relating to product development, governmental approvals or reimbursement for our products, competition, technological changes and uncertain market acceptance. In addition, if we are unable to manage growth effectively, our operating results could be materially and adversely affected. We may not be able to successfully control or address any or all of these risks, and the failure to adequately do so could cause our business, results of operations, and financial condition to suffer.

To date we have derived the majority of our revenues from the Distribution with the Distributor.

On September 8, 2023, we entered into the Distribution Agreement with the Distributor for the distribution of our AW2 product. During the year ended December 31, 2023, revenues earned from the sale of AW2 under the Distribution Agreement were $13,625,947. During the three and six months ended June 30, 2024, revenues earned from the sale of AW2 under the Distribution Agreement were $74,423,600 and $115,558,500, respectively. As of June 30, 2024 and December 31, 2023, accounts receivable due under this arrangement were $78,073,127 and $11,126,598, respectively. We reported net income for the first time on a US GAAP basis for the three and six months ended June 30, 2024. We had net income of $6,286,028 and $9,543,420 for the three and six months ended June 30, 2024, respectively, as compared to a net loss of $2,855,026 and $6,435,114, for the three and six months ended June 30, 2023, respectively.

We have an accumulated deficit of $36,080,697 as of June 30, 2024, and working capital surplus of $12,512,673 as of June 30, 2024. The change in our financial position was primarily due to revenue earned from the Distribution Agreement with the Distributor. Accordingly, we have derived the majority of our revenues from its Distribution and Services Agreement with the Distributor. If this Distribution and Services Agreement is breached or terminated by either party, particularly in the short-term our revenues may decrease substantially, and our results of operations and financial condition will be significantly harmed.

A material amount of our revenues and accounts receivable are concentrated in one or more customers. If we lose or experience a significant reduction in sales to such key customers, our revenues may decrease substantially and our results of operations and financial condition may be harmed.

A high concentration of our revenue and accounts receivable comes from a limited number of customers. Accordingly, in each year there may be a small number of customers from whom we generate our revenue. These customers may not be repeat purchasers and in each year it may be a different single purchaser or small number of purchasers from which we generate a large percentage of our revenues. We rely on these purchasers and there is a risk that these purchasers may be unable to make payment under their obligations to us, thereby affecting our revenues.

One customer, Venture Medical, accounted for approximately 82% of our consolidated revenue for the year ended December 31, 2023 and 98% of accounts receivable as of December 31, 2023. One customer accounted for approximately 30% of our consolidated revenue for the year ended December 31, 2022 and three customers accounted for approximately 81% of accounts receivable as of December 31, 2022. For the three and six months ended June 30, 2024, one customer, Venture Medical, accounted for approximately 99% of our consolidated revenue and 99% of accounts receivable as of June 30, 2024. For the three and six months ended June 30, 2023, there was no concentration of consolidated net revenues or accounts receivable in any customers.

Any payment issues encountered by these large customers would likely harm our financial condition and results of operations.

If we fail to comply with our obligations in the agreement under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensor, we could lose license rights that are important to our business.

We are party to an intellectual property license agreement that is important to our business, and we may enter into additional license agreements in the future. Our existing license agreement imposes, and we expect that future license agreements will impose, various obligations on us. Licensing of intellectual property is of critical importance to our business and involves complex legal, business and scientific issues. If disputes over intellectual property and other rights that we have licensed prevent or impair our ability to maintain our current licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product and this may affect our financial performance.

For example, on June 29, 2023, we entered into the License Agreement with Hesed, pursuant to which we license the rights to manufacture and commercialize AW2 from Hesed, which is an unrelated party that has ownership of, rights to (including intellectual property) and control of AW2 while we retain ownership of our proprietary BioREtain technology. Either party may terminate the License Agreement either by a notice of non-renewal at least 90 days prior to the renewal or at any time by giving 6 months prior written notice to the other party in the event of a breach of the License Agreement that cannot be cured, such as a breach of the confidentiality obligations or a breach that continues for 15 days after written notice to the breaching party. If the License Agreement is breached or terminated by either party, we will no longer have the rights to manufacture and commercialize our AW2 product and our revenues may decrease substantially, which would have a material adverse effect on our business, results of operations and financial condition.

To be commercially successful, we must demonstrate to physicians that our products are safe and effective alternatives to existing treatments and that our products should be used in their procedures.

We believe physicians will only adopt our products if they determine, based on experience, clinical data and published peer reviewed journal articles, that the use of our products in a particular procedure is a favorable alternative to conventional methods. Physicians also are more interested in using cost-effective products and may practice in settings like Accountable Care Organizations, or ACOs, or Medical Homes, where they face considerable cost-containment pressure. In general, physicians may be slow to change their medical treatment practices and use of our products for the following reasons, among others:

The degree of market acceptance of our products will continue to depend on a number of factors, including:

We believe recommendations for, and support of our products by, influential physicians are essential for market acceptance and adoption. If we do not receive this support (e.g., because we are unable to demonstrate favorable long-term clinical data), physicians and hospitals may not use our products, which would significantly reduce our ability to achieve expected revenue and would prevent us from sustaining profitability. In the course of conducting our business, we must comply with regulatory quality requirements, adequately address quality issues that may arise with our products, as well as defects in the materials that we use in manufacturing our products. Although we have established internal procedures to minimize risks that may arise from quality issues, we may not be able to eliminate or mitigate these risks and quality issues may arise in which case we would be subject to liability. If the quality of our products does not meet the expectations of regulators, physicians or patients, then we could be subject to regulatory sanctions and our brand and reputation could suffer and our business, results of operations and financial condition could be adversely impacted.

We may experience significant fluctuations in our quarterly and annual results.

Our annual and quarterly results of operations and key metrics may vary significantly in the future as they have in the past, particularly in light of our dependence on a limited number of high-value customer contracts, and period-to-period comparisons of our results of operations and key metrics may not be meaningful. Accordingly, the results of any one year or quarter should not be relied upon as an indication of future performance. For instance, as discussed above, we incurred net losses, an accumulated deficit and working capital deficit as of and for the years ended December 31, 2023 and 2022, but had net income for the three and six months ended June 30, 2024. On September 8, 2023, we entered into the Distribution Agreement with the Distributor for the commercialization of our AW2 product, which accounted for a significant amount of our revenues during the year ended December 31, 2023 and three and six months ended June 30, 2024. As a result, we reported positive net income for the first time on a US GAAP basis for the three and six months ended June 30, 2024.

Our results of operations and key metrics may continue to fluctuate as a result of a variety of factors, including:

These factors, many of which are outside of our control, and as a result, our results of operations and key metrics may not fully reflect the underlying performance of our business. Fluctuation in our annual or quarterly results may negatively impact the value of our securities. If our quarterly operating results fail to meet or exceed the expectations of securities analysts or investors, our stock price could drop suddenly and significantly. We believe the quarterly comparisons of our financial results are not always meaningful and should not be relied upon as the sole indicator of our future performance.

We are in a highly competitive and evolving field and face competition from well-established tissue processors, as well as new market entrants.

Our business is in a very competitive and evolving field. Competition from other tissue processors and other companies in our industry, and from research and academic institutions, is intense, expected to increase and subject to rapid change and could be significantly affected by new product introductions as well as changes in reimbursement that could favor certain products and competitors over others. Established competitors and newer market entrants are investing in additional clinical research that may allow them to gain further clinician usage, adoption and payer coverage of their products. In addition, consolidation and cost containment measures in the healthcare industry may cause hospitals to consolidate their purchases with suppliers that have a broad portfolio of products. This would continue to give rise to demands for price concessions, which could have an adverse effect on our business, results of operations and financial condition. Further, competitors may introduce placental-based membrane products in the future at more favorable pricing, adding new features or gaining additional reimbursement coverage, or utilize sales and marketing practices that negatively impact the industry. Further, they may copy our products outside the United States. The presence of this competition may lead to pricing pressure, which could have an adverse effect on our business, results of operations and financial condition.

Defects, failures or quality issues associated with our products could lead to product recalls or safety alerts, adverse regulatory actions, litigation, including product liability claims, and negative publicity that could erode our competitive advantage and market share and materially adversely affect our reputation, business, results of operations and financial condition.

Quality is extremely important to us and our customers due to the serious and costly consequences of product failure. Quality and safety issues may occur with respect to any of our products, and our future operating results will depend on our ability to maintain an effective quality control system and effectively train and manage our workforce with respect to our quality system. The development, manufacture and control of our products are subject to extensive and rigorous regulation by numerous government agencies, including the FDA. Compliance with these regulatory requirements, including but not limited to the FDA’s Quality System Regulation (QSR), CGTP, and adverse events/recall reporting requirements in the United States, is subject to continual review and is monitored rigorously through periodic inspections by the FDA.

The results of these inspections can include inspectional observations on FDA’s Form FDA-483, untitled letters, warning letters, or other forms of enforcement. If the FDA were to conclude that we are not in compliance with applicable laws or regulations, the FDA could take a number of regulatory actions, including preventing us from manufacturing or distributing any or all of our products or limiting the extent of our manufacturing or distribution, which could materially adversely affect our business. In addition, a prolonged interruption or limitation in the manufacturing or distribution of one or more of our products as a result of non-compliance could decrease our supply of products available for sale, which could reduce our net sales, gross profits and market share, as well as harm our overall business, prospects, financial condition and results of operations.

Our manufacturing facilities and those of our suppliers and independent sales agencies are also subject to periodic regulatory inspections. If the FDA were to conclude that we or our suppliers or sales agencies have failed to comply with any of these requirements, it could institute a wide variety of enforcement actions, ranging from a public warning letter to more severe sanctions, such as product recalls or seizures, orders for product detention or destruction, withdrawals, monetary penalties, consent decrees, injunctive actions to halt the manufacture or distribution of products, restrictions on operations or other civil or criminal sanctions. Civil or criminal sanctions could be assessed against our officers, employees, or us. Any adverse regulatory action against us or our suppliers or sales agencies, depending on its magnitude, may restrict us from obtaining needed supplies or effectively manufacturing, marketing and selling our products.

In addition, we cannot predict the results of future legislative activity or future court decisions, any of which could increase regulatory requirements, subject us to government investigations or expose us to unexpected litigation. Any regulatory action or litigation, regardless of the merits, may result in substantial costs, divert management’s attention from other business concerns and place additional restrictions on our sales or the use of our products. In addition, negative publicity, including regarding a quality or safety issue, could damage our reputation, reduce market acceptance of our products, cause us to lose customers and decrease demand for our products. Any actual or perceived quality issues may also result in issuances of FDA public safety communications or physician’s advisories against our products

or cause us to conduct voluntary recalls. Any product defects or problems, regulatory action, litigation, negative publicity or recalls could disrupt our business and have a material adverse effect on our business, results of operations and financial condition.

Rapid technological change could cause our products to become obsolete and if we do not enhance our product offerings through our research and development efforts, we may be unable to effectively compete.

The technologies underlying our products are subject to rapid and profound technological change. Competition intensifies as technical advances in each field are made and become more widely known. We can give no assurance that others will not develop services, products, or processes with significant advantages over the products, services, and processes that we offer or are seeking to develop. Any such occurrence could have a material and adverse effect on our business, results of operations and financial condition.

We plan to enhance and broaden our product offerings to expand our penetration of the wound care market in response to changing customer demands and competitive pressure and technologies, but we may not be successful. The success of any new product offering or enhancement to an existing product will depend on numerous factors, including our ability to:

If we do not develop and, when necessary, obtain regulatory clearance or approval for new products or product enhancements in time to meet market demand, or if there is insufficient demand for these products or enhancements, our results of operations will suffer. Our research and development efforts may require a substantial investment of time and resources before we are adequately able to determine the commercial viability of a new product, technology, material or other innovation. In addition, even if we are able to successfully develop enhancements or new generations of our products, these enhancements or new generations of products may not be covered or reimbursed by government health benefit programs such as Medicare or private health plans, may not produce sales in excess of the costs of development and/or may be quickly rendered obsolete by changing customer preferences or the introduction by our competitors of products embodying new technologies or features.

Many of our products depend on the availability of tissue from human donors, and any disruption in supply could adversely affect our business.

The success of our human tissue products depends upon, among other factors, the availability of tissue from human donors. Any failure to obtain tissue from our sources will interfere with our ability to effectively meet demand for our products incorporating human tissue. The availability of donated tissue could also be adversely impacted by regulatory changes, public opinion of the donor process and our own reputation in the industry. We may not be successful in our ability to scale tissue recovery efforts to meet the potential future demand of our pipeline. Obtaining adequate supplies of human tissue involves several risks, including limited control over availability (due to, for example, access to hospital accounts and the number of consenting mothers), quality, delivery schedules, and eligibility requirements. In addition, any interruption in the supply of any human tissue component could harm our ability to manufacture our products until a new source of supply, if any, could be found. We also utilize third-party providers of tissue collection services on an as-needed basis to mitigate risks but there can be no assurance that these third parties will be able to provide donated tissues at all times. We may be unable to find a sufficient alternative supply channel in a reasonable time period or on commercially reasonable terms, if at all, which would have an adverse effect on our business, results of operations and financial condition.

We depend on our senior leadership team and may not be able to retain or replace these employees or recruit additional qualified personnel, which would harm our business, results of operations and financial condition.

Our business and success are materially dependent on attracting and retaining members of our senior leadership team to formulate and execute our business plans. Our future success will also depend, in part, upon our ability to attract and retain skilled personnel, including sales, managerial and technical personnel. There can be no assurance that we will be able to continue to find and attract additional qualified employees to support our expected growth or retain any such personnel.

Our revenues depend on adequate reimbursement from public and private insurers and health systems and changes to the ways in which our products are reimbursed in various sites of service could adversely impact our financial results.

Our success depends on the extent to which our customers receive adequate reimbursement for the costs of our products and related treatments from third-party payers, including government healthcare programs, such as Medicare and Medicaid, as well as private insurers and health systems. Government and other third-party payers attempt to contain healthcare costs by limiting both coverage and the level of payment of medical products, particularly new products. Therefore, significant uncertainty may exist as to the reimbursement status of new healthcare products by third-party payers. The reimbursement landscape for our products varies depending upon the site in which the products are administered. If we are not successful in obtaining adequate coverage and payment for our products from these third-party payers in one or more of the sites of service where our products are used, it could have an adverse effect on market acceptance of our products. Inadequate reimbursement levels would likely also create downward price pressure on our products. Even if we do succeed in obtaining widespread coverage and reimbursement rates or policies for our products, future changes in coverage or payment rates or policies could have a negative impact on our business, financial condition and results of operations. Changes in the coverage and payment environment as described above could result in declines in our revenue that would adversely affect our business, financial condition and results of operation.

Further, we have experienced some reluctance by payers to cover our products under certain circumstances, including for applications other than those for which we have published clinical efficacy data. Since 2022, several wide-ranging proposals have been published for public comment, including relating to payment methodology within the physician office, with potential to change how CMS reimburses for skin substitute products at a national level. At a regional level, three MACs signaled their intent to change coverage guidance by moving LCDs through the process. While these were ultimately withdrawn, all of the MACs released proposed LCDs that, if finalized, would eliminate Medicare coverage for our products until acceptable peer-reviewed evidence is developed to support coverage. If the national reimbursement proposals were to be adopted, it would significantly change Medicare policies governing the reimbursement of skin substitute products principally when used for the care of chronic wounds.

Interruptions in the supply of our products or inventory loss may adversely affect our business, results of operations and financial condition.

Our products are manufactured using technically complex processes requiring specialized facilities, highly specific raw materials and other production constraints. The complexity of these processes, as well as strict company and government standards for the manufacture and storage of our products subjects us to production risks. In addition to ongoing production risks, process deviations or unanticipated effects of approved process changes may result in non-compliance with regulatory requirements including stability requirements or specifications. Most of our products must be stored and transported within a specified temperature range. For example, if environmental conditions deviate from that range, our products’ remaining shelf-lives could be impaired or their safety and efficacy could be adversely affected, making them unsuitable for use. These deviations may go undetected. The occurrence of actual or suspected production and distribution problems can lead to lost inventories, and in some cases recalls, with consequential reputational damage and the risk of product liability. The investigation and remediation of any identified problems can cause production delays and result in substantial additional expenses. Any future failure in the storage or manufacture of our products or loss in supply could result in a loss of our market share and negatively affect our revenues and operations.

Increased prices for, or unavailability of, raw materials used in our products could adversely affect our business, results of operations and financial condition.

Our profitability is affected by the prices of the raw materials used in the manufacture of our products. These prices may fluctuate based on a number of factors beyond our control, including changes in supply and demand, general economic conditions, labor costs, fuel related delivery costs, competition, excise and other indirect taxes and government regulation. Due to the highly competitive nature of the healthcare industry and the cost containment efforts of our customers and third-party payers, we may be unable to pass along cost increases for key components or raw materials through higher prices to our customers. If the cost of key components or raw materials increases, and we are unable fully to recover these increased costs through price increases or offset these increases through other cost reductions, we could experience lower margins and profitability. Significant increases in the prices of raw materials that cannot be recovered through productivity gains, price increases or other methods could adversely affect our business, results of operations and financial condition.

We contract with and are dependent upon our distributors.

We market and distribute products to medical professionals, such as podiatrists and plastic surgeons, indirectly primarily through distributors. In 2023, approximately 82% of our sales were through our relationships with distributors. If our relationships with our distributors were terminated for any reason, it could materially and adversely affect our revenues and profits. Because the distributor often controls the customer relationships within its territory, there is a risk that if our relationship with the distributor ends, our relationship with the customer will be lost. Because our distributors are not employees, there is a risk we will be unable to ensure that our sales processes, compliance safeguards, and related policies will be adhered to despite our communication and training of distributors regarding these requirements. Furthermore, if we fail to maintain relationships with our distributor there could be an adverse effect on our business, results

of operations, and financial condition. We may obtain the assistance of additional distributors and independent sales agents to sell products in certain sales channels, particularly in territories and fields where agents are commonly used. Our success is partially dependent upon our ability to train, retain and motivate our distributors and their representatives to appropriately and compliantly sell our products in certain territories or fields. They may not be successful in implementing our marketing plans or compliance safeguards. Some of our distributors do not sell our products exclusively and may offer similar products from other companies. Our distributors may terminate their contracts with us, may devote insufficient sales efforts to our products or may focus their sales efforts on other products that produce greater commissions for them, which could have an adverse effect on our business, results of operations and financial condition. We also may not be able to find additional independent sales agencies and distributors who will agree to appropriately and compliantly market or distribute our products on commercially reasonable terms, if at all. If we are unable to establish new independent sales representative and distribution relationships or renew current distribution agreements on commercially acceptable terms, our business, financial condition, and results of operations could be materially and adversely affected.

Moreover, pursuant to the Distribution Agreement with the Distributor of our AW2 product, the distributor provides many of the services relating to the commercialization of that product, including, among other things, insurance coverage and eligibility, claims processing, quality assurance, inventory management and returns, and other day-to-day operations services. Our reliance on this third party to perform these services on our behalf increases the risk that we are unable to ensure that our sales processes, compliance safeguards, and related policies will be adhered to and any noncompliance with these policies or regulations may adversely affect our business, financial condition, and results of operations and exacerbate the other risks described in this section.

Disruption of our manufacturing facilities could adversely affect our business, financial condition and results of operations.

We own and operate a state-of-the-art, AATB accredited, cGTP compliant manufacturing facility located in Pompano Beach, Florida, which is a 6,100 sq. ft. manufacturing facility with multiple ISO 5 and ISO 7 suites designed for commercial production of HCT/Ps. Our business depends upon the continued operation of our manufacturing facility. Risks that could impact our ability to use these facilities include the occurrence of natural and other disasters, the outbreak of pandemics, and the need to comply with the requirements of directives from government agencies, including the FDA. If our manufacturing facilities were to become unavailable, this could have a material adverse effect on our business, financial condition and results of operations during the period of such unavailability.

We depend on our senior leadership team and may not be able to retain or replace these employees or recruit additional qualified personnel, which would harm our business, results of operations and financial condition.

Our business and success are materially dependent on attracting and retaining members of our senior leadership team to formulate and execute our business plans. Our future success will also depend, in part, upon our ability to attract and retain skilled personnel, including sales, managerial and technical personnel. There can be no assurance that we will be able to continue to find and attract additional qualified employees to support our expected growth or retain any such personnel.

We will need to continue to expand our organization, and managing growth may be more difficult than expected.

Managing our growth may be more difficult than we expect. We anticipate that a period of significant expansion will be required to penetrate and service the markets for our existing and anticipated future products and to continue to develop new products. This expansion will place a significant strain on management, operational and financial resources. To manage the expected growth of our operations and personnel, we must both modify our existing operational and financial systems, procedures and controls and implement new systems, procedures and controls. We must also expand our finance, administrative, and operations staff. Management may be unable to hire, train, retain, motivate and manage necessary personnel or to identify, manage and exploit existing and potential strategic relationships and market opportunities.

Our principal business operations are located in Florida and may be subject to interruptions caused by hurricanes and other natural disasters.

Our physical facilities and employees are all located in Florida and thus our business operations are more susceptible than businesses located in other parts of the country to interruptions caused by hurricanes and flooding. These natural disasters pose a risk of damage to our facilities and interruptions to our business, which could be prolonged, as a result of extended power outages, the unavailability of our employees during periods when they must attend to personal circumstances, and the inability of third parties to provide necessary services to us due to similar factors. Damage to our facilities and extended interruption of our business could result in lost revenues and other material adverse consequences for our business, which may not be adequately covered by insurance or for which insurance may not be available.

The formation of physician-owned distributorships (“PODs”) could result in increased pricing pressure on our products or harm our ability to sell our products to physicians who own or are affiliated with those distributorships.

PODs are medical product distributors that are owned, directly or indirectly, by physicians. These physician owners may derive a proportion of their revenue from selling or arranging for the sale of medical products for use in procedures they perform on their own patients

at hospitals or ambulatory surgery centers that agree to purchase from or through the POD, or that otherwise furnish ordering physicians with income that is based directly or indirectly on those orders of medical products. The Office of Inspector General (“OIG”) of the Department of Health & Human Services has issued a Special Fraud Alert on PODs, indicating that they are inherently suspect under the federal Anti-Kickback Statute.

Our commercial strategy emphasizes selling directly to healthcare providers principally through independent medical distributors and also through direct and contract salesforces. To our knowledge, we do not directly sell to or distribute any of our products through PODs. The number and strength of PODs in the industry may continue to grow as economic pressures increase throughout the industry and hospitals, ambulatory surgery centers, insurers and physicians search for ways to reduce costs, and, in the case of the physicians, identify additional sources to increase their incomes. These companies and the physicians who own, or partially own, PODs may have significant market knowledge, access to and influence on the physicians who use our products and the hospitals that purchase our products, and we may not be able to compete effectively for business from physicians who own PODs or for sales to healthcare provider customers that exclusively purchase through PODs..

We face the risk of product liability claims and may not be able to obtain or maintain adequate product liability insurance.

While we have had a low product complaint and adverse event rate historically, our business exposes us to the risk of product liability claims that are inherent in the manufacturing, processing and marketing of human tissue products. We may be subject to such claims if our products cause, or appear to have caused, an injury. Claims may be made by patients, healthcare providers or others selling our products. Product liability claims can be expensive to defend (regardless of merit), divert our management’s attention, result in substantial damage awards against us, harm our reputation, and generate adverse publicity, which could result in the withdrawal of, or reduced acceptance of, our products in the market.

Although we have product liability insurance that we believe is adequate, this insurance is subject to deductibles and coverage limitations, and we may not be able to maintain this insurance at an acceptable cost or on acceptable terms or be able to secure increased coverage (if needed), nor can we be sure that existing or future claims against us will be covered by our product liability insurance. Moreover, the existing coverage of our insurance or any rights of indemnification and contribution that we may have may not be sufficient to offset existing or future claims. If we are unable to maintain product liability insurance at an acceptable cost or on acceptable terms with adequate coverage or otherwise protect ourselves against potential product liability claims or we underestimate the amount of insurance we need, we could be exposed to significant liabilities, which may harm our business. A product liability claim or other claim with respect to uninsured liabilities or for amounts in excess of insured liabilities could result in significant costs and significant harm to our business. Even if a claim is not successful, defending such claim would be time-consuming and expensive, may damage our reputation in the marketplace, and would likely divert our management’s attention.

The products we process are derived from human tissue and therefore have the potential for disease transmission.

The utilization of human tissue creates the potential for transmission of communicable disease, including, without limitation, human immunodeficiency virus, viral hepatitis, syphilis and other viral, fungal or bacterial pathogens. We are required and have implemented controls to comply with federal and state regulations intended to prevent communicable disease transmission.

New communicable diseases emerge in the human population from time to time. If a new communicable disease has a period during which time the causative agent is present in human cells or tissue but symptoms are not present or linked to the causative agent, it is possible that cell and tissue donations could be contaminated by that infectious agent. Typically, early in an outbreak of a new disease, tests for the causative agent do not exist. During this early phase, we must rely on screening of donors and patients (e.g., for behavioral risk factors or physical symptoms) to reduce the risk of cell and tissue contamination. Screening methods are generally less sensitive and specific than a direct test as a means of identifying potentially contaminated cell and tissue units. In addition, screening methods may not be effective in instances where screened individuals are not symptomatic, do not have known risk factors, or where risk factors or symptoms for a new infectious agent are not understood.

During the early phase of an outbreak of a new communicable disease, our ability to manufacture safe products would depend on the manufacturing process’ capacity to inactivate or remove the infectious agent. We maintain strict quality controls designed in accordance with CGTP to help ensure the safe procurement and processing of our tissue, including terminal sterilization of our products. These controls are intended to prevent the transmission of communicable disease. However, risks exist with any human tissue implantation. To the extent that a product’s manufacturing process is inadequate to inactivate or remove an infectious agent, including any known or new infectious agent,our ability to manufacture and distribute that product would be impaired.

If a new communicable disease were to emerge in the human population, the regulatory and public health authorities could impose precautions to limit the transmission of the disease that would impair our ability to procure cells or tissues, manufacture our product candidates, or both. Such precautionary measures could be taken even before there is conclusive medical or scientific evidence that a disease poses a risk for HCT/Ps.

In recent years, new testing and viral inactivation methods have been developed that more effectively detect and inactivate infectious viruses in collected cells and tissues. There can be no assurance, however, that such new testing and inactivation methods will adequately screen for, and inactivate, all infectious agents in the cells and tissues used in the production of our products.

Also, negative publicity concerning disease transmission from other companies’ improperly processed donated tissue could have a negative impact on the demand for our products and adversely affect our business, financial condition and results of operations.

We may expand or contract our business through acquisitions, licenses, investments, and other commercial arrangements with other companies or technologies, which may adversely affect our business, results of operations and financial condition.

We periodically evaluate opportunities to acquire companies or divisions, technologies, products, and rights through licenses, distribution agreements, investments, and outright acquisitions to grow our business. In connection with one or more of those transactions, we may:

Any of these items could materially and adversely affect our revenues, financial condition, and profitability. Business acquisitions also involve the risk of unknown liabilities associated with the acquired business, which could be material. Additional liabilities related to acquisitions could include lack of compliance with government regulations that could subject us to investigation and civil and criminal sanctions. For example, we may acquire a company that was not compliant with FDA quality requirements or was making payments or other forms of remuneration to physicians to induce them to use their products. Incurring unknown liabilities or the failure to realize the anticipated benefits of an acquisition could materially and adversely affect our business and we may lose our entire investment or be unable to recover our initial investment, which could include the cost of acquiring licenses or distribution rights, acquiring products, purchasing initial inventory, or investments in early stage companies. Inability to recover our investment, or any write off of such investment, associated goodwill, or assets, could have a material and adverse effect on our business, results of operations and financial condition.

New lines of business or new products and services may subject us to additional risks.

From time to time, we may implement or may acquire new lines of business or we may offer new products and services within existing lines of business. There are risks and uncertainties associated with these efforts, particularly in instances where the markets are not fully developed or are evolving such as the regulation of physician-owned durable medical equipment suppliers that sell our wound care supplies. In developing and marketing new lines of business and new products and services, we may invest significant time and resources. External factors, such as regulatory compliance obligations, competitive alternatives, lack of market acceptance, and shifting market preferences, may also affect the successful implementation of a new line of business or a new product or service. Failure to successfully manage these risks in the development and implementation of new lines of business or new products or services could have a material adverse effect on our business, results of operations and financial condition.

We may implement a product recall or voluntary market withdrawal, which could significantly increase our costs, damage our reputation, disrupt our business and adversely affect our business, results of operations and financial condition.

The processing and marketing of our tissue products involves an inherent risk that our tissue products or processes may not meet applicable quality standards and requirements. In the event that one or more of our products experiences a failure to meet such standards and requirements, we may voluntarily implement a recall or market withdrawal or may be required to do so by a regulatory authority.

A recall or market withdrawal of one of our products could be costly and may divert management resources. A recall or withdrawal of one of our products, or a similar product processed by another entity, also could impair sales of our products as a result of confusion concerning the scope of the recall or withdrawal, or as a result of the damage to our reputation for quality and safety.

A cyberattack or significant disruptions of our information technology systems could adversely affect our business, results of operation and financial condition.

A cyberattack, a disruption in availability, or the unauthorized alteration of systems or data could adversely affect our business, results of operations and financial condition. We rely on technology for day-to-day operations as well as positioning to enhance our stance in the market. We generate intellectual property that is central to the future success of the business and transmit large amounts of confidential information. Additionally, we collect, store and transmit confidential information of customers, patients, employees and third parties. We also have outsourced significant elements of our operations to third parties, including significant elements of our information technology infrastructure, and, as a result, we are managing many independent vendor relationships with third parties who may or could have access to our confidential information. The continually changing threat landscape of cybersecurity today makes our systems potentially vulnerable to service interruptions or to security breaches from inadvertent or intentional actions by our employees, partners, and vendors, and from attacks by malicious third parties, including supply chain attacks originating at our third-party partners. Such attacks are of ever-increasing levels of sophistication. Attacks are made by individuals or groups that have varying levels of expertise, some of which are technologically advanced and well-funded including, without limitation, nation states, organized criminal groups and hacktivists organizations.

To ensure protection of our information, we have invested in cybersecurity and have implemented processes and procedural controls to maintain the confidentiality and integrity of such information. We measure these controls and their success through a cybersecurity framework that is based on industry standards. While we have invested in the protection of our data and technology, there can be no guarantees that our efforts will prevent all service interruptions or security breaches. Any such interruption or breach of our systems could adversely affect our business operations and result in the loss of critical or sensitive confidential information or intellectual property, and could result in financial, legal and reputational harm to our business, including legal claims and proceedings, liability under laws that protect the privacy of personal information, government enforcement actions and regulatory penalties, as well as remediation costs. We also maintain cyber liability insurance. However, this insurance may not be sufficient to cover the financial, legal or reputational losses that may result from an interruption or breach of our systems.

If a breach of our measures protecting personal data covered by HIPAA state privacy laws, or state data breach notification laws occurs, we may incur significant liabilities and operational disruptions.

The Health Insurance Portability and Accountability Act of 1996, as amended, or HIPAA, and the regulations that have been issued under it, impose certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy and security of protected health information. The requirements and restrictions apply to “covered entities” (which include health care providers and insurers) as well as to their “business associates” that receive access to protected health information from such covered entities to provide services to or perform certain activities on their behalf. The statute and regulations also impose notification obligations on covered entities and their business associates in the event of a breach of the privacy or security of protected health information. We provide services to and on behalf of customers that are HIPAA covered entities or business associates and occasionally receive protected health information from such customers in the course of our business. As such, we believe that we are HIPAA business associates and therefore subject to HIPAA’s requirements and restrictions with respect to handling such protected health information, and have executed business associate agreements with certain customers. We also collect, use, and disclose personally identifiable information that is governed by state privacy laws, such as the California Consumer Privacy Act, as amended.

The secure processing, storage, maintenance, and transmission of this critical information are vital to our operations and business strategy, and we devote significant resources to protecting such information. Although we take reasonable measures to protect sensitive data from unauthorized access, use, or disclosure, no security measures can guarantee the security of information, and our information technology and infrastructure may be vulnerable to attacks by hackers or viruses or breached due to employee or contractor error, malfeasance or other malicious or inadvertent disruptions. Any such breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen. Any such access, breach, or other loss or unauthorized use or disclosure of information could result in legal claims or proceedings, and liability under federal or state laws that protect the privacy or security of identifiable information, such as HIPAA, state privacy laws, and state data breach notification laws, and regulatory penalties. Notice of breaches may be required to affected individuals, the Secretary of Health and Human Services or other state, federal or foreign regulators, and for extensive breaches, notice may need to be made to the media or state attorneys general. Such a notice could harm our reputation and our ability to compete.

Unauthorized access, loss or dissemination could also disrupt our operations (including our ability to conduct our analysis, provide test results, bill payors or patients, process claims and appeals, provide customer assistance, conduct research and development activities, collect, process and prepare company financial information, provide information about our tests and other patient and health care provider education and outreach efforts through our website, and manage the administrative aspects of our business) and damage our reputation, any of which could adversely affect our business. There can be no assurance that we will be successful in preventing cyberattacks or successfully mitigating their effects. To the extent that any disruption or security breach results in a loss of or damage to our data or applications or our customers and any other third party’s data, or inappropriate disclosure or theft of confidential, proprietary or personal information, we could incur substantial liability, suffer reputational damage or poor financial performance, or become the subject of litigation and/or regulatory actions by state, federal or non-US authorities, any of which could adversely affect our business.

It is possible the data protection laws may be interpreted and applied in a manner that is inconsistent with our practices. If so, this could result in government-imposed fines or orders requiring that we change our practices, which could adversely affect our business. In addition, these privacy regulations may differ from country to country and state to state, and may vary based on whether testing is performed in the United States or in the local country. Complying with these various laws and regulations could cause us to incur substantial costs or require us to change our business practices and compliance procedures in a manner adverse to our business. Further, compliance with data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. We can provide no assurance that we are or will remain in compliance with diverse privacy and security requirements in all of the jurisdictions in which we do business. If we fail to comply or are deemed to have failed to comply with applicable privacy protection laws and regulations such failure could result in government enforcement actions and create liability for us, which could include substantial civil and/or criminal penalties, as well as private litigation and/or adverse publicity that could negatively affect our operating results and business.

Public health pandemics or outbreaks could adversely impact our business.

Our operations may be affected by the outbreak of public health pandemics or outbreaks. The ultimate disruption which may be caused by any particular outbreak is uncertain; however, it may result in a material adverse impact on our financial position, operations and cash flows. Possible areas that may be affected include, but are not limited to, negative impact on our workforce, unavailability of professional services and other resources, disruption in supply chain that may interrupt the supply of human tissue component needed to manufacture our products, restrictions imposed by local governments, or disruption to credit markets necessary for the success of our business model.

Risks Related to Government Regulation of Our Products

We conduct business in a heavily regulated industry, and failure to comply with applicable laws and regulations pertaining to our business could result in substantial penalties, damage our reputation, and have a material adverse effect on our business and operations.

The life sciences and health care industries are highly regulated, and there can be no assurance that the regulatory environment in which we operate will not change significantly and adversely to us in the future. Areas of the regulatory environment that may affect our ability to conduct business include, without limitation:

In particular, the laws and regulations governing the marketing of HCT/Ps are extremely complex and, in many instances, there are no significant regulatory or judicial interpretations of these laws and regulations. For example, our HCT/Ps are, and may in the future be, actively regulated by the FDA pursuant to the Section 361 of the Public Health Services Act (“PHSA”). Among other things, pursuant to

the PHSA and its implementing regulations, the FDA regulates the research, design, testing, manufacturing, safety, labeling, storage, record keeping, marketing and promotion and sales and distribution of HCT/Ps in the United States to ensure that HCT/Ps distributed domestically are safe and effective for their intended uses. If we fail to adequately comply with the requirements for the HCT/Ps we offer that the FDA currently regulates as a HCT/P, our business operations may be harmed.

Federal and state fraud and abuse and similar laws are frequently enforced by the respective governments and can lead to costly and time-consuming investigations as well as litigation. The government may consider some of our marketing practices non-compliant with applicable laws. This may lead to significant fines and the exclusion form participation in government healthcare programs (e.g., Medicare and Medicaid).

The FDA may in the future determine that certain of our products that are, or are derived from, human cells or tissues, do not qualify for regulation solely under Section 361 of the Public Health Service Act (“Section 361”), and may require that we revise our labeling and marketing claims for these products or that we suspend sales of such products until FDA pre-market clearance or approval is obtained, which could adversely affect our business, results of operations, and financial condition.

The products we manufacture and process are derived from human tissue. Amniotic and other birth tissue have generally been regulated as HCT/Ps and are therefore eligible to be subject to regulation solely under Section 361 (“Section 361 HCT/P”) depending on whether the specific product at issue and the claims made for it are consistent with the applicable criteria. HCT/Ps that do not meet these criteria are subject to more extensive regulation as drugs, medical devices, biological products, or combination products. These HCT/Ps must comply with both the FDA’s requirements for HCT/Ps and the requirements applicable to biologics, devices, or drugs, as applicable, including pre-market clearance, approval, or licensure from the FDA. Obtaining FDA pre-market clearance, approval, or licensure involves significant time and investment by us.

While we believe that we are currently in material compliance with applicable laws and regulations as historically enforced by the FDA, we cannot assure you that the FDA will agree with our determination; and a determination that we have violated these laws and regulations, or a public announcement that we are being investigated for possible violations, could adversely affect our business, prospects, results of operations, or financial condition.

Any future regulatory changes could also have adverse consequences for us and make it more difficult or expensive for us to conduct our business by requiring pre-market clearance, approval, or licensure and compliance with additional post-market regulatory requirements with respect to our products. For example, the FDA may in the future impose conditions, such as labeling restrictions, or requirements that one or more of our products be manufactured in compliance with current good manufacturing practices (“cGMP”) such as those currently applicable to drugs, biologics, or medical devices, which would require significant additional time and cost investments by us. Moreover, increased regulatory scrutiny within the industry in which we operate could lead to increased regulation of HCT/Ps, including Section 361 HCT/Ps, which could ultimately increase our costs and adversely impact our business, results of operations and financial condition.

Obtaining and maintaining any necessary regulatory approvals, including conducting clinical trials, for certain of our products or potential products could be expensive and time consuming.

Where applicable, the process of obtaining regulatory clearances, approvals, or licensures to market a drug, medical device, biological product, or a combination product from the FDA may be costly and time consuming, and such clearances, approvals, or licensures may not be granted on a timely basis, or at all. The FDA may take the position that some of the products that we currently market are not Section 361 HCT/Ps and require, among other things, a New Drug Application, Biologics License Application, 510(k) clearance, or Premarket Approval from the FDA. Some of the future products and enhancements to our current products that we may develop or may acquire and market may require marketing clearance, approval, or licensure from the FDA. However, if required, clearance, approval, or licensure may not be granted with respect to any of our products or enhancements and further FDA review may add delays that could adversely affect our ability to market such products or enhancements.

If FDA disagrees that any of our products is a Section 361 HCT/P, the process of developing and executing clinical trials and manufacturing processes that would be necessary to support FDA approval, licensure, or clearance would require the expenditure of substantial time, effort and financial resources and may take years to complete, including costs incurred on top of those fees incurred as part of conducting various clinical studies while marketing our products under Section 361. Additionally, the FDA may limit the indications for use or place other conditions on any approvals, licensures, or clearances that could restrict the commercial application of the products. If we do receive approval, licensure, or clearance, some types of changes to the approved, licensed, or cleared product(s), such as adding new indications or doses, manufacturing changes and additional labeling claims, would be subject to further testing requirements and further FDA review and approval. Our revenues could be adversely affected if the FDA limited the indications for use or required other conditions that restrict the commercial application of our products.

Additionally, there are significant costs associated with clinical trials that can be difficult to accurately estimate. Clinical trials may not be successful or may return results that do not support approval, licensure, or clearance. Moreover, the results of early clinical trials are not necessarily predictive of future results, and any product we advance into clinical trials may not have favorable results in later clinical trials. Our interpretation of data and results from our clinical trials does not ensure that we will achieve similar results in future clinical trials. In addition, clinical data are often susceptible to various interpretations and analyses, and many companies that have believed their products performed satisfactorily in earlier clinical trials or retrospective studies have nonetheless failed to replicate results in later clinical trials.

If any of our products cause or contribute to a death, serious injury, or adverse reaction, we will be required to report such death, serious injury, or adverse reaction under applicable HCT/P reporting regulations, and such events can result in voluntary corrective actions or agency enforcement actions.

Under FDA HCT/P reporting regulations, HCT/P manufacturers are required to report to the FDA information that a HCT/P has or may have caused or contributed to a death, serious injury, or adverse reaction. If such a death, serious injury, or adverse reaction were to occur, and we or our collaborators are unable to demonstrate that the adverse events were caused by factors other than our or our collaborator’s products, regulatory authorities could order us to remove, recall, destroy, or cease manufacturing the affected HCT/P. Any of these occurrences may harm our and our collaborators’ ability to manufacture, identify and develop HCT/Ps, and may significantly harm our business, financial condition, result of operations, and prospects.

Our business is subject to extensive regulation by the FDA and other authorities, which is costly, and our failure to comply could result in negative effects on our business, results of operations and financial condition.

The FDA has specific regulations governing our tissue-based products, or HCT/Ps. The FDA has broad post-market and regulatory and enforcement powers, even for Section 361 HCT/Ps. The FDA’s regulation of HCT/Ps includes requirements for registration and listing of products, donor screening and testing, processing and distribution, labeling, record keeping and adverse-reaction reporting, and inspection and enforcement.

HCT/Ps that are regulated as drugs, biological products, medical devices or combination products are subject to even more stringent regulation by the FDA. Even if pre-market clearance, approval or licensure is obtained, the licensure, approval or clearance may place substantial restrictions on the indications for which the product may be marketed or to whom it may be marketed, may require warnings to accompany the product or impose additional restrictions on the sale or use of the product. In addition, regulatory approval is subject to continuing compliance with regulatory standards, including the FDA’s cGMP or quality system regulations.

If we fail to comply with applicable FDA or state regulations regarding our tissue products, the FDA or state authorities could take enforcement action, including, without limitation, any of the following sanctions and the manufacture of our products or processing of our tissue could be delayed or terminated:

Any of these sanctions could also result in higher than anticipated costs or lower than anticipated sales and have a material adverse effect on our reputation, business, results of operations and financial condition.

The FDA’s regulation of HCT/Ps may continue to evolve. Complying with any such new regulatory requirements may entail significant time delays and expense, which could have an adverse effect on our business, results of operations and financial condition.

The AATB has issued operating standards for tissue banking. Compliance with these standards is a requirement in order to become an accredited tissue bank. In addition, some states have their own tissue banking regulations.

In addition, procurement of certain human organs and tissue for transplantation is subject to the restrictions of various federal and state regulations such as the NOTA, which prohibits the transfer of certain human organs, including skin and related tissue for valuable

consideration, but permits the reasonable payment associated with the removal, transportation, implantation, processing, preservation, quality control and storage of human tissue and skin. We reimburse tissue banks, hospitals and physicians for their services associated with the recovery and storage of donated human tissue. Although we have independent third-party appraisals that confirm the reasonableness of the service fees we pay, if we were to be found to have violated NOTA’s prohibition on the sale or transfer of human tissue for valuable consideration, we could potentially be subject to fines or criminal enforcement sanctions, which could adversely affect our results of operations.

Finally, we and other manufacturers of skin substitutes are required to provide ASP information to CMS on a quarterly basis. The Medicare payment rates are updated quarterly based on this ASP information. We rely upon a number of assumptions as permitted by law in calculating the ASP that we consider reasonable, including assumptions regarding the BFSF paid to service providers. Given the lack of guidance or clarification from HHS and CMS regarding certain aspects of these calculations, it is possible that our calculations of average ASP may be challenged by regulators or in qui tam actions. If we are found to have made a misrepresentation in the reporting of ASP, we may be subject to civil monetary penalties of up to $16,630 for each misrepresentation for each day in which the misrepresentation was applied. Manufacturers found to have submitted false ASP data are subject to civil monetary penalties of up to $230,464 per item of false information. False Claims Act liability and criminal liability can also attach.

We may be subject to fines, penalties, injunctions and other sanctions if we are deemed to be promoting our products for uses that require, but lack, regulatory approval.

The FDA and the FTC regulate the advertising and promotion of HCT/Ps to ensure that the claims made are consistent with those permitted by the PHSA or other applicable laws, that there are adequate and reasonable data to substantiate the claims and that the promotional labeling and advertising is neither false nor misleading in any respect. If the FDA or FTC determines that any of our advertising or promotional claims are false, misleading, not substantiated or not permissible, we may be subject to enforcement actions, including warning letters, and we may be required to revise our promotional claims and make other corrections or restitutions.

As a general rule, FDA regulations require that the marketing of Section 361 HCT/Ps, which do not require FDA licensure, approval, or clearance, only be for homologous uses, and that the promotion of any licensed biological products, approved drugs, or approved or cleared devices only be for FDA-licensed, -approved, or -cleared indications. Generally, unless they are later licensed, approved, or cleared by FDA for other uses, the FDA contends that we may not make claims about the safety or effectiveness of our Section 361 products, or promote them as safe or effective, for uses other than homologous uses. Such limitations present a risk that the FDA or other federal or state law enforcement authorities could determine that the nature and scope of our sales, marketing and support activities, though designed to comply with all FDA requirements, constitute the promotion of our products for a non-homologous or unapproved use in violation of the federal PHSA or FDCA. We also face the risk that the FDA or other governmental authorities might pursue enforcement based on past activities that we have discontinued or changed, including prior sales activities, marketing materials, arrangements with institutions and doctors, educational and training programs and other activities.

Investigations concerning the promotion of unapproved product uses and related issues are typically expensive, disruptive and burdensome and generate negative publicity. If our promotional activities are found to be in violation of the law, we may face significant legal action, fines, penalties, and even criminal liability and may be required to substantially change our sales, promotion, grant and educational activities. There is also a possibility that we could be enjoined from selling some or all of our products for any unapproved use. In addition, as a result of an enforcement action against us or any of our executive officers, we could be excluded from participation in government healthcare programs such as Medicare and Medicaid.

While we believe we are fully in compliance with the FDA's Guidance on Section 361 HCT/Ps, there can be no assurance that we have correctly interpreted the FDA Guidance, or that we will not need to discontinue marketing a product and/or may be subject to fines, penalties, injunctions, and other sanctions if we are deemed to be promoting the use of our products for unapproved uses. Such regulatory penalties by the FDA could adversely affect our business and results of operations.

We and our sales representatives, whether employees or independent contractors, must comply with various federal and state anti-kickback, self-referral, false claims and similar laws, any breach of which could cause an adverse effect on our business, results of operations and financial condition.

Our relationships with physicians, hospitals and other healthcare providers are subject to various federal and state healthcare fraud and abuse laws. Healthcare fraud and abuse laws are complex, and, in some instances, even minor or inadvertent violations can give rise to liability. Possible sanctions for violation of the healthcare fraud and abuse laws include, without limitation, monetary fines, civil and criminal penalties, exclusion from participating in the federal and state healthcare programs, including, without limitation, Medicare, Medicaid, the VA health programs and TRICARE (the healthcare program administered by or on behalf of the U.S. Department of Defense for uniformed service members, including both those in active duty and retirees, as well as their dependents), and forfeiture of amounts collected in violation of such prohibitions. Many states have similar fraud and abuse laws that may apply to all payers, not just federal healthcare programs, imposing fines and penalties for violations A finding of a violation of one or more of these laws, or even a government

investigation or inquiry into the same, would likely result in a material adverse effect on the market price of our Common Stock, as well as on our business, results of operations, and financial condition.

The federal AKS is a criminal law that prohibits, among other things, any person from knowingly and willfully offering, paying, soliciting or receiving remuneration, directly or indirectly, in cash or in kind, to induce or reward referrals, purchases or orders or arranging for or recommending the purchase, order or referral of any item or service for which payment may be made in whole or in part by a federal healthcare program, such as the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include anything of value, whether in cash or in kind. Under the federal AKS as amended, a person or entity need not have actual knowledge of this statute or specific intent to violate it. Further, any claims for items or services resulting from a violation of the federal AKS may be considered false or fraudulent for purposes of the federal FCA. A conviction for violation of the AKS results in criminal fines and penalties, possible incarceration for individuals, and requires mandatory exclusion from participation in federal health care programs. Although there are a number of statutory exceptions and regulatory safe harbors to the federal AKS that protect certain common industry practices from prosecution, the exceptions and safe harbors are drawn narrowly, and arrangements may be subject to scrutiny or penalty if they do not fully satisfy all elements of an available exception or safe harbor. We have entered into consulting agreements, speaker agreements, research agreements and product development agreements with physicians and other healthcare providers, including some who may order or recommend our products or make decisions to use them. In addition, some of these providers own our stock, which they purchased in arm’s-length transactions on terms identical to those offered to non-physicians, or received stock awards from us in the past as consideration for services performed by them. Further, on occasion, we may provide free product or discounted product to our customers. In addition, in the course of our business with our customers or consultants, we may cover the costs of certain meals or travel expenses related to the conduct of business with us. We also compensate independent contractor sales agents for negotiating sales of our products to customers. While we believe these transactions generally meet the requirements of applicable laws, including the federal AKS and analogous state laws, it is possible that our arrangements with physicians and other healthcare providers may be questioned by regulatory or enforcement authorities under such laws, which could lead us to redesign the arrangements and subject us to significant civil or criminal penalties. In addition, we have conducted training sessions on these principles. If, however, regulatory or enforcement authorities were to view these arrangements as non-compliant with applicable laws, there would be risk of government investigations/inquiries or penalties. There is also risk that one or more of our employees or agents will disregard the rules we have established. Because our strategy relies on the involvement of physicians and other healthcare providers, who consult with us on the design of our products, perform clinical research on our behalf or educate other health care professionals about the efficacy and uses of our products, we could be materially impacted if regulatory or enforcement agencies or courts interpret our financial relationships with physicians and other healthcare providers, who refer or order our products to be in violation of applicable laws. This could harm our reputation and the reputations of the healthcare providers we engage to provide services on our behalf. In addition, the cost of noncompliance with these laws could be substantial since we could be subject to monetary fines and civil or criminal penalties, and we could also be excluded from federally-funded healthcare programs, including Medicare, Medicaid, VA and TRICARE.

The FCA imposes civil liability on any person or entity that knowingly submits, or causes the submission of, a false or fraudulent claim to the U.S. government. Damages under the FCA can be significant and consist of the imposition of fines and penalties. The FCA also allows a private individual or entity to sue on behalf of the government to recover civil penalties and treble damages as a whistleblower. FCA liability is potentially significant in the healthcare industry because the statute provides for treble damages and mandatory penalties of between $13,946 and $27,894 per false claim or statement for penalties assessed after February 12, 2024. Violations of the FCA can also potentially subject the Company to exclusion from federal healthcare programs.

Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payers if they are deemed to “cause” the submission of false or fraudulent claims. Claims deemed tainted by a violation of the federal AKS are false for purposes of the FCA. The DOJ on behalf of the federal government has previously alleged that the marketing and promotional practices of pharmaceutical and medical device manufacturers, including the off-label promotion of products or the payment of prohibited kickbacks to doctors and other healthcare providers, may violate the FCA, resulting in the submission of improper claims to federal and state healthcare programs such as Medicare and Medicaid. In certain cases, manufacturers have entered into criminal and civil settlements with the federal government under which they entered into plea agreements, paid substantial monetary amounts and entered into onerous corporate integrity agreements with the government that require, among other things, substantial reporting and remedial actions, as well as oversight and review by an outside entity, an Independent Review Organization (“IRO”), at substantial expense to us.

The HIPAA criminal federal healthcare fraud statute makes it criminal to knowingly and willfully execute, or attempt to execute, a scheme or artifice to defraud any health care benefit program or to obtain, by means of false or fraudulent pretenses, representations or promises, any of the money or property owned by, or under the custody or control of, any health care benefit program, in connection with the delivery of or payment for health care benefits, items or services.

There are federal and state laws requiring detailed reporting of manufacturer interactions with and payments to healthcare providers, such as the federal Physician Payments Sunshine Act (“Sunshine Act”). The Sunshine Act requires, among others, “applicable manufacturers” of drugs, devices, biological products, and medical supplies reimbursed under Medicare, Medicaid or the Children’s Health Insurance Program to annually report to CMS information related to payments and other transfers of value provided to “covered recipients.” The term covered recipients includes teaching hospitals and U.S.-licensed physicians, physician assistants, nurse practitioners, clinical nurse

specialists, certified nurse anesthetists, and certified nurse-midwives. There is the risk that CMS or another government agency may take the position that our products are not human cell and tissue products regulated solely under Section 361, and thereby assert that we are currently subject to the Sunshine Act, which could subject us to civil penalties and the administrative burden of having to comply with the law.

There are state law equivalents to the AKS and FCA. There are also so-called state “all-payer” anti-kickback laws which may apply to items or services reimbursed by any third-party payer, including commercial insurers, as well as when no insurer is involved (i.e. cash-pay patients).

The enforcement of all of these laws is uncertain and subject to rapid change. Federal or state regulatory or enforcement authorities may investigate or challenge our current or future activities under these laws. Any investigation or challenge could have a material adverse effect on our business, financial condition and results of operations. Any state or federal regulatory or enforcement review of us, regardless of the outcome, would be costly and time consuming. Additionally, we cannot predict the impact of any changes in these laws, whether these changes are retroactive or will have effect on a going-forward basis only.

The MACs proposed LCDs for skin substitutes that could reduce or eliminate Medicare coverage for our products, which would have a material adverse effect on utilization of our products, our business and our revenue.

On April 25, 2024, all of the MACs proposed LCDs for skin substitutes that, if finalized, would eliminate Medicare coverage for our products until acceptable peer-reviewed evidence is developed to support coverage. The proposed LCDs would also limit the number of applications of skin substitute products per wound episode. We do not know the timing or outcome of the proposed LCDs and whether they will be finalized by the MACs. If the LCDs are finalized, and we are unable to convince the MACs that we have adequate evidence to support Medicare coverage for our products, or that the MACs should allow an appropriate number of applications of skin substitute products, the LCDs could materially and adversely impact utilization of our products, our business and our revenue.

Our results of operations may be adversely affected by current and potential future healthcare reforms.

In response to perceived increases in healthcare costs in recent years, there have been and continue to be proposals by the U.S. federal government, state governments, regulators and third-party payers to control these costs and, more generally, to reform the U.S. healthcare system. In the U.S., the PPACA was enacted in 2010 with a goal of reducing the cost of healthcare and substantially changing the way healthcare is financed by both government and private insurers.

In addition, other legislative changes have been proposed and adopted in the U.S. since the PPACA was enacted. The Budget Control Act of 2011 created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This included aggregate reductions of Medicare payments to providers of 2% per fiscal year, which went into effect on April 1, 2013. In January 2013, the American Taxpayer Relief Act was signed into law, which, among other things, further reduced Medicare payments to several provider types, including hospitals.

In addition to the ACA, the Medicare Access and CHIP Reauthorization Act of 2015 (“MACRA”) repealed the Sustainable Growth Rate formula used to calculate Medicare payment updates for physicians providing services to Medicare beneficiaries. In its place, MACRA introduced the Quality Payment Program (“QPP”), which is a value-based program that focuses on quality and outcomes as a metric for physician reimbursement. In addition, the PPACA encourages hospitals and physicians to work collaboratively through shared savings programs as well as other bundled payment initiatives. These shifts could lead to a consolidation of hospital providers into larger delivery networks with increased price negotiation strength resulting in downward pressure on our selling prices. Although we believe that we are well positioned to minimize any such impact on our business, our inability to address the consolidation trend could materially and adversely affect our business and results of operations.

There is uncertainty with respect to the impact future legislation or regulation may have, if any, and any changes will likely take time to unfold and could have an impact on coverage and reimbursement for healthcare items and services, including our products. We believe that there is substantial uncertainty over how benefit plans purchased on exchanges will cover our products, how the expansion or contraction of the Medicaid program will affect access to our products, the effect of risk-sharing payment models such as Accountable Care Organizations and other value-based purchasing programs on coverage for our product, and the effect of the general increase or decrease in federal oversight of healthcare payers. The taxes imposed and the expansion in government’s role in the U.S. healthcare industry may result in decreased revenues, lower reimbursements by payers for our products and reduced medical procedure volumes, all of which could have a material adverse effect on our business, results of operations and financial condition.

Federal and state laws that protect the privacy and security of personal information may increase our costs and limit our ability to collect, disclose, and use that information and subject us to liability if we are unable to fully comply with such laws.

Numerous federal and state laws, rules and regulations govern the collection, dissemination, use, security and confidentiality of personal information, including protected health information and individually identifiable health information. These laws include:

Penalties for violations of these laws vary. For instance, penalties for failure to comply with a requirement of HIPAA and the HITECH Act vary significantly, and include civil monetary penalties of up to $2,067,813 per violation, not to exceed $2,067,813 per calendar year for each provision of HIPAA that is violated and, in certain circumstances, criminal penalties with fines up to $250,000 per violation and/or imprisonment. However, a single breach incident can result in findings of violations of multiple provisions, leading to possible penalties in excess of $2,067,813 for violations in a single year. A person who knowingly obtains or discloses individually identifiable health information in violation of HIPAA may face a criminal penalty of up to $50,000 and up to one-year imprisonment. The criminal penalties increase if the wrongful conduct involves false pretenses or the intent to sell, transfer, or use identifiable health information for commercial advantage, personal gain, or malicious harm. In addition, responding to government investigations regarding alleged violations of these and other laws and regulations, even if ultimately concluded with no findings of violations or no penalties imposed, can consume company resources and impact our business and, if public, harm our reputation.

Further, various states, such as California, Massachusetts, and Washington, have implemented similar privacy laws and regulations that impose restrictive requirements regulating the use and disclosure of health information and other personally identifiable information. These laws and regulations are not necessarily preempted by HIPAA, particularly if a state affords greater protection to individuals than HIPAA. Where state laws are more protective, we may have to comply with the stricter provisions. In addition to fines and penalties imposed upon violators, some of these state laws also afford private rights of action to individuals who believe their personal information has been misused. The interplay of federal and state laws may be subject to varying interpretations by courts and government agencies, creating complex compliance issues for us and our customers and potentially exposing us to additional expense, adverse publicity and liability. Further, as regulatory focus on privacy issues continues to increase and laws and regulations concerning the protection of personal information expand and become more complex, these potential risks to our business could intensify. Changes in laws or regulations associated with the enhanced protection of certain types of sensitive data, such as PHI, or personally identifiable information along with increased customer demands for enhanced data security infrastructure, could greatly increase our cost of providing our products, decrease demand for our services, reduce our revenue and/or subject us to additional liabilities.

As part of our business operations, including our medical record keeping, third-party billing and reimbursement and research and development activities, we collect and maintain protected health information in paper and electronic format. Standards related to collecting and maintaining health information, whether implemented pursuant to HIPAA, HITECH, state laws, federal or state action or otherwise, could have a significant effect on the manner in which we handle personal information, including healthcare-related data, and communicate with payers, providers, patients, donors and others, and compliance with these standards could impose significant costs on us or limit our ability to offer services, thereby negatively impacting the business opportunities available to us.

If we are alleged to have not complied with existing or new laws, rules and regulations related to personal information, we could be subject to litigation and to sanctions that include monetary fines, civil or administrative penalties, civil damage awards or criminal penalties.

Risks Related to Our Intellectual Property

Our ability to protect our intellectual property and proprietary technology through patents and other means is uncertain and may be inadequate, which could have an adverse effect on our business, results of operations and financial condition.

Our success depends significantly on our ability to protect our proprietary rights to the technologies used in our products. We rely on patent protection, as well as a combination of copyright, trade secret and trademark laws and nondisclosure, confidentiality and other contractual restrictions to protect our proprietary technology, including our licensed technology. These legal means afford only limited protection and may not adequately protect our rights or permit us to gain or keep any competitive advantage. In addition, our pending patent

applications include claims to material aspects of our products that may not be protected by issued patents. The patent application process can be time consuming and expensive. Our pending patent applications might not result in issued patents, and issued patents may later be determined to be invalid or unenforceable as a result of district court litigation or related administrative proceedings. Competitors may be able to design around our patents or develop products that provide outcomes that are comparable or even superior to ours. Although we have taken steps to protect our intellectual property and proprietary technology, including entering into confidentiality agreements and intellectual property assignment agreements with some of our officers, employees, consultants and advisors, such agreements may not be enforceable or may not provide meaningful protection for our trade secrets or other proprietary information in the event of unauthorized use or disclosure or other breaches of the agreements.

The failure to obtain and maintain patents or protect our intellectual property rights could have an adverse effect on our business, results of operations, and financial condition. Whether a patent claim is valid is a complex matter of science, facts and law, and therefore we cannot be certain that, if challenged in a court of law, or through an administrative proceeding, our patent claims would be upheld. If any of those patent claims are invalidated or determined to be unenforceable, our competitive advantage may be reduced or eliminated.

In the event a competitor infringes upon our licensed patents, issued patents, pending patent applications or other intellectual property rights, enforcing those rights may be costly, uncertain, difficult and time consuming. Even if successful, litigation to enforce or defend our intellectual property rights could be expensive and time consuming and could divert our management’s attention. Further, bringing litigation to enforce our patents subjects us to the potential for counterclaims. Other companies or entities may commence, actions seeking to establish the invalidity of our patents and certain related claims. In the event that any of our patent claims are challenged, a court, the United States Patent and Trademark Office (“USPTO”), or the Patent Trial and Appeal Board (“PTAB”) of the USPTO may invalidate one or more challenged patent claims or determine that the patent is unenforceable, which could harm our competitive position. If the USPTO or the PTAB ultimately cancels or narrows the claim scope of any of our patents through these proceedings, it could prevent or hinder us from being able to enforce them against competitors. Such adverse decisions could negatively impact our business, results of operations, and financial condition.

We may become subject to claims of infringement of the intellectual property rights of others, which could prohibit us from developing our products, require us to obtain licenses from third parties or to develop non-infringing alternatives, and subject us to substantial monetary damages.

Third parties could assert that our products infringe one or more claims of their issued patents or other intellectual property rights. Whether a product infringes a patent claim or other intellectual property right involves a complex combination of legal and factual issues, the determination of which is often uncertain. Therefore, we cannot be certain that we have not infringed the intellectual property rights of others. Because patent applications are not immediately published, and may take years to issue, there also may be applications now pending of which we are unaware that may later result in issued patent claims that our products or processes may infringe. There also may be existing patents or pending patent applications of which we are unaware that our products or processes may inadvertently infringe.

Any infringement claim could cause us to incur significant costs, place significant strain on our financial resources, divert management’s attention from our business and harm our reputation. If the relevant patent claims at issue in such a dispute were upheld as valid and enforceable and we were found to infringe, we could be prohibited from selling any product that is found to infringe those claims through an injunction unless we could obtain licenses to use the technology covered by the asserted patent claims or other intellectual property, or are able to design around the patent claim or claims at issue or other intellectual property. We may be unable to obtain such a license on terms acceptable to us, if at all, and we may not be able to redesign our products to avoid infringement. A court could also order us to pay compensatory damages for such infringement, plus prejudgment interest and could, in addition, treble the compensatory damages and award attorney fees. These damages could be substantial and could harm our reputation, business, financial condition and operating results. A court also could enter orders that temporarily, preliminarily or permanently enjoin us and our customers from making, using, or selling products, and could enter an order mandating that we undertake certain remedial measures. Depending on the nature of the relief ordered by the court, we could become liable for additional damages to third parties. Further, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our trade secrets or other confidential information could be compromised by inadvertent or court-ordered disclosure during this type of litigation.

We may be subject to damages resulting from claims that we, our employees, or our independent contractors have wrongfully used or disclosed alleged trade secrets, proprietary or confidential information of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors.

We may hire additional employees who are currently employed at other tissue companies, including our competitors. Additionally, consultants or other independent agents with which we may contract may be or have been in a contractual arrangement with one or more of our competitors. Although no claims are currently pending, we may be subject to claims that we, our employees, or our independent contractors have inadvertently or otherwise used or disclosed trade secrets or other proprietary information of these former employers or competitors. In addition, we have been and may in the future be subject to claims that we caused an employee to breach the terms of his or her non-competition or non-solicitation agreement. Litigation may be necessary to defend against these claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to management. If we fail to defend such

claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Any future litigation or the threat thereof may adversely affect our ability to hire additional direct sales representatives. A loss of key personnel or their work product could hamper or prevent our ability to market existing or new products, which could severely harm our business, financial condition and operating results.

Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

Success in the biopharmaceutical industry is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the biopharmaceutical industry involve both technological and legal complexity, and therefore obtaining and enforcing biopharmaceutical patents is costly, time-consuming and inherently uncertain.

Recent patent reform legislation could increase the uncertainties and costs of prosecuting patent applications and enforcing and defending patents. Enacted in 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, made significant changes to U.S. patent law, including provisions that affect the prosecution of patent applications and also affect patent litigation. The U.S. Patent and Trademark Office developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, including the first to file provisions, only became effective in March 2013. The full impact of the Leahy-Smith Act on our business is not yet clear, but it could result in increased costs and more limited patent protection, either of which could adversely affect our business, results of operations and financial condition.

Moreover, recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. In addition to increasing uncertainty regarding our ability to obtain patents in the future, this combination of events has created uncertainty regarding the value of any patents we do obtain. Depending on decisions by the U.S. Congress, the federal courts, and the U.S. Patent and Trademark Office, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce any current or future patents that we may own or license.

Risks Related to our Common Stock

Even if our common stock is listed on Nasdaq, there can be no assurance that we will be able to comply with Nasdaq’s continued listing standards.

We have applied to list our common stock on The Nasdaq Capital Market under the symbol “BSEM”. We cannot guarantee that we will be successful in listing our common stock on Nasdaq, and our common stock may continue to trade on the Pink tier of the OTC Marketplace under the symbol “BSEM.”

Assuming that our common stock is listed, there can be no assurance any broker will be interested in trading our common stock. Therefore, it may be difficult to sell your common stock if you desire or need to sell them. We cannot provide any assurance that an active and liquid trading market in our common stock will develop or, if developed, that such market will continue. Once our common stock is approved for listing on Nasdaq, there is no guarantee that we will be able to maintain such listing for any period of time by perpetually satisfying Nasdaq’s continued listing requirements. Our failure to continue to meet these requirements may result in our common stock being delisted from Nasdaq.

We will incur significant costs as a result of operating as a public company and our management expects to devote substantial time to public company compliance programs.

As a public company, we will incur significant legal, accounting and other expenses due to our compliance with regulations and disclosure obligations applicable to us, including compliance with the Sarbanes-Oxley Act, as well as rules implemented by the SEC and Nasdaq. Shareholder activism, the current political environment and the current high level of government intervention and regulatory reform may lead to substantial new regulations and disclosure obligations, which may lead to additional compliance costs and impact, in ways we cannot currently anticipate, the manner in which we operate our business. Our management and other personnel will devote a substantial amount of time to these compliance programs and monitoring of public company reporting obligations and as a result of the new corporate governance and executive compensation related rules, regulations and guidelines prompted by the Dodd-Frank Act and further regulations and disclosure obligations expected in the future, we will likely need to devote additional time and costs to comply with such compliance programs and rules. These rules and regulations will cause us to incur significant legal and financial compliance costs and will make some activities more time-consuming and costly.

To comply with the requirements of being a public company, we may need to undertake various actions, including implementing new internal controls and procedures and hiring new accounting or internal audit staff. The Sarbanes-Oxley Act requires that we maintain effective disclosure controls and procedures and internal control over financial reporting. We are continuing to develop and refine our disclosure controls and other procedures that are designed to ensure that information required to be disclosed by us in the reports that we file with the SEC is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that

information required to be disclosed in reports under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), is accumulated and communicated to our principal executive and financial officers. Our current controls and any new controls that we develop may become inadequate and weaknesses in our internal control over financial reporting may be discovered in the future. As discussed below, our auditors identified material weaknesses in our financial reporting during our audits for the years ended December 31, 2023 and 2022. The Company is currently working on remediating these weaknesses in our financial reporting by expanding our internal accounting resources and engaging outside consultants, as needed, to remediate such weaknesses.

Any failure to develop or maintain effective controls when we become subject to this requirement could negatively impact the results of periodic management evaluations and annual independent registered public accounting firm attestation reports regarding the effectiveness of our internal control over financial reporting that we may be required to include in our periodic reports we will file with the SEC under Section 404 of the Sarbanes-Oxley Act of 2002 (the “Sarbanes-Oxley Act”), harm our operating results, cause us to fail to meet our reporting obligations or result in a restatement of our prior period financial statements. In the event that we are not able to demonstrate compliance with the Sarbanes-Oxley Act, that our internal control over financial reporting is perceived as inadequate or that we are unable to produce timely or accurate financial statements, investors may lose confidence in our operating results and the price of our common stock could decline. In addition, if we are unable to continue to meet these requirements, we may not be able to remain listed on Nasdaq.

The elimination of monetary liability against our directors, officers and employees under our Amended and Restated Articles of Incorporation and the existence of indemnification rights to our directors, officers and employees may result in substantial expenditures by us and may discourage lawsuits against our directors, officers and employees.

Our Amended and Restated Articles of Incorporation contain provisions that eliminate the liability of our directors for monetary damages to us and our shareholders. Our Amended and Restated Bylaws also require us to indemnify our officers and directors. We may also have contractual indemnification obligations under our agreements with our directors, officers and employees. The foregoing indemnification obligations could result in us incurring substantial expenditures to cover the cost of settlement or damage awards against directors, officers and employees that we may be unable to recoup. These provisions and resulting costs may also discourage our shareholders from bringing a lawsuit against directors, officers and employees for breaches of their fiduciary duties, and may similarly discourage the filing of derivative litigation by our shareholders against our directors, officers and employees even though such actions, if successful, might otherwise benefit us and our shareholders.

If we fail to maintain an effective system of internal controls, we may not be able to accurately report our financial results or prevent fraud which could subject us to regulatory sanctions, harm our business and operating results and cause the trading price of our stock to decline.

Effective internal controls required under Section 404 of the Sarbanes-Oxley Act are necessary for us to provide reliable financial reports and effectively prevent fraud. If we cannot provide reliable financial reports or prevent fraud, our business, reputation and operating results could be harmed. We have discovered, and may in the future discover, areas of our internal controls that need improvement. We cannot be certain that the measures we have taken or intend to take will ensure that we maintain adequate controls over our financial processes and reporting in the future. Any failure to implement required new or improved controls or difficulties encountered in their implementation could subject us to regulatory sanctions, harm our business and operating results or cause us to fail to meet our reporting obligations. Inferior internal controls could also harm our reputation and cause investors to lose confidence in our reported financial information, which could have a negative impact on the trading price of our stock.

We are an “emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies could make our common stock less attractive to investors.

As a company with less than $1.235 billion in revenues during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act enacted in 2012 (the “JOBS Act”). Emerging growth companies may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and shareholder approval of any golden parachute payments not previously approved. Investors could find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

In addition, Section 102 of the JOBS Act also provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. An “emerging growth company” can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies.

We are a “smaller reporting company”, and the reduced reporting requirements applicable to smaller reporting companies may make our common stock less attractive to investors.

We are a “smaller reporting company” as defined in Rule 12b-2 under the Exchange Act. For as long as we continue to be a smaller reporting company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not smaller reporting companies, including reduced financial statement and other financial information disclosure, and reduced disclosure obligations regarding executive compensation in our annual and periodic reports and proxy statements. We will remain a smaller reporting company as long as either (i) the market value of our common stock held by non-affiliates is less than $250 million or (ii) our annual revenue is less than $100 million during the most recently completed fiscal year and the market value of our common stock held by non-affiliates is less than $700 million. Our public float is measured as of the last business day of our most recently completed second fiscal quarter, and annual revenues are as of the most recently completed fiscal year for which audited financial statements are available. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our share price may be more volatile than that of an otherwise comparable company that does not avail itself of the same or similar exemptions.

Raising additional capital may cause dilution to our existing shareholders and restrict our operations.

We may seek additional capital through a combination of public and private equity offerings and debt financings. We, and indirectly, our shareholders, will bear the cost of issuing and servicing such securities. Because our decision to issue debt or equity securities in any future offering will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing, or nature of any future offerings. To the extent that we raise additional capital through the sale of equity or debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a shareholder. The incurrence of indebtedness would result in increased fixed payment obligations and could involve restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell, or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business.

Our common stock price may be volatile and could fluctuate, which could result in substantial losses for investors.

Our common stock is currently quoted on the OTC Pink under the symbol, “BSEM.” The market price of our common stock is likely to be highly volatile and could fluctuate widely in price in response to various factors, many of which are beyond our control, including:

You should consider any one of these factors to be material. Our stock price may fluctuate widely as a result of any of the above.

In addition, the securities markets have from time-to-time experienced significant price and volume fluctuations that are unrelated to the operating performance of particular companies. These market fluctuations may also materially and adversely affect the market price of our common stock.

We identified material weaknesses in our internal control over financial reporting. If we are unable to remediate these material weaknesses, or if we identify additional material weaknesses in the future or otherwise fails to maintain effective internal control over financial reporting, we may not be able to accurately or timely report our financial condition or results of operations, which may adversely affect our business and share price.

A material weakness is a deficiency, or combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the annual or interim financial statements will not be prevented or detected on a timely basis. As of and for the years ended December 31, 2023 and 2022, the material weaknesses are as follows:

These material weaknesses resulted in adjustments related to inventory, equity-based compensation and accruals for the years ended December 31, 2022 and 2023.

Additionally, these material weaknesses could result in a misstatement of substantially all of our accounts or disclosures that would result in a material misstatement to the annual or interim financial statements that would not be prevented or detected. We have begun implementation of a plan to remediate the material weaknesses, which will result in significant future costs for the Company.

We are working to remediate the material weaknesses as efficiently and effectively as possible. At this time, we cannot provide an estimate of costs expected to be incurred in connection with implementing this remediation plan; however, these remediation measures will be time consuming, will result in us incurring significant costs and will place significant demands on its financial and operational resources.

While we are designing and implementing measures to remediate its existing material weaknesses, we cannot predict the success of such measures or the outcome of its assessment of these measures at this time. We can give no assurance that these measures will remediate any of the deficiencies in its internal control over financial reporting, or additional material weaknesses in its internal control over financial reporting will not be identified in the future. Our current controls and any new controls that it develops may become inadequate because of changes in conditions in its business, personnel, IT systems and applications, or other factors. Any failure to design or maintain effective internal control over financial reporting or any difficulties encountered in their implementation or improvement could increase compliance costs, negatively impact share trading prices, or otherwise harm our operating results or cause it to fail to meet its reporting obligations. The effectiveness of our internal control over financial reporting is subject to various inherent limitations, including cost limitations, judgments used in decision making, assumptions about the likelihood of future events, the possibility of human error and the risk of fraud. If we are unable to remediate the material weaknesses, our ability to record, process, summarize and report information within the time periods specified in the rules and forms of the SEC could be adversely affected, which, in turn, may adversely affect our reputation and business and the market price of our common stock. In addition, any such failures could result in litigation or regulatory actions by the Securities and Exchange Commission (the “SEC”) or other regulatory authorities, loss of investor confidence and harm to our reputation and financial condition, or diversion of financial and management resources from the operation of our business.

As a public company, we will be required, pursuant to Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of its internal control over financial reporting. our independent registered public accounting firm is not required to attest to the effectiveness of our internal control over financial reporting until after we are no longer an “emerging growth company,” as defined in the JOBS Act, or a “smaller reporting company,” as defined in Item 10(f)(1) of Regulation S-K. We may not be able to conclude on an ongoing basis that we have effective internal control over financial reporting, in which case our independent registered public accounting firm could not issue an unqualified opinion related to the effectiveness of our internal control over financial reporting. If we are unable to conclude that we have effective internal control over financial reporting and our independent registered public accounting firm is unable to issue an unqualified opinion related to the effectiveness of our internal control over financial reporting, investors could lose confidence in our reported financial information, which could have a material adverse effect on the trading price of our common stock.

If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, the price of the common stock and trading volume could decline.

The trading market for the common stock depends in part on the research and reports that securities or industry analysts publish about us or our business. If few or no securities or industry analysts cover us, the trading price for the common stock would be negatively impacted. If one or more of the analysts who covers us downgrades the common stock, publishes incorrect or unfavorable research about

our business, ceases coverage of us, or fails to publish reports on us regularly, demand for the common stock could decrease, which could cause the price of the common stock or trading volume to decline.

Fluctuations in revenue or results of operations could cause additional volatility in our stock price.

Any unanticipated shortfall in our revenue in any fiscal quarter could have an adverse effect on our results of operations in that quarter. The effect on our net income of such a shortfall could be exacerbated by the relatively fixed nature of most of our costs, which primarily include personnel costs as well as facilities costs. These fluctuations could cause the trading price of our stock to be negatively affected. Our quarterly operating results have varied substantially in the past and may vary substantially in the future.

Certain provisions of Florida law and anti-takeover provisions in our organizational documents may discourage or prevent a change of control, even if an acquisition would be beneficial to shareholders, which could affect our share price adversely and prevent attempts by shareholders to remove current management.

The Florida Business Corporation Act (the “FBCA”) includes several provisions applicable to us that may discourage potential acquirors. Such provisions include provisions that:

Additionally, our organizational documents contain provisions:

These provisions of Florida law and our Amended and Restated Articles of Incorporation and Amended and Restated Bylaws could negatively affect our share price, prevent attempts by shareholders to remove current management, prohibit or delay mergers or other takeovers or changes of control of us and discourage attempts by other companies to acquire us, even if such a transaction would be beneficial to our shareholders.

If the voting power of our capital stock continues to be highly concentrated, it may prevent you and other minority shareholders from influencing significant corporate decisions and may result in conflicts of interest.

As of the date of this Form 10 Registration Statement, Jason Matuszewski, our Chief Executive Officer and Director, Andrew Van Vurst, our Chief Operating Officer and Director, and Henry Van Vurst, a greater than 5% shareholder and father of Andrew Van Vurst, each hold 100 Series A-1 Convertible Preferred Shares, which as a group grants them effective control of us. The Series A-1 Convertible Preferred Shares entitle their holders to a number of votes equal to the number of shares issuable upon conversion times 2,000,000 granting the holders of Series A-1 Convertible Preferred Shares, as a group, effective control of us. If the holders of the Series A-1 Convertible Preferred Shares were to vote together, they would hold effectively 100% of the voting power of us. The Series A-1 Convertible Preferred Shares are convertible, at the option of the holders, or automatically upon a public offering resulting in gross proceeds to us of not less than $30 million, in whole but not in part, into 300 shares of common stock. As a result, management will have majority voting power over all matters requiring shareholder votes, including: the election of directors; mergers, consolidations and acquisitions; the sale of all or substantially all of our assets and other decisions affecting our capital structure; amendments to our Amended and Restated Articles of Incorporation or our Amended and Restated Bylaws; and our winding up and dissolution.

This concentration of voting power may delay, deter or prevent acts that would be favored by our other shareholders. The interests of management may not always coincide with our interests or the interests of our other shareholders. This concentration of voting power may also have the effect of delaying, preventing or deterring a change in control of us. Also, management may seek to cause us to take courses of action that, in their judgment, could enhance their investment in us, but which might involve risks to our other shareholders or adversely affect us or our other shareholders. As a result, the market price of our common stock could decline or shareholders might not

receive a premium over then-current market price of our common stock upon a change in control. In addition, this concentration of voting power may adversely affect the trading price of our common stock because investors may perceive disadvantages in owning shares in a company with significant shareholders.

We will be a “controlled company” within the meaning of Nasdaq listing standards and, as a result, will qualify for exemptions from certain corporate governance requirements. You may not have the same protections afforded to shareholders of companies that are subject to such requirements.

Through the Series A-1 Convertible Preferred Shares, as a group, Jason Matuszewski, our Chief Executive Officer and Director, Andrew Van Vurst, our Chief Operating Officer and Director, and Henry Van Vurst have effective control of the Company. Accordingly, we will be a “controlled company” within the meaning of Nasdaq listing standards and, as a result, will qualify for, and may rely on, exemptions from certain corporate governance requirements. You may not have the same protections afforded to shareholders of companies that are subject to such requirements.

Because we will be considered a “controlled company” for the purposes of Nasdaq listing rules, we will qualify for, and may rely on, exemptions from certain corporate governance requirements, including that a majority of the company consist of “independent directors,” as defined under Nasdaq listing rules. In addition, we will not be required to have a nominating and corporate governance committee or compensation committee that is composed entirely of independent directors with written charters addressing the committees’ purposes and responsibilities and an annual performance evaluation of these committees.

If at any time we cease to be a “controlled company” under Nasdaq listing rules, we intend to take any action that may be necessary to comply with Nasdaq listing rules, subject to a permitted “phase-in” period. These and any other actions necessary to achieve compliance with such rules may increase our legal and administrative costs, will make some activities more difficult, time-consuming and costly and may also place additional strain on our personnel, systems and resources.

Our common stock may be subject to the “penny stock” rules in the future. It may be more difficult to resell securities classified as “penny stock.”

Our common stock may be subject to “penny stock” rules (generally defined as non-exchange traded stock with a per-share price below $5.00) in the future. While our common stock will not be considered “penny stock” assuming we are successful in having them listed on Nasdaq, if we are unable to maintain that listing and our common stock is no longer listed on Nasdaq, unless we maintain a per-share price above $5.00, our common stock will become “penny stock.” These rules impose additional sales practice requirements on broker-dealers that recommend the purchase or sale of penny stocks to persons other than those who qualify as “established customers” or “accredited investors.” For example, broker-dealers must determine the appropriateness for non-qualifying persons of investments in penny stocks. Broker-dealers must also provide, prior to a transaction in a penny stock not otherwise exempt from the rules, a standardized risk disclosure document that provides information about penny stocks and the risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, disclose the compensation of the broker-dealer and its salesperson in the transaction, furnish monthly account statements showing the market value of each penny stock held in the customer’s account, provide a special written determination that the penny stock is a suitable investment for the purchaser, and receive the purchaser’s written agreement to the transaction.

Legal remedies available to an investor in “penny stocks” may include the following:

These requirements may have the effect of reducing the level of trading activity, if any, in the secondary market for a security that becomes subject to the penny stock rules. The additional burdens imposed upon broker-dealers by such requirements may discourage broker-dealers from effecting transactions in our securities, which could severely limit the market price and liquidity of our securities. These requirements may restrict the ability of broker-dealers to sell our common stock and may affect your ability to resell our common stock.

Many brokerage firms will discourage or refrain from recommending investments in penny stocks. Most institutional investors will not invest in penny stocks. In addition, many individual investors will not invest in penny stocks due, among other reasons, to the increased financial risk generally associated with these investments.

For these reasons, penny stocks may have a limited market and, consequently, limited liquidity. We can give no assurance at what time, if ever, our common stock will not be classified as a “penny stock” in the future.

If the benefits of any proposed acquisition do not meet the expectations of investors, shareholders or financial analysts, the market price of our common stock may decline.

If the benefits of any proposed acquisition do not meet the expectations of investors or securities analysts, the market price of our common stock prior to the closing of the proposed acquisition may decline. The market values of our common stock at the time of the proposed acquisition may vary significantly from their prices on the date the acquisition target was identified.

In addition, broad market and industry factors may materially harm the market price of our common stock irrespective of our operating performance. The stock market in general has experienced price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of the particular companies affected. The trading prices and valuations of these stocks, and of our securities, may not be predictable. A loss of investor confidence in the market for retail stocks or the stocks of other companies which investors perceive to be similar to us could depress our stock price regardless of our business, prospects, financial conditions or results of operations. A decline in the market price of our securities also could adversely affect our ability to issue additional securities and our ability to obtain additional financing in the future.

Sales of a substantial number of our common stock in the public markets by our existing shareholders in the future could cause the price of the common stock to fall.

Sales of a substantial number of our common stock in the public market in the future or the perception that these sales might occur, could depress the market price of the common stock and could impair our ability to raise capital through the sale of additional equity securities from time to time. We are unable to predict the effect that any such sales may have on the prevailing market price of the common stock.

We have never declared or paid any cash dividends or distributions on our capital stock, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future.

We have never declared or paid any cash dividends or distributions on our capital stock. We currently intend to retain our future earnings, if any, to support operations and to finance expansion and therefore we do not anticipate paying any cash dividends on our common stock in the foreseeable future.

The declaration, payment and amount of any future dividends will be made at the discretion of the board of directors, and will depend upon, among other things, the results of our operations, cash flows and financial condition, operating and capital requirements, contractual limitations under future credit facilities and other factors as the board of directors considers relevant. There is no assurance that future dividends will be paid, and, if dividends are paid, there is no assurance with respect to the amount of any such dividend.

We may become involved in securities class action litigation that could divert management’s attention and harm our business.

The stock market in general, and the shares of emerging growth companies in particular, have experienced extreme price and volume fluctuations. These fluctuations have often been unrelated or disproportionate to the operating performance of the companies involved. If these fluctuations occur in the future, the market price of our shares could fall regardless of our operating performance. In the past, following periods of volatility in the market price of a particular company’s securities, securities class action litigation has often been brought against that company. If the market price or volume of our shares suffers extreme fluctuations, then we may become involved in this type of litigation, which would be expensive and divert management’s attention and resources from managing our business.

As a public company, we may also from time to time make forward-looking statements about future operating results and provide some financial guidance to the public markets. Projections may not be made timely or set at expected performance levels and could materially affect the price of our shares. Any failure to meet published forward-looking statements that adversely affect the stock price could result in losses to investors, shareholder lawsuits or other litigation, sanctions or restrictions issued by the SEC.

Our Amended and Restated Articles of Incorporation and Amended and Restated Bylaws provide that the state and federal courts of the State of Florida will be the sole and exclusive forum for substantially all disputes between us and our shareholders, which could limit our shareholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or other employees.

Article XIX our Amended and Restated Articles of Incorporation, and Section 7.4 of our Amended and Restated Bylaws, provide that, unless we consent in writing to the selection of an alternative forum, the state and federal courts of the State of Florida will be the sole and exclusive forum for (i) any derivative action or proceeding brought on behalf of us, (ii) any action asserting a claim of breach of a fiduciary duty owed by any director, officer or other employee of ours to us or our shareholders, (iii) an action asserting a claim arising pursuant to any provision of the Florida Business Corporation Act, or (iv) any action asserting a claim governed by the internal affairs

doctrine. Additionally, pursuant to Article XIX our Amended and Restated Articles of Incorporation and Section 7.4 of our Amended and Restated Bylaws, the prevailing parties of any such actions will be entitled to recover from the other party reasonable attorneys’ fees, costs and expenses incurred in connection with the prosecution or defense of such action. However, these forum clauses will not apply to claims which are vested in the exclusive jurisdiction of a court or forum other than state and federal courts in the State of Florida. For instance, these exclusive forum provisions will not apply to actions arising under federal securities laws, including suits brought to enforce any liability or duty created by the Securities Act, the Exchange Act, or the rules and regulations thereunder. These provisions will not apply to suits brought to enforce a duty or liability created by the Exchange Act. It is possible that a court of law could rule that choice of forum provision is inapplicable or unenforceable if challenged in a proceeding or otherwise. Therefore, these exclusive forum provisions will not relieve us of our duty to comply with the federal securities laws and the rules and regulations thereunder, and our shareholders will not be deemed to have waived our compliance with these laws, rules and regulations.

These exclusive forum provisions may limit a shareholder’s ability to bring a claim in a judicial forum of its choosing for disputes with us or our directors, officers or other employees, which may discourage lawsuits against us or our directors, officers or other employees. In addition, shareholders who do bring a claim in the state or federal court in the State of Florida could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near Florida. The state or federal court of the State of Florida may also reach different judgments or results than would other courts, including courts where a shareholder would otherwise choose to bring the action, and such judgments or results may be more favorable to us than to our shareholders. However, the enforceability of similar exclusive forum provisions in other companies’ articles of incorporation and bylaws have been challenged in legal proceedings, and it is possible that a court could find these types of provisions to be inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings. If a court were to find the exclusive forum provision to be inapplicable or unenforceable in an action, we might incur additional costs associated with resolving such action in other jurisdictions.

Item 2. Financial Information

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following management’s discussion and analysis of financial condition and results of operations is intended to provide information necessary to understand our audited consolidated financial statements for the years ended December 31, 2023 and 2022 and unaudited financial statements for the three and six months ended June 30, 2024 and 2023, and highlight certain other information which, in the opinion of management, will enhance a reader’s understanding of our financial condition, changes in financial condition and results of operations.

The following discussion and analysis of our results of operations and financial condition should be read in conjunction with our financial statements and the notes to those financial statements that are included elsewhere in this Form 10. Our discussion includes forward-looking statements based upon current expectations that involve risks and uncertainties, such as our plans, objectives, expectations and intentions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of a number of factors. See “Cautionary Note Regarding Forward-Looking Statements” at the beginning of this Form 10.

Overview

We aim to be the leader in regenerative medicine focused on the development, manufacture, and commercialization of placental-derived allografts for advanced wound care. Our mission is to change patients’ lives for the better with the power of superior processes and an unwavering commitment to innovation, quality and superior outcomes.

Prior to 2018, our business was focused on research and development efforts primarily focused on the development of regenerative medicine products. Since 2018, upon our acquisition of Vera, our primary business became the development, manufacture, and distribution of tissue allografts for the advanced wound care market with a focus on the treatment of diabetic ulcers, pressure ulcers and venous ulcers. We market and distribute products directly to medical professionals, such as podiatrists and plastic surgeons, through direct and indirect sales forces and indirectly through distributors. Today, our products are comprised solely of placenta-derived allografts (which are human tissues that are derived by one person and used to treat multiple other persons) but we intend to expand our portfolio of products across the continuum of advanced wound care.

Leveraging our proprietary BioREtain processing method, we manufacture perinatal tissue allografts at the highest levels of quality. BioREtain has been developed by applying the latest research in tissue processing technology, focused on maintaining natural growth factors and preserving tissue structure.

Our allografts, including VENDAJE, VENDAJE AC, VENDAJE OPTIC and AmnioWrap2 are trusted by top clinicians across a range of specialties. Our wound covering products have been shown through clinical and scientific studies to support tissue healing of chronic and hard-to-heal wounds and improve patient outcomes.

The quality of our allografts is essential to our success. Our lab is accredited by the AATB accredited and meets the FDA and cGTP requirements. We strive to provide products and services which not only meet but exceed, CGTP requirements. VENDAJE, VENDAJE AC, AmnioWrap2, and VENDAJE OPTIC are perinatal tissue-derived allografts.

Key Factors Affecting Our Business and Operating Results

Market Trends

According to Allied Market Research, the global advanced wound care market size was valued at $10.3 billion in 2022, and is projected to reach $17.8 billion by 2032, growing at a CAGR of 5.6% from 2023 to 2032. The growth of the advanced wound care market is driven by a rise in adoption of evidence-based treatments for chronic wounds, wide availability of advanced therapy devices and rapid increase in the geriatric population. Moreover, the increase in prevalence of chronic diseases such as diabetes and obesity and rise in disposable income in developing economies fuel the adoption of advanced wound care therapies. For instance, according to the National Diabetes Statistics Report for 2022 by Centers for Disease Control and Prevention ("CDC"), in 2022, about 37.3 million people were estimated to suffer from diabetes in the U.S. As the number of people with diabetes continues to grow, so does the risk of developing diabetic foot ulcers, leading to higher demand for effective treatment options.

The prevalence of both acute and chronic wounds has grown not only in the U.S., but also globally. According to Grand View Research, the global wound care dressing market was valued at $14.20 billion in 2023 and is projected to grow at a CAGR of 4.16% from 2024 to 2030. The increasing prevalence of diverse wounds, including pressure ulcers and surgical site wounds, coupled with a growing aging population and a rise in traumatic accidents globally, is anticipated to drive the growth of the market.

We believe that we will benefit from the expected growth of the global advanced wound care market. Through our in-house manufacturing capabilities and knowledge of navigation the complex regulatory environment, we believe we are well positioned to capture the significant potential growth in the advanced wound care market.

On September 8, 2023, we entered into the Distribution Agreement with the Distributor for the distribution of our AW2 product. During the year ended December 31, 2023, revenues earned from the sale of AW2 under the Distribution Agreement were $13,625,947. During the three and six months ended June 30, 2024, revenues earned from the sale of AW2 under the Distribution Agreement were $74,423,600 and $115,558,500, respectively. As of June 30, 2024 and December 31, 2023, accounts receivable due under this arrangement were $78,073,127 and $11,126,598, respectively. We reported net income for the first time on a US GAAP basis for the three and six months ended June 30, 2024. We had net income of $6,286,028 and $9,543,420 for the three and six months ended June 30, 2024, respectively, as compared to a net loss of $2,855,026 and $6,435,114, for the three and six months ended June 30, 2023, respectively.

In August 2023, three MACs published changes to their Local Coverage Determinations (“LCDs”) that were intended to go into effect on October 1, 2023, before ultimately being abandoned. These LCDs included language that would have lowered the number of allowed applications of a product below what is commonly used in standard practice by physicians today (supported by clinical evidence) and reflected by LCDs currently in force with the MACs. Additionally, the LCDs outlined those skin substitute products which would explicitly be eligible for coverage and those which would not. While these LCDs ultimately were not implemented, the MACs have indicated plans to bring forth a new proposed LCD for skin substitutes in the future, which could include elements that could be unfavorable to our business.

On April 25, 2024, all seven MACs released a proposed LCD which includes language that would require published, peer reviewed evidence supporting evidence supporting their use of as adjunctive treatment. Products not meeting this criteria would potentially be removed from the allowable products list. Currently, management cannot determine the timing of when, if any, decision will be made on the proposed LCD.

Components of our Results of Operations

Revenue, Net

Our revenue, net is derived from selling our products to customers, including sales to distributors, private physician offices, wound care centers, hospital inpatient and outpatient settings, nursing homes and federal facilities, whose medical professionals use our products to treat patients with advanced wound care. These customers choose advanced wound care products based upon a variety of factors, including product efficacy, ease of product use, price, availability of coverage and adequate third-party reimbursement. We recognize revenue, net from product sales at a point in time when control of our product has transferred to the customer, which generally occurs upon shipment. Shipping and handling costs are included as a component of revenue and are passed through to customers with an equal offsetting amount included in cost of goods sold. Revenue, net is recognized in an amount that reflects the consideration that we expect to receive in exchange for the product, net of discounts. Based on prior experience, and the nature of the product, variable consideration resulting from product discounts is not material. Returns from customers are not accepted. Accordingly, there is no provision for sales returns recorded for any period presented.

Costs of Goods Sold

Cost of goods sold represents costs directly related to the production of our products. Products sold are typically shipped directly to the customer with costs associated with shipping and handling included as a component of cost of goods sold. Costs associated with any inventory write-downs resulting from quarterly physical inventory counts are also included within cost of goods sold.

Cost of goods sold includes product testing costs, quality assurance costs, personnel costs, manufacturing costs, raw materials and product costs, depreciation and facility costs associated with our manufacturing and warehouse facilities. Fluctuations in our cost of goods sold correspond with the fluctuations in these costs as well as sales volume.

Gross Profit

Gross profit is calculated as revenue, net less cost of goods sold. Gross margin is calculated as gross profit divided by revenue, net. Our gross margin is affected by product and geographic sales mix, realized pricing of our products, the efficiency of our manufacturing operations and the costs of materials used to make our products. Regulatory actions, including with respect to reimbursement for our products, may require costly expenditures or result in pricing pressure, and may decrease our gross profit and gross margin.

Sales and Marketing Expenses

Sales and marketing expenses consist primarily of BFSF paid under the Distribution Agreement, advertising, sales and marketing personnel, strategic and digital marketing, and trade show expenses. Pursuant to the Distribution Agreement, the Distributor invoices us monthly for BFSF.

The BFSF is consideration payable to the Distributor for a distinct service the Distributor is providing to us. In accordance with ASC 606-10-32-26, such distinct services provided by a customer are accounted for in the same way that other purchases from suppliers would be accounted for. If the amount of consideration payable to the customer exceeds the fair value of the distinct good or service that the entity receives from the customer, then the entity shall account for such an excess as a reduction of the transaction price. We have determined that the fair value of the BFSF does not exceed the consideration paid to the Distributor for these services. Therefore, we record, as revenue, the sales price per cm2 for all AW2 products sold to the Distributor upon shipment and recognize the BFSF as an operating expense within sales and marketing expenses.

General, Administrative & Other Expenses

General, administrative and other expenses consist mainly of payroll expenses, share-based compensation, legal and professional fees and general office expenses.

Research and Development Expenses

Research and development expenses include payroll expenses for our research and development personnel, expenses related to improvements in our manufacturing processes, enhancements to our currently available products, and additional investments in our product and platform development pipeline. Our research and development expenses also include expenses for clinical trials. We expense research and development expenses as incurred. We generally expect that research and development expenses will increase as we continue to conduct clinical trials on new and existing products, move products through the regulatory pathway, bring new products to market, and enhance our manufacturing process and procedures.

Revenues, net

We earned revenues, net of $74,491,996 for the three months ended June 30, 2024, as compared with $1,068,400 for the three months ended June 30, 2023, an increase of $73,423,596. The increase in revenue, net was primarily due to revenue earned from the Distribution Agreement with the Distributor, which was driven by the continued successful commercial acceptance into the post-acute setting of AmnioWrap2.

Cost of Goods Sold

For the three months ended June 30, 2024 and 2023, costs of goods sold were $3,747,896 and $206,104, respectively, an increase of $3,541,792. The increase was primarily attributable to an increase in licensing fees from accelerated production sales of AmnioWrap2 in 2024.

Gross Profit and Gross Profit Margin

For the three months ended June 30, 2024 and 2023, our gross profit was $70,744,100 and $862,296, respectively, an increase of $69,881,804. This increase is attributed to revenue earned from the sales of AmnioWrap2.

For the three months ended June 30, 2024 and 2023, our gross profit margin was 95% and 81%, respectively. The increase in gross profit margin is due to the sale of our lower cost AmnioWrap2 product in 2024 and from manufacturing efficiencies obtained during 2024.

Sales and Marketing Expenses

For the three months ended June 30, 2024, sales and marketing expenses were $58,997,880 and $590,975, respectively, an increase of $58,406,905. The increase year over year is almost all attributable to BFSF expenses of $57,952,327 due to Venture Medical, the distributor of our AmniWrap2 product. The remaining incremental increase in expense of $454,578 is attributable to increases in sales commissions, general marketing expenses and credit loss expenses.

General and Administrative Expenses

For the three months ended June 30, 2024 and 2023, general and administrative expenses were $2,787,822 and $2,863,787, respectively, a decrease of $75,965, and consisted mainly of payroll related expenses and share-based compensation. The decrease period over period results from the three months ended June 30, 2023 including $720,500 for a legal settlement offset by an increase in payroll and related expenses as we began increasing headcount in the end of 2023 and first quarter of 2024 due to overall Company growth.

Research & Development

Our research and development expenses for the three months ended June 30, 2024 were $85,154 as compared to $60,904, respectively, an increase of $24,250 for the three months ended June 30, 2023. The increase in research and development expenses period over period are due to additional expenses incurred in the second quarter of 2024 related the extension of expiration dates on certain products.

Total Operating Expenses

For the three months ended June 30, 2024 and 2023, we incurred total operating expenses of $61,924,969 and $3,575,684, respectively, an increase of $58,349,285 year over year. The increase is primarily attributed to increased BFSF related to the Distribution

Agreement with Venture Medical, our Distributor of AmnioWrap2, which was $57,952,327 of the $58,349,285 incremental expense period over period.

Other Expense, net

For the three months ended June 30, 2024 and 2023, we realized other expense, net of $219,166 and $141,638, respectively. This represents an increase of $77,528. This increase is attributed to the amortization of a debt discount associated with a promissory note executed in June 1, 2023 with a warrant with a relative fair value of $305,310 which is being amortized over a two year period.

Revenues, net

We earned revenues, net of $116,396,209 for the six months ended June 30, 2024, as compared with $1,644,503 for the six months ended June 30, 2023, an increase of $114,751,706. The increase in revenue, net was primarily due to revenue earned from the Distribution Agreement with the Distributor, which was driven by the continued successful commercial acceptance into the post-acute setting of AmnioWrap2.

Cost of Goods Sold

For the six months ended June 30, 2024 and 2023, costs of goods sold were $5,972,600 and $307,253 respectively, an increase of $5,665,347. The increase was primarily attributable to an increase in licensing fees from our accelerated AmnioWrap2 product sales in 2024.

Gross Profit and Gross Profit Margin

For the six months ended June 30, 2024 and 2023, our gross profit was $110,423,609 and $1,337,250, respectively, an increase of $109,086,359. This increase can be attributed mainly to accelerated sales of AmnioWrap2.

For the six months ended June 30, 2024 and 2023, our gross profit margin was 95% and 81%, respectively. The increase in gross profit margin is due to the sale of our lower cost AmnioWrap2 product during 2024 and from manufacturing efficiencies obtained during 2024.

Sales and Marketing Expenses

For the six months ended June 30, 2024, total sales and marketing expenses were $89,549,433, compared to $1,095,373 for the six months ended June 30, 2023, an increase of $88,454,060. The increase is attributable almost entirely to $87,792,126 in BFSF expense due to Venture Medical the distributor of our AmnioWrap2 product. The remaining increase in sales and marketing expenses year over year is

attributable to our increased attendance and sponsorship of trade shows and new marketing materials to support the sales of AmnioWrap2. We expect the BFSF will continue to be largest component of sales and marketing expenses in the near term.

General and Administrative Expenses

For the six months ended June 30, 2024 and 2023, general and administrative expenses were $7,183,774 and $6,169,423, respectively, an increase of $1,014,351. The increase in general and administrative expenses year over year is due to increases in headcount and related stock-based compensation.

Research & Development

Our research and development expenses for the six months ended June 30, 2024 were $155,901, as compared to $130,632 for the six months ended June 30, 2023, an increase of $25,269. The increase in research and development expenses period over period are due to additional expenses incurred for the six months ended June 30, 2024 related to the extension of patent expiration dates on certain products.

Total Operating Expenses

For the six months ended June 30, 2024 and 2023, we incurred total operating expenses of $96,996,886 and $7,513,791, respectively. This represents an increase of $89,483,095. The increase is primarily attributed to increased BFSF related to our Distribution Agreement with Venture Medical, the Distributor of our AmnioWrap2 product and increased stock-based compensation, which was $88,391,449 of the $89,483,095 incremental expense period over period.

Other Expense, net

For the six months ended June 30, 2024 and 2023, we realized other expense, net of $384,679 and $258,573, respectively. This represents an increase of $126,106. This increase is primarily attributed to the amortization of a debt discount associated with a promissory note executed in June 1, 2023 with a warrant with a relative fair value of $305,310 which is being amortized over a two year period.

Net Income (Loss)

Our net income was $9,543,420 for the six months ended June 30, 2024, as compared to a net loss of $6,435,114 for the six months ended June 30, 2023. The improvement was primarily due to revenue earned from the Distribution Agreement with the Distributor, which was driven by the continued successful commercial acceptance into the post-acute setting of AmnioWrap2.

Revenue, net

We earned revenue, net of $16,685,405 for the year ended December 31, 2023, as compared to $6,875,202 for the year ended December 31, 2022, an increase of $9,810,203. The increase in revenue, net was primarily due to the launch of our AmnioWrap2 product in September 2023 through the Distributor.

Cost of Goods Sold

For the years ended December 31, 2023 and 2022, costs of goods sold were $1,260,558 and $881,754, respectively, an increase of $378,804. The increase was primarily attributable to an increase in licensing fees from our accelerated AmnioWrap2 product sales.

Gross Profit

For the years ended December 31, 2023 and 2022, our gross profit was $15,424,847 and $5,993,448, respectively. This represents an increase of $9,431,399. This increase can be attributed mainly to an increase in sales volume from our AmnioWrap2 product combined with a decrease in sales from our higher cost, flowable products.

Sales and Marketing Expenses

For the years ended December 31, 2023 and 2022, our sales and marketing expenses were $11,986,385 and $954,059 respectively. We incurred $9,536,800 in BFSF during the year ended December 31, 2023 from the Distribution Agreement, which was the primary driver of increase in sales and marketing expenses year over year. We incurred $198,168 and $93,288 in advertising expenses for the years ended December 31, 2023 and 2022, respectively.

General and Administrative Expenses

For the years ended December 31, 2023 and 2022, general and administrative expenses were $10,646,421 and $9,252,744, respectively, and consisted mainly of payroll related expenses including stock-based compensation expenses, which were $6,670,116 and $5,377,036 for the years ending December 31, 2023 and 2022, respectively. The remaining increase was primarily attributable to increases in accounting and legal fees as we continued to prepare to become a fully reporting public company and a legal settlement of $720,500 in 2023.

Research & Development Expenses

For the years ended December 31, 2023 and 2022, research and development expenses were $341,996 and $224,775, respectively. The increase in research and development expenses year over year are due to increases in studies to extend the shelf life of our products as well as additional expenditures in evaluating our BioREtain process.

Total Operating Expenses

For the years ended December 31, 2023 and 2022, we incurred total operating expenses of $23,203,816 and $10,674,996, respectively. This represents an increase of $12,528,820. The increase is primarily attributed to increased BFSF related to the Distribution Agreement, which accounted for $9,536,800 of the $12,528,820 incremental expense year over year. The remaining increase is attributed to an increase in headcount and stock-based compensation as well as increased accounting and legal fees as we continue to prepare become a fully reporting public company. We also incurred $720,500 in 2023 associated with a legal settlement. We expect to incur additional headcount cost and BFSF costs as we continue to grow the business.

Other Expense, net

For the years ended December 31, 2023 and 2022, we realized other expense, net of $704,015 and $2,550,248, respectively. This represents a decrease of $1,846,233. This decrease is primarily attributed to a one time debt restructuring charge of $2,083,197 in 2022, partially offset by an increase in interest expense due to new promissory notes executed in 2023.

Net loss

As a result of the above factors, our net loss was $8,482,984 for the year ended December 31, 2023, as compared to a net loss of $7,231,796 for the year ended December 31, 2022.

Liquidity and Capital Resources

Since our inception, we have funded our operations and capital expenditures through cash flows from product sales, third-party debt and proceeds from the sale of our capital stock. We have incurred net losses of $8,482,984, and $7,231,796 for the years ended December 31, 2023 and 2022, respectively, and had an accumulated deficit and working capital deficit of $45,624,117 and $3,021,835 as of December 31, 2023, respectively. We had net income of $6,286,028 and $9,543,420 for the three and six months ended June 30, 2024, respectively, as compared to a net loss of $2,855,026 and $6,435,114 for the three and six months ended June 30, 2023, respectively. We have an accumulated deficit of $36,080,697 and working capital surplus of $12,512,673 as of June 30, 2024.

Our primary uses of cash are working capital requirements, capital expenditure and debt service payments. Additionally, from time to time, we may use capital for acquisitions and other investing and financing activities. Working capital is used principally for our personnel as well as manufacturing costs related to the production of our products. Our working capital requirements vary from period to period

depending on manufacturing volumes, the timing of shipments and the payment cycles of our customers and payers. Our capital expenditures consist primarily of building improvements, manufacturing equipment, and computer hardware and software.

For the next twelve months, we expect to continue to fund our business through revenues generated from the sales of our products. Based on our current level of operations and available cash, we believe our cash flow from operations will provide sufficient liquidity to fund our current obligations, debt service requirements and capital spending over the next twelve months. As a result of our intention to list our common stock on Nasdaq, we will need to hire additional personnel and implement procedures and processes to address public company regulatory requirements and customary practices. We expect to incur additional annual expenses as a public company for, among other things, directors’ and officers’ liability insurance, director fees and additional internal and external accounting and legal and administrative resources, including increased audit and legal fees.

To the extent additional funds are necessary to meet our long-term liquidity needs as we continue to execute on our business strategy, we anticipate that they will be obtained through additional equity or debt financings, other strategic financing transactions or a combination of these potential sources of funds. There can be no assurance that we will be able to obtain additional funds on terms acceptable to us, on a timely basis or at all.

As of December 31, 2023 we had total current assets of $12,599,053 and total current liabilities of $15,620,888. As of June 30, 2024, we had total current assets of $87,982,987 and total current liabilities of $75,470,314.

As of December 31, 2023, we had a cash balance of $239,406, a decrease of $532,730, as compared to $772,136 at December 31, 2022. As of June 30, 2024, we had a cash balance of $6,572,126, an increase of $6,248,412, as compared to $323,714 as of June 30, 2023.

Debt Obligations

GMA Bridge Fund Loans

On July 27, 2018, the Company entered into a $1 million Bridge Loan Agreement and Promissory Note with GMA Bridge Fund, LLC (“GMA”) (the “July 2018 Bridge Note”), with an interest rate of 0.50% per month for the first six months and 0.75% per month through the Maturity Date of July 27, 2019. Amounts outstanding under the July 2018 Bridge Note were not repaid on the maturity date and remain outstanding.

On October 5, 2018, the Company entered into a $2 million Bridge Loan Agreement and Promissory Note (the “October 2018 Bridge Note” and together with the July 2018 Bridge Note, the “Notes”), with an interest rate of 0.50%, per month for the first six months and 0.75% per month through the Maturity Date of October 5, 2019. Amounts outstanding under the October 2018 Bridge Note were not repaid on the maturity date and remain outstanding.

In August 2019, the Company received a default notice from GMA with respect to the Notes based on non-payment. The Company continues to accrue interest on these Notes in accordance with the agreements. On September 23, 2024, GMA submitted a Demand for Arbitration to the American Arbitration Association relating to the repayment of the Notes in the amount of $3,000,000 plus interest.

Convertible Notes

On May 17, 2019, a $400,000 convertible note issued by the Company to an unrelated third party, was amended and restated to include unpaid interest to date of $73,450 and require interest only payments of $4,734 per month at a rate of 12% per annum with a maturity of June 1, 2022. The conversion option within the original promissory note was also eliminated. On March 31, 2022, the note was modified to extend the maturity date of the note to December 31, 2023, and to give the noteholder the right to convert the note into shares of the Company’s common stock at a $0.70 conversion price. On November 10, 2023, the lender elected to convert the unpaid principal of $473,350 into 676,215 shares of the Company's common stock.

On December 23, 2022, the Company issued a convertible promissory note in the amount of $250,000 at a simple interest rate of 5% per annum. Upon maturity on December 23, 2024, all amounts due and owing under the note automatically convert into common stock at a price of $1.00 per share. The noteholder had the right from time to time, commencing on or after the issuance date, to convert any or all amounts due under the note to common shares. In February 2023 the noteholder converted all amounts due under the note, including accrued interest of $2,357, into 252,357 shares of the Company’s common stock.