UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 18, 2023

Femasys Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-40492
11-3713499
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification No.)

3950 Johns Creek Court, Suite 100
Suwanee, Georgia
  
30024
(Address of principal executive offices)
  
(Zip Code)

(770) 500-3910
(Registrant’s telephone number, including area code)

n/a
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Exchange Act:
Title of each class
  
Trading
Symbol(s)
  
Name of each
exchange
on which registered
Common Stock, par value $0.001 per share
   FEMY
  
The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

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. ☒

Item 8.01
Other Events

On April 18, 2023, Femasys Inc. (the “Company”) announced that FemaSeed, its localized directional insemination for infertility solution, received product approval in Canada. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

Item 9.01
Financial Statements and Exhibits.

(d)
Exhibits.
 
Exhibit
No.
Description
   
Press Release of Femasys Inc. dated April 18, 2023.

SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
Femasys Inc.
 
By:
/s/ Kathy Lee-Sepsick
 
Names: Kathy Lee-Sepsick
 
Title: Chief Executive Officer
Date: April 18, 2023
  

 
Exhibit 99.1
 
Femasys’ FemaSeed Localized Directional Insemination for Infertility Receives Product Approval in Canada
 
- FemaSeed® is the first-ever, first-line approach designed to deliver sperm directly where contraception occurs
 
ATLANTA, April 18, 2023 -- Femasys Inc. (NASDAQ: FEMY), a biomedical company aiming to meet women’s needs by developing a suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health, today announced the Health Canada, the Public Health Agency of Canada, has granted product approval of FemaSeed®, the first-ever infertility solution designed to deliver sperm directly to where contraception occurs. FemaSeed is Femasys’ localized artificial insemination option that is designed to be less invasive and more affordable than assisted reproduction, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
 
“We are thrilled to gain approval of FemaSeed in Canada, now being able to offer a safe, novel and affordable option for treating infertility,” stated Kathy Lee-Sepsick, Femasys’ founder, president, chief executive officer. “Our advanced approach delivers sperm directly to the area where conception occurs in the fallopian tube. Prior to FemaSeed, Femasys’ first-of-its-kind in-office ultrasound diagnostic product FemVue®, which is also approved in Canada, can be used to  assess that the fallopian tube is patent. Both of these proprietary solutions will offer women and couples in Canada cutting-edge options that are affordable and safe.”
 
Assisted forms of reproductive treatment such as in-vitro fertilization (“IVF”) or intracytoplasmic sperm injection (“ICSI”) are both effective first-line treatments for infertility but are associated with significant costs and risks.
 
Ms. Lee-Sepsick, continued, “In terms of FemaSeed’s availability in the rest of North America, we are progressing after receiving IDE approval from the United States Food and Drug Administration (FDA) in the fourth quarter of last year. We are on track to complete enrollment of our de novo clinical trial of FemaSeed this year, with a potential commercial launch of FemaSeed in the U.S. projected in 2024, if cleared by the FDA.”
 
About FemaSeed

FemaSeed features intrauterine directional delivery that deposits sperm locally and directly to the fallopian tube where conception occurs. As the first and only approach presenting significant advantages over existing artificial insemination solutions, it is intended to become a first-line treatment for infertility.  A component of treatment with FemaSeed includes infertility evaluation using companion diagnostic, FemVue® to provide the first, in-office ultrasound diagnosis of the fallopian tubes.

About FemVue
 
FemVue is the first FDA-cleared product that creates natural saline and air contrast and enables safe, reliable, and real time evaluation of the fallopian tubes with ultrasound. When performed with a uterine cavity assessment, a more comprehensive exam can be achieved from the comfort of the gynecologist’s office.
 
About Femasys
 
Femasys Inc. is a biomedical company aiming to meet women’s needs worldwide by developing a suite of products and product candidates that include minimally invasive, in-office technologies for reproductive health. Its two lead product candidates are FemBloc® permanent birth control and FemaSeed® localized directional insemination for infertility. The Company’s products currently marketed in the United States, include FemVue® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath™, an intrauterine catheter for selective evaluation of the fallopian tubes, and FemCerv®, an endocervical tissue sampler that is the first product of the technology platform for tissue sampling.
 
Forward-Looking Statements
 
This press release contains forward-looking statements that are subject to substantial risks and uncertainties. Forward-looking statements can be identified by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “pending,” “intend,” “believe,” “potential,” “hope,” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on our current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: our ability to develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our product candidates; our business model and strategic plans for our products, technologies and business, including our implementation thereof; and those other risks and uncertainties described in the section titled “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 and other reports as filed with the SEC. Forward-looking statements contained in this press release are made as of this date, and Femasys undertakes no duty to update such information except as required under applicable law.
 
Contacts:
 
Investors

Chuck Padala
LifeSci Advisors, LLC
+1-917-741-7792
chuck@lifesciadvisors.com

Femasys Inc.

Investor Contact:
IR@femasys.com

Media Contact:
Media@femasys.com