FEMY 8-K
Femasys Inc (FEMY)
8-K
2025-06-25
For: 2025-06-25
View Original
Added on
July 04, 2026
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): June 25, 2025
(Exact name of registrant as specified in its charter)
|
|
|
|
|
(State or other jurisdiction of incorporation)
|
(Commission File Number)
|
(IRS Employer Identification No.)
|
|
|
|
|
|
(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
|
||
|
|
|
|
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 June 25, 2025, Femasys Inc. (the “Company”) issued a press release announcing the Historic Milestone with European Approval of FemBloc, the First Non-Surgical Permanent
Birth Control. 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 June 25, 2025.
|
|
| 104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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: June 25, 2025
|
||
Exhibit 99.1
Femasys Announces Historic Milestone with European Approval of
FemBloc®, the First Non-Surgical Permanent Birth Control
--European CE mark approval of the entire FemBloc®system marks pivotal
achievement in expanding safe, accessible and non-surgical permanent contraceptive
options for women--
ATLANTA – June 25, 2025 – Femasys Inc., (Nasdaq: FEMY), a leading biomedical innovator addressing significant unmet needs in women's health worldwide, with a broad portfolio of disruptive, accessible, in-office therapeutic and diagnostic products, announces
Conformité Européene (CE) mark certification under European Union Medical Device Regulation (EU MDR 2017/745) of the Class III FemBloc blended polymer component, marking the first regulatory approval in the world for the FemBloc® System
for non-surgical female permanent birth control. After European Medicines Agency (EMA) review, the Notified Body has granted CE mark certification. The regulatory approval for the blended polymer joins the earlier approval announced on March 13,
2025 for the delivery system component of FemBloc. The FemBloc System can now be marketed in the European Economic Area, which includes the 27 member states of the European Union and the 3 European Free Trade Association countries.
“European approval of the entire FemBloc System represents a major milestone for Femasys and the field of
women’s health. It marks the first global regulatory endorsement of our groundbreaking non-surgical permanent birth control solution, following a rigorous scientific evaluation of the technology. This achievement reflects years of dedication and
underscores our commitment to bringing safe, accessible alternatives to traditional surgical options,” stated Kathy Lee-Sepsick, Femasys’ CEO and Founder. “Femasys is preparing to make FemBloc commercially available through strategic distribution
partnerships in select countries in Europe beginning in Spain through our existing partners and will seek additional country approvals while continuing to enroll participants in our FDA IDE-approved late-stage pivotal trial for U.S. approval.”
About FemBloc
FemBloc® is a revolutionary, first-of-its-kind non-surgical solution for permanent birth control, addressing a large unmet need in women’s reproductive health.
Delivered in-office through a patented delivery system, FemBloc places a proprietary blended polymer into both fallopian tubes, which safely degrades and forms natural scar tissue to permanently block them. In contrast to surgical sterilization,
FemBloc eliminates the risks of anesthesia, infection, and recovery downtime, making it safer, more accessible, and significantly more cost-effective. With no comparable alternatives on the market, FemBloc represents a disruptive advancement with
broad global potential. Learn more at www.FemBloc.com.
About Femasys
Femasys is a leading biomedical innovator focused on addressing critical unmet needs in women’s health with a broad, patent-protected portfolio of disruptive, accessible,
in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes
FemaSeed® Intratubal Insemination, a groundbreaking first-line infertility treatment and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data show FemaSeed is over twice as effective as
traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.1
FemBloc® permanent birth control, the first and only non-surgical, in-office alternative to centuries-old surgical sterilization, has received regulatory
approval in Europe. Commercialization of this highly cost effective, convenient and significantly safer approach will begin in Spain through engaged partnerships followed by select European countries. Alongside FemBloc, the FemChec® is a
diagnostic product that enables an ultrasound-based test to confirm procedure success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction.2 For
U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is ongoing.
Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
References
1Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal
Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08.
2Liu, J. H., Blumenthal, P. D., Castaño, P. M., Chudnoff, S. C., Gawron, L. M., Johnstone, E. B.,
Lee-Sepsick, K. (2025). FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes. J Gynecol Reprod Med, 9(1), 01-12. doi: 10.33140/JGRM.09.01.05.
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,” “suggests,” “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 obtain regulatory approvals for our FemBloc product candidate; develop and advance our current FemBloc product candidate and successfully enroll and complete the clinical trial; the ability of our clinical trial to
demonstrate safety and effectiveness of our product candidate and other positive results; estimates regarding the total addressable market for our products and product candidate; our ability to commercialize our products and product candidate, our
ability to establish, maintain, grow or increase sales and revenues, or the effect of delays in commercializing our products, including FemaSeed; 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, 2024, 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:
Media Contact: