0001140361-24-011613.txt : 20240306 0001140361-24-011613.hdr.sgml : 20240306 20240306090927 ACCESSION NUMBER: 0001140361-24-011613 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 15 CONFORMED PERIOD OF REPORT: 20240306 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20240306 DATE AS OF CHANGE: 20240306 FILER: COMPANY DATA: COMPANY CONFORMED NAME: FEMASYS INC CENTRAL INDEX KEY: 0001339005 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] ORGANIZATION NAME: 08 Industrial Applications and Services IRS NUMBER: 113713499 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-40492 FILM NUMBER: 24724510 BUSINESS ADDRESS: STREET 1: 3950 JOHNS CREEK COURT STREET 2: SUITE 100 CITY: SUWANEE STATE: GA ZIP: 30024 BUSINESS PHONE: 770-500-3910 MAIL ADDRESS: STREET 1: 3950 JOHNS CREEK COURT STREET 2: SUITE 100 CITY: SUWANEE STATE: GA ZIP: 30024 8-K 1 ef20023361_8k.htm 8-K
 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): March 6, 2024

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 March 6, 2024, Femasys Inc. (the “Company”) issued a press release announcing completion of first in-office commercial procedure with the FDA-cleared FemaSeed infertility solution . 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 Mach 6, 2024

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: March 6, 2024
  

 
 EX-99.1 2 ef20023361_ex99-1.htm EXHIBIT 99.1
Exhibit 99.1
 
Femasys Completes the First In-Office Commercial Procedure with the FDA-Cleared FemaSeed Infertility Solution
 
-- Paving the way forward for the broader commercial availability of FemaSeed, an accessible, safe, and cost effective alternative to IVF --
 
-- Ongoing uncertainty following recent Alabama Supreme Court Ruling creates continued anticipation with top-line pivotal data expected to be announced during Q1 2024 --

ATLANTA, March 6, 2024 -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting the significant unmet needs for women worldwide with a broad portfolio of in-office, accessible and innovative therapeutic and diagnostic products, announces the first commercial procedure using its FemaSeed intratubal insemination product.
 
“FemaSeed presents an important advancement in women’s health with the availability of FemaSeed, a cost-effective and potentially safer alternative to other traditional infertility treatments,” said Femasys’ CEO Kathy Lee-Sepsick. “This first commercial application of the technology marks a pivotal moment in reshaping female infertility management, particularly in light of the recent legal rulings on frozen embryos by the Alabama Supreme Court. We are enthusiastic about expanding FemaSeed’s availability and anticipate broader acceptance within the medical community as its distinct benefits become more widely recognized.”
 
FDA-Cleared FemaSeed is a revolutionary approach to enhancing fertilization, as a cost-effective primary therapeutic choice that carries notably reduced risks compared to in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI). Engineered to precisely deliver sperm into the fallopian tube, the site of conception, FemaSeed enables reliable and safe fertilization.
 
Dr. Andrew Wagner, Women’s OB-GYN PC, Saginaw, Michigan, who completed the first in-office commercial procedure, stated, “This marks a pivotal moment for women pursuing a reliable, readily available frontline alternative for infertility. FemaSeed’s methodical delivery of sperm to the fallopian tubes, where fertilization begins, epitomizes simplicity in its sophistication, offering patients an easily understandable approach.”
 
About FemaSeed
 
FemaSeed® is an innovative infertility treatment designed to deliver sperm to the fallopian tube where conception occurs. It is intended to enhance natural fertilization and provide a first-line treatment option for those seeking pregnancy. FemaSeed is less invasive and more affordable than assisted reproduction procedures, such as IVF or ICSI. FemaSeed achieved U.S. FDA clearance (September 2023) and regulatory approval in Canada (April 2023) for patients seeking insemination. At the end of the fourth quarter of 2023, Femasys completed a pivotal clinical trial (LOCAL trial) for those seeking intratubal insemination with a specific focus on male factor infertility, a contributing factor in approximately 40-50% of infertility cases. Top-line data from this study is planned for release first quarter 2024 and will support the commercial launch targeted for the first half of 2024.

About Femasys
 
Femasys is a biomedical company focused on meeting significant unmet needs for women worldwide with a broad portfolio of in-office, accessible solutions, including a lead revolutionary product candidate and FDA-cleared, innovative therapeutic and diagnostic products. Femasys’ FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. Femasys’ FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. The Company’s diagnostic products include FemVue® for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
 
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 ability to commercialize our product candidates, or the effect of delays in commercializing; 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:
Gene Mannheimer
IR@femasys.com

Media Contact:
Kati Waldenburg
Media@femasys.com
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