PART I

Overview

Endonovo Therapeutics, Inc. and Subsidiaries (the “Company” or “ENDV” “we” “us” “our”) is primarily focused in the business of biomedical research and development, particularly in regenerative medicine, which has included the development of its proprietary non-invasive electrocuetical device and intellectual property licensing and commercialization.

Our intellectual property management and commercialization segment is focused primarily on licensing various commercially desirable technologies and patents from companies that need operating capital or that need help commercializing their technology and sublicense such technology in designated territories. This segment acquires exclusive licenses for marketable technology normally without the payment of any upfront license fee to the licensor and thereafter, to sub-license the technology in the designated markets, including Asia, Europe, and Brazil. Our results depend upon our ability to locate available, licensable, and readily marketable technology, to negotiate favorable licenses for such technology, and to sub-license the technology in the designated markets at a sufficient level of volume in an effort to generate maximum revenues. Due to the history of our acquisitions, as set forth below, and management’s assessment of what has been the most promising of our technologies, we have determined to focus ourselves as a developer of biotechnology, particularly in regenerative medicine. We are commercial stage developer of non-invasive medical devices designed to deliver its proprietary Electroceutical™ Therapy for the treatment of inflammatory conditions, cardiovascular diseases and central nervous system disorders.

Corporate History

Our predecessor company, Hanover Asset Management, Inc. was incorporated in November 2008 in California. For the purpose of reincorporating in Delaware, we merged with a newly incorporated successor company, Hanover Portfolio Acquisitions, Inc., in July 2011 under which we continue to operate.

IP Resources International, Inc. began operations on September 1, 2011 and was formally incorporated on October 17, 2011.

Reverse Acquisition

On March 14, 2012, we entered into a Share Exchange Agreement (“Agreement”) with IPR and certain of its shareholders. Under the Agreement, each participating IPR shareholder exchanged all of their issued and outstanding IPR common shares totaling 33,234,294, free and clear of all liens, and $155,000 for Company common shares equal to 1.2342 times the number of IPR shares being transferred to the Company for a total of 410,177 of our shares. The $155,000 was not paid at closing. The Company recorded the $155,000 as acquisition payable. IPR agreed to make payments of up to 25% of the proceeds from any private placement or gross profits earned by IPR until the obligation is satisfied. The percentage of the proceeds to be paid is at the sole discretion of IPR’s Chief Executive Officer and the ex-Chief Executive Officer of the Company based on the liquidity of the Company.

As a result of the Agreement, the former shareholders of IPR, immediately post acquisition owned approximately 89% of the Company and its officers and directors constituted the majority of the officers and directors of the Company. Since the shareholders, officers and directors of IPR have control of the Company, the acquisitions constitutes a reverse acquisition, so IPR was the accounting acquirer and we were the accounting acquiree. For accounting purposes, IPR became the parent and we became a wholly owned subsidiary. For legal purposes, we are the legal parent and IPR is the legal subsidiary.

Acquisition of Aviva Companies Corporation

On April 2, 2013, the Company entered into an Acquisition Agreement (the “Acquisition Agreement”) with (i) The Aviva Companies Corporation (“Aviva”) and (ii) all of the shareholders of Aviva (the “Shareholders”) pursuant to which the Company acquired all of the outstanding shares of Aviva in exchange for the issuance of 60,000 shares of our common stock, par value $0.0001 per share to the Shareholders (the “Share Exchange”). As a result of the Share Exchange, Aviva became a wholly-owned subsidiary of the Company.

Other than in respect to the transaction, there is no material relationship among Aviva’s stockholders and any of the Company’s affiliates, directors or officers. We are not currently actively pursuing the development of the Aviva Companies Corporation.

Acquisition of WeHealAnimals, Inc.

On November 16, 2013, the Company entered into an Acquisition Agreement (the “Acquisition Agreement”) with (i) WeHealAnimals ,Inc. (“WHA”) and (ii) the sole shareholder of WHA (the “Shareholder”) pursuant to which the Company acquired all of the outstanding shares of WHA in exchange for the issuance of 3,000 shares of our common stock, par value $0.0001 per share and $96,000 to the Shareholder (the “Share Exchange”). As a result of the Share Exchange, WHA became a wholly-owned subsidiary of the Company and all of the equity of WHA including its and its sole shareholder’s intellectual property became the property of the Company. This obligation was fully paid on December 15, 2015 through the issuance of 350,000 shares of stock to the CEO of WHA. WHA is a Nevada corporation with intellectual property in the fields of bio-technology including its biologics and time-varying electromagnetic frequencies with potential applications on people and animals that management believes can be developed to the benefit of the Company and its shareholders. WHA’s sole shareholder was formerly Chairman and Chief Scientist of Regenetech, Inc. Regenetech was acquired by a company that wanted its technology, biomolecules grown in microgravity, for use in cosmetics. WHA’s sole shareholder left Regenetech with exclusive rights to this proprietary non-invasive electrocuetical technology and stem cell technologies, including the patents and patent applications relating thereto.

Other than in respect to the transaction, there is no material relationship between WHA’s sole stockholder and any of the Company’s affiliates, directors or officers.

Present Development Plans

Establish SofPulse™ as standard care for post-surgical healing in cosmetic surgery

We will seek to commercialize our Electroceutical™ Therapy for the treatment of pain and post-surgical edema with a specific concentration on cosmetic surgeries, including breast augmentation, reduction and reconstruction surgery, rhinoplasty, and liposuction procedures. An American Society of Plastic Surgeons report found Americans spent more than $16 billion on cosmetic plastic surgeries and minimally invasive procedures in 2016, the most the U.S. has ever spent on such operations. In 2016, 290,467 breast augmentation surgeries were performed, 223,018 rhinoplasty procedures, 127,633 tummy tucks, 235,237 liposuction procedures, and 18,489 buttock augmentations were performed across the U.S., respectively.

We will seek to target this market by hiring a small 10 to 15 person sales team specifically targeting cosmetic surgeons. We currently have a small group of cosmetic surgeons who prescribe our Electroceutical™ Therapy to their patients and include the cost of our Electroceutical™ Therapy in the total cost of the procedure. We will also pursue licensing and/or distribution agreements for cosmetic surgery indications.

Our Electroceutical™ Therapy was previously licensed to Allergan by Ivivi Technologies (predecessor firm and original owner of SofPulse™) for the cosmetic surgery market. This licensing agreement was terminated when Ivivi Technologies failed to secure FDA-Clearance for the palliative treatment of pain and post-surgical edema. We believe that a similar licensing agreement or a marketing/distribution agreement can be secured to target the cosmetic surgery market.

Establish dedicated sales team to target skilled nursing facilities and the elderly care market

We will seek to market and sell our Electroceutical Therapy to skilled nursing facilities (SNFs), which include both long-term residential care and short-term post-acute or rehabilitative care.

While the number of Americans living in SNFs for extended periods has fallen steadily over the past decade as an increasing proportion of older individuals remain in their homes or in assisted living facilities, the number receiving short-term nursing care has risen dramatically. In 2014, 1.7 million fee- for-service (FFS) Medicare beneficiaries were cared for in 15,000 SNFs, costing Medicare USD $28.6 billion. This represents 2.4 million SNF stays: 20 percent of all hospitalized FFS Medicare beneficiaries are discharged to a SNF. The majority of these facilities are the same institutions as those providing residential long-term care: 95 percent of SNFs provide both kinds of care ⁱ .

SNF residents, whether short- or long-term, tend to be old, female, and have multiple impairments in their activities of daily living (ADLs). Of those in SNFs in 2014, 16.6 percent were between the ages of 65 and 74, 26.6 percent were between 75 and 84, 33.7 percent were between 85 and 94, and 7.8 percent were 95 years of age or older ⁱⁱ . In the same population, 6.1 percent had impairments in three ADLs, 41.2 percent had impairments in four ADLs, and 22.4 percent had impairments in five ADLs. Cognitive impairment is also widespread in this population, with 36.9 percent exhibiting severe impairment, 24.9 percent having moderate impairment, and 38.2 percent with mild or no impairment.

SNF care represents a substantial segment of health care costs for older individuals: in the United States in 2010, $143 billion was spent on SNF care, of which 14 percent was paid by Medicare, 63 percent by Medicaid, and 22 percent privately ⁱⁱⁱ . The costs of care are covered differently, depending on whether the patient is receiving long- or short-term care.

In addition to the use of our Electroceutical™ Therapy for the palliative treatment of pain and post-surgical edema, our Electroceutical™ Therapy received CMS National Coverage for the treatment of chronic wounds in 2004. We believe that this reimbursement will allow SNFs to purchase our SofPulse™ medical devices for treating elderly patients suffering from chronic wounds and pressure ulcers, which affects between 8 to 28 percent of all nursing home patients. Pressure ulcers are both common and very costly, and on average, per Medicare’s self-reporting of claims payments, a single hospitalization related to an acute pressure sore treatment need of a patient often resulted in prolonged stays due to complications and the slow healing process of the wound itself.

On average, these stays for stage two or higher pressure ulcers cost insurers no less than $16,000 per patient, who frequently requires eight (8) to nine (9) additional days in an extremely costly hospital care setting due to the precarious nature of bedsore injuries in the elderly. On average, these stays for stage two or higher pressure ulcers cost insurers no less than $16,000 per patient, who frequently requires eight (8) to nine (9) additional days in an extremely costly hospital care setting due to the precarious nature of bedsore injuries in the elderly.

We believe our Electroceutical Therapy presents both cost savings opportunities for SNFs and improve patient outcomes. We will seek to target these approximately 15,000 SNFs using the same small sales and marketing team outlined above.

Pursue licensing and/or distribution agreements to enter European market

Our Electroceutical™ Therapy (SofPulse™) received CE Mark certification for commercial distribution in the member countries of the European Union for use in the promotion of wound healing, reduction of pain and post operative edema. We will seek commercial partners and or marketing/distribution agreements to penetrate the European market. We anticipate a significant amount of our efforts will concentrate on wound healing due to the aging population in the European Union and a lack of effective treatment options for patients with pressure ulcers/chronic wounds.

ⁱ Medicare Payment Advisory Committee. Report to the Congress: Medicare payment policy. Washington, DC 2016.

http://medpac.gov/documents/reports/march-2016-report-to-the-congress-medicare-payment-

ⁱⁱ Centers for Medicare and Medicaid Services. Nursing Home Data Compendium, 2015. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/CertificationandComplianc/Downloads/nursinghomedatacompendium_508-2015.pdf

ⁱⁱⁱ Henry J Kaiser Family Foundation. Overview of nursing facility capacity, financing, and ownership in the United States. June 2013.

http://kff.org/medicaid/fact-sheet/overview-of-nursing-facility-capacity-financing-and-ownership-in-the-united-states-in-2011/

Design neurology-specific devices to deliver our Electroceutical™ Therapy

We are currently in the process of designing a neurology-specific medical device to deliver our Electroceutical™ Therapy for the treatment of central nervous system disorders. We believe the design and functionality of our CNS- specific devices is a critical component for market penetration and share, as well as patient compliance.

Furthermore, the design of a CNS-specific medical device will allow our Electroceutical Therapy to be more precisely delivered to the brain. Additionally, in most cases, our Electroceutical™ Therapy will be used at home and self-administered by patients. Therefore, the design, fit, and functionality of our CNS-specific devices will be critical to achieve patient compliance, market penetration and adoptions, and ultimately clinically meaningful outcomes.

Design cardiovascular-specific devices to deliver our Electroceutical™ Therapy

Prior to pursuing a larger clinical trial to assess the efficacy of our Electroceutical™ Therapy for the treatment of ischemic cardiomyopathy, we will seek to design a cardiovascular-specific medical device to target the heart. The pilot clinical trial conducted on “no option” ischemic cardiomyopathy patients used an older version of our medical devices, which were secured on patients using a garment. We believe the fit, design and functionality of our medical devices used to deliver our Electroceutical Therapy in cardiovascular disease patients will be a critical component to patient compliance, market penetration and adoption, as well as the achievement of clinically meaningful outcomes.

Pursue a Humanitarian Device Exemption for treating encephalopathy in Lyme disease patients

We are seeking to enter the CNS market via a Humanitarian Device Exemption (HDE), which is regulatory pathway for medical devices addressing rare diseases that occur in no more than 8,000 individual per year in the United States. The HDE pathway is the medical device equivalent of orphan drugs and is similar in both form and content to an FDA Pre-Market Approval (PMA). However, rather than being required to demonstrate safety and efficacy, the HDE pathway allows for medical devices to receive FDA Approval if they can demonstrate that their probable benefit outweighs their probable risk.

We will seek to enter the CNS market via a HDE for the treatment of encephalopathy in Lyme disease patients. Our FDA-Cleared Electroceutical Therapy is currently prescribed by a group of physicians to reduce neuroinflammation. We will seek to gather data from approximately 10 to 15 patients to support a Humanitarian Device Exemption from the FDA to reduce neuroinflammation in Lyme disease patients.

In general, the HDE pathway contains restrictions on profit for medical device manufactures. However, the Food and Drug Administration Amendments Act of 2007 (FDAAA) contained incentives to facilitate development of medical devices for pediatric populations (defined as patients who are younger than 22 years of age). Under section 520(m)(6)(A)(i) of the FD&C Act, an HUD is only eligible to be sold for profit after receiving an HDE approval if the device is intended for the treatment or diagnosis of a disease or condition that either:

The number of HDE devices that may be sold for profit is limited to a quantity known as the Annual Distribution Number (ADN). If the FDA determines that an HDE holder is eligible to sell the device for profit, FDA will determine the ADN and notify the HDE holder. The ADN is calculated by taking the number of devices reasonably necessary to treat or diagnose an individual per year and multiplying it by 8000. For example, if the typical course of treatment using an HDE device, in accordance with its intended use, requires the use of two devices per patient per year, then the ADN for that HDE device would be 16,000 (i.e., 2 x 8000). If the number of devices distributed in a year exceeds the ADN, the sponsor can continue to sell the device but cannot earn a profit for the remainder of the year.

We believe encephalopathy in Lyme disease patients may allow us to sell our medical devices for profit.

Our initial step to pursue this pathway is to file an application to the FDA to designate our medical device as a Humanitarian Use Device (HUD), which is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year. In order to obtain HUD designation, the applicant must provide documentation, with appended authoritative references, to demonstrate that the device meets this definition. In addition to the documentation describing the disease or condition, the applicant must also provide the proposed indications for use of the device, and the reasons why such a device is needed for the patient population. One aspect that has become increasingly difficult is if the HUD is proposed for an indication that represents a subset of a common disease or condition. In these situations, the applicant must demonstrate that the subset is an “orphan subset.” An “orphan subset” is a regulatory phrase used to describe the subset of individuals with a non-rare disease or condition on who use of a device is appropriate, where use of the device on the remaining individuals with that disease or condition would be inappropriate given some intrinsic feature of the device (e.g., adverse event profile or mode of action). An “orphan subset” is not a readily identifiable subset or a group of patients who meet or do not meet the inclusion and exclusion criteria for a clinical study. Likewise, they are not patients with an unmet medical need. If the HUD application is designated, the applicant can then submit the HDE marketing application to the Center for Devices and Radiological Health (CDRH) or Center for Biologics Evaluation and Research (CBER) for marketing review.

The figure below is an estimated regulatory timeline to obtain a Humanitarian Device Exemption for our Electroceutical™ Therapy for the treatment of encephalopathy in Lyme disease patients.

Pursue a “label expansion” strategy in CNS disorders

If we are able to secure a Humanitarian Device Exemption for our Electroceutical™ Therapy from the FDA for the treatment of encephalopathy in Lyme disease patients, we will then pursue a “label expansion” strategy. This would entail entering the CNS market via the HDE pathway for the treatment of encephalopathy in Lyme disease patients and then applying to expand the label for our Electroceutical Therapy for other CNS disorders we are pursuing, including acute concussion, traumatic brain injury, post-concussion syndrome, multiple sclerosis and stoke. This strategy will require that we conduct several clinical trials simultaneously in order to fully benefit from pursuing a HDE pathway and label expansion strategy; such benefits include a potentially shorter and less costly regulatory process for our other CNS indications.

Leverage our first-to-market position to rapidly drive market penetration

There are currently no effective treatments for most CNS disorders and many pharmaceutical companies, such as Pfizer are shifting their resources to other indications outside of CNS disorders. Furthermore, several of our competitors in neurological devices, including implantable vagus nerve stimulators, trigeminal nerve stimulators, Transcutaneous Magnetic Stimulation (TMS), Transcutaneous Direct Current Stimulators (tDCS), suffer from a lack of understanding of their mechanism of action, a lack of industrial design and engineering to increase their market penetration and adoption. These factors may allow us to reach market faster and capture a significant market share. Furthermore, we believe elegant design of CNS-specific devices with market leading fit and functionality may allow us to increase market penetration and adoption in CNS disorders, which represent a substantially unmet clinical need.

Expand our Electroceutical™ Therapy into peripheral artery disease (PAD), non-alcoholic fatty liver disease (NAFLD) and chronic kidney disease (CKD)

We are currently conducting several pre- clinical studies to assess the effectiveness of our Electroceutical Therapy in animal models of critical limb ischemia (CLI), non-alcoholic steatohepatitis (NASH) and renal inflammation.

We recently completed a mouse model of CLI, which found that animals treated three times per day with the our Pulsed Electromagnetic Fields (PEMF) device had significantly higher blood flow (ratio of blood flow of the ischemic limb to blood flow of non-ischemic limb) at day 7 and 14 (57% and 71%, versus 36% and 52%) versus the controls. Furthermore, animals treated with PEMF three times per day had significantly improved foot movement scores and less tissue damage in the ischemic hind limb versus the controls. Critical Limb Ischemia (CLI) is an advanced stage of Peripheral Artery Disease (PAD), a common vascular disease that affects approximately 200 million people worldwide, where fatty deposits block arteries in the legs, leading to pain, non-healing ulcers, and gangrene. Worldwide, approximately 22-30 million people suffer from CLI, according to The Sage Group. Patients with CLI have a high risk of amputation and death, and patients unsuitable for revascularization are left with no adequate treatment options.

Furthermore, we are preparing to evaluate the effectiveness of our Electroceutical™ Therapy in reducing liver inflammation in a mouse model of non-alcoholic steatohepatitis (NASH). The American Liver Foundation estimates that up to 30% of the U.S. population is affected by non-alcoholic fatty liver diseases, including NASH and other obesity related liver ailments. NASH is liver inflammation and cellular damage caused by a buildup of fat in the liver. NASH occurs in people who drink little or no alcohol, especially people who are middle-aged and overweight or obese. Approximately 20% of NASH cases result in scarring of the liver and cirrhosis if untreated, with the most acute cases often requiring liver transplantation. There are no approved therapies for the treatment of NASH and there are few pharmaceutical therapies nearing approval over the next several years.

We are also preparing to evaluate the effectiveness of our Electroceutical™ Therapy in the treatment of renal inflammation in a unilateral ureter obstruction (UUO) animal model. More than 31 million people in the United States are currently living with chronic kidney disease (CKD), according to the American Kidney Fund. Diabetes and high blood pressure are the most common causes of kidney disease. Chronic kidney disease means lasting damage to the kidneys that can get worse over time and in cases where the damage is severe, it can lead to kidney failure, also known as end-stage renal disease. If the kidneys fail the only option for patients is a kidney transplant or dialysis. According to the National Institute of Diabetes and Digestive and Kidney Disease (NIDDK), the five-year survival rate for dialysis patients is only 35.8%, in comparison to a five-year survival rate of 85.5% for transplant patients. However, there are currently 100,791 people waiting for a kidney transplant, according to the National Kidney Foundation. This severe donor kidney shortage means that the median wait time for a patient’s first kidney transplant is 3.6 years. A significant rise in the pool of patients suffering from CKD, particularly the rising number of elderly people prone to a variety of diseases, such as diabetes, cardiovascular disorders and neurological conditions that affect the kidneys severely will grow the demand for CKD treatments.

The market for chronic kidney disease (CKD) drugs is estimated to reach $15.8 billion by 2024, according to Transparency Market Research. Several kidney diseases have a strong inflammatory component and our aim is to demonstrate the anti-inflammatory and anti-fibrotic properties of our Electroceutical™ Therapy. Reversing inflammation in the kidneys that can cause injury, fibrosis and ultimately end-stage renal disease may provide a significant opportunity for our Electroceutical Therapy to achieve high market penetration and adoption as well as produce significantly meaningful clinical outcomes.

Pursue potential licensees or strategic partnerships for chronic kidney disease (CKD)

We believe a significant opportunity for our Electroceutical™ Therapy will be in the adjunctive treatment of chronic kidney disease. Chronic kidney disease is a type of kidney disease in which there is a gradual loss of kidney function over a period of months or years.

Causes of CKD include diabetes, high blood pressure, glomerulonephritis, and polycystic kidney disease. The diagnosis of CKD is generally by blood tests to measure the glomerular filtration rate and urine tests to measure albumin. Further tests, such as an ultrasound or kidney biopsy may be done to determine the underlying cause.

Chronic kidney disease affected about 323 million people globally in 2015 ^iv . In 2015 it resulted in 1.2 million deaths, up from 409,000 in 1990. The causes that contribute to the greatest number of deaths are high blood pressure at 550,000, followed by diabetes at 418,000, and glomerulonephritis at 238,000.

All individuals with a glomerular filtration rate (GFR) <60 ml/min/1.73 m2 for 3 months are classified as having chronic kidney disease, irrespective of the presence or absence of kidney damage. The rationale for including these individuals is that reduction in kidney function to this level or lower represents loss of half or more of the adult level of normal kidney function, which may be associated with a number of complications such as the development of cardiovascular disease ^v .

Protein in the urine is regarded as an independent marker for worsening of kidney function and cardiovascular disease. Hence, British guidelines append the letter “P” to the stage of chronic kidney disease if protein loss is significant ^vi .

Inflammation as an essential part of CKD has been recognized since the 1990’s, when it was liked to cardiovascular disease, protein-energy wasting, and mortality ^vii,viii . Over the last 15 years there has been a growing interest in inflammation in CKD and end-stage renal disease (ESRD), which led to the change in the perception of inflammation from a novel to a well-established risk factor of morbidity and mortality in CKD.

The inverse correlation between glomerular filtration rate (GFR) and inflammation has now been proven. In the Chronic Renal Insufficiency Cohort (CRIC) study, biomarkers of inflammation (IL-1β, IL- 1 receptor antagonist, IL-6, TNF-α, CRP, and fibrinogen) were inversely associated with the measures of kidney function and positively with albuminuria ^ix . Inflammation is present not only in adult, but also in pediatric patients with CKD/ESRD ^x . The figure below outlines the causes and consequences of inflammation in chronic kidney disease:

A variety of interventions that have been proposed to target inflammation in CKD can be divided into three broad categories: lifestyle modifications, pharmacological interventions, and optimization of dialysis ^xi .

For ESRD patients, two main approaches to decrease inflammatory load related to the dialysis procedure were proposed: elimination of factors triggering inflammation and direct removal of inflammatory mediators ^xii .

^iv GBD 2015 Disease and Injury Incidence and Prevalence, Collaborators. (8 October 2016). “Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015”. Lancet. 388 (10053): 1545–1602.

^v National Kidney Foundation (2002). “K/DOQI clinical practice guidelines for chronic kidney disease”

^vi National Institute for Health and Clinical Excellence. Clinical guideline 73: Chronic kidney disease. London, 2008.

^vii Stenvinkel P, Heimburger O, Paultre F, Diczfalusy U, Wang T, Berglund L, Jogestrand T: Strong association between malnutrition, inflammation, and atherosclerosis in chronic renal failure. Kidney Int 1999;55:1899- 1911.

^viii Zimmermann J, Herrlinger S, Pruy A, Metzger T, Wanner C: Inflammation enhances cardiovascular risk and mortality in hemodialysis patients. Kidney Int 1999;55:648-658.

^ix Gupta J, Mitra N, Kanetsky PA, Devaney J, Wing MR, Reilly M, Shah VO, Balakrishnan VS, Guzman NJ, Girndt M, Periera BG, Feldman HI, Kusek JW, Joffe MM, Raj DS: Association between albuminuria, kidney function, and inflammatory biomarker profile in CKD in CRIC. Clin J Am Soc Nephrol 2012;7:1938-1946.

^x Goldstein SL, Leung JC, Silverstein DM: Pro- and anti-inflammatory cytokines in chronic pediatric dialysis patients: effect of aspirin. Clin J Am Soc Nephrol 2006;1:979-986.

^xi Carrero JJ, Yilmaz MI, Lindholm B, Stenvinkel P: Cytokine dysregulation in chronic kidney disease: how can we treat it? Blood Purif 2008;26:291-299.

^xii Santoro A, Mancini E: Is hemodiafiltration the technical solution to chronic inflammation affecting hemodialysis patients? Kidney Int 2014;86:235-237.

We are developing our Electroceutical™ Therapy to target inflammation in CKD and ESRD patients. We believe seeking commercial partnerships with several of the largest providers of dialysis may allow our Electroceutical™ Therapy to achieve high market penetration and adoption. Figure 1 below outlines the 10 largest U.S. dialysis providers in 2017.

We anticipate our Electroceutical™ Therapy will be used as an adjunctive therapy in the treatment of inflammation in CKD and ESRD and may not represent a replacement for hemodialysis in patients. However, we believe our Electroceutical™ Therapy may be used early on as an adjunctive treatment in CKD to potentially prevent or delay the progression of CKD to end-stage renal disease by alleviating inflammation and improving glomerular filtration rate (GFR).

Protect and expand our intellectual property

We will continue to protect and expand our portfolio of intellectual property in the non-invasive electrotherapeutic device sector. Our portfolio of intellectual property includes 27 issued patents with foreign patent protection.

Our issued patents include both apparatus and method claims in the treatment of tissues and organs using electromagnetic fields. Our patents for treating certain CNS disorders, including neurological injuries caused by stoke, neurodegenerative conditions and head, cerebral and neural injury in animals and humans were granted by the United States Patent and Trademark Office in 2016. Furthermore, we currently have several pending patent applications for the treatment of certain CNS disorders.

We also have a U.S. Patent (US 8,415,123) covering an electromagnetic apparatus and method for angiogenesis modulation of living tissues and cells that covers the use of our technology and Electroceutical™ Therapy for promoting angiogenesis in cardiovascular disease, cerebral diseases, cerebrovascular diseases, peripheral vascular disease and chronic soft tissue wounds.

We will seek to expand our portfolio of intellectual property to include newly developed apparatuses and methods for treating liver and kidney diseases.

Intellectual Property:

Rio Grande Neurosciences, Inc. Assets

On December 22, 2017, we exercised an option (the “Option”) to acquire intellectual property and other assets (the “RGN Assets”) from Rio Grande Neurosciences, Inc. (RGN). The Option’s price was $4,500,000 of which we paid $3,000,000 in cash and delivered a $1,500,000 secured promissory note due November 30, 2018 and security agreement. We were granted the Option pursuant to a Settlement Agreement and Mutual Release (the “Settlement”) by and among us, RGN, and RGN’s principal shareholder which ended litigation brought by us related to our previous agreement with RGN. The terms of the settlement included a payment of $150,000 to us by RGN (which has been received) and the grant of the Option. The $3,000,000 Option payment was available due to the sale of $700,000 of a new class of preferred stock, a $1,800,000 secured convertible note from Eagle Equities, LLC, and the application of available company funds. The RGN Assets relate to RGN’s Pulsed Electromagnetic Field Therapy (PEMF) portfolio of intellectual property, including 27 issued patents with foreign patent protection covering the therapeutic use of PEMF as well as the treatment of various central nervous system disorders. We intend to initiate and fund both currently planned and all future clinical trials to evaluate the use of PEMF in the treatment of central nervous system disorders, including traumatic brain injury, post-concussion syndrome, stroke and multiple sclerosis. However, no assurance can be given that we will be successful in these endeavors or that the results of any tests will indicate further development of the RGN Assets.

The PEMF assets acquired under the Option also include a portable, disposable PEMF device with a CE Mark and an FDA 510(k) clearance for the treatment of soft tissue injuries and post-surgical pain and edema in addition to medical reimbursement for the treatment of chronic wounds. Endonovo Therapeutics will begin the commercialization of the PEMF assets through licensing and joint venture agreements and the creation of various sales channels and distribution agreements.

We will continue to seek to strengthen our portfolio of intellectual property by filing additional patents around uses of our core technologies. We will continue to develop applications of our technologies that we may license out to our competitors in the drug/pharmaceutical and life sciences industry. To date, we have filed seven patent applications in the U.S. through the U.S. Patent and Trademark Office (USPTO) and four international patent applications in the E.U., China, South Korea and Japan covering our technology, the production of biomolecules, the creation of an allogeneic mesenchymal stem cell product a treatment for chemical and radiation injuries, production of stem cell secretome and a method of treating tissues and organs using our TVEMF technology. To date, we have been granted one U.S. Patent (U.S. Patent No. 9,410,143) issued on August 9, 2016 covering the production of human biomolecules using our technology.

Our business strategy is aimed at building value by positioning each of our technologies and therapies to treat specific diseases that lack effective treatment or whose current standard of treatment involves invasive procedures and/or potentially harmful side effects. We anticipate updating and refining the business strategy as new medical and/or clinical advancements are made as a result of extensive research and development.

Industry Overview

Regenerative Medicine

The regenerative medicine/tissue engineering industry is a rapidly growing interdisciplinary field involving the life, physical and engineering sciences and seeking to develop clinical therapies for the repair, maintenance, replacement and/or enhancement of biological function. Regenerative medicine has a wide area of applications, such as musculoskeletal diseases, cardiovascular, neurology, orthopedic, and other disorders. The regenerative medicine industry is now regarded as having begun with the advent of cell culture in the very early part of the twentieth century, and continues to advance as technological advancements have been made.

The regenerative medicine industry is driven by several technological advancements in stem cell therapy and tissue engineering therapy. The regenerative medicine market is expected to grow to a value of US$6.5 billion by 2019 from a value of US$2.6 billion in 2012, according to Transparency Market Research.

Neurological Devices

The global neurology devices market size was valued at USD $6.2 billion in 2014, according to Grand View Research. The growing advancement in the field of imaging technologies and the consequent development of neurological endoscopy devices are likely to drive growth over the period from 2012 to 2022. Globally, the neurology devices market is expected to reach a value of USD $10.8 billion by 2022.

Furthermore, a rise in the incidence of cerebral stroke and other severe disorders, such as Alzheimer's disease and Parkinson's disease is expected to fuel demand for neurological devices. According to the National Institute of Neurological Disorders and Stroke (NINDS), approximately 50 million Americans are affected due to these disorders, which present high economic and disease cost burden for medical expenses and a loss of productivity.

Globally, there are approximately 15 million strokes per year according to the World Health Organization (WHO) and of these, 5 million die and another 5 million are permanently disabled.

In 2014, neurostimulation devices, which include our proprietary medical devices, accounted for 50% of the revenue generated in the market. The growing number of chronic CNS disorders, the global aging population and the development of minimally invasive neurological and faster acting stimulation devices that attract higher market usage and penetration will drive growth.

Bioelectronic Medicine

The bioelectronic medicine industry is a rapidly expanding segment that seeks to harness electrical signals in nerves and cells to alter the course of diseases and conditions. These technologies seek to stimulate what is known as the inflammatory reflex, a phenomenon where the nervous system sends signals to tissues and organs to suppress inflammation. It is widely believed that these signals send by the nervous system are electrical impulses.

Currently a significant portion of the bioelectronic medicine market is concentrated on the development of implantable neurostimulators, such as vagus nerve stimulators. The bioelectronic medicine market is being driven by innovations and management expects it to grow significantly as new therapies are brought to market. The global electroceuticals/bioelectric medicine market is expected to reach USD 25.20 billion by 2021 from USD 17.20 billion in 2016, growing at a CAGR of 7.9% from 2016 to 2021, according to Markets and Markets.

Cell Therapy Market

The global stem cell market, which is a segment of the regenerative medicine market is forecast to grow at a compounded annual growth rate (CAGR) of 39.5% from 2015-2020, to reach a value of US$330 million by 2020, according to Markets and Markets. North America is expected to hold the largest share of this market due to extensive government funding and increased fast-track approvals for stem cell therapeutics by the FDA.

Competition

The biotech and regenerative therapy industries are capital intensive and highly competitive and many of our competitors have far greater assets than we have presently and will have even if all of the funding possibly available to us is realized. We will seek to compete by establishing the uniqueness, efficacy and other advantages of our technologies and the therapies based upon it.

The Company anticipates significant competition to maximize the value of regenerative therapies from competitors within the biotechnology sector. These competitors will look to bring to market medical technologies and therapies of their own to compete with the Company.

The Company has progressed on the belief that the major competitors in the biotechnology field are currently developing products that will be ineffective in extending and enhancing the human life by regenerating tissues and organs. The Company's platform using its PEMF technology present potentially safer, more effective and lower costing treatments for various autoimmune, vascular, inflammatory and degenerative diseases.

Whereas, the Company's major competitors seek to bring to market technologies and therapies that are inferior, costlier and do not suit the dire need to treat various vascular, inflammatory, autoimmune and degenerative diseases. The Company has acquired medical technology currently being advanced and reconfigured to treat vascular and inflammatory diseases and continues to pursue and develop other non-invasive, regenerative medicine technologies that can be brought to market in a relatively short amount of time compared to pharmaceutical-based treatments being developed by its competitors. These technologies have the potential to prolong and improve the life of humans around the world.

We believe that our disruptive platforms, our industry relationships and experienced team will allow us to capture significant market share and position the Company to become the industry leader in regenerative medicine.

Employees

We do not have any employees. However, we have retained approximately 15 individuals as independent contractors that are involved in business development and administrative functions.