[8-K] Femasys Inc. Reports Material Event

Rhea-AI Filing Summary

Femasys Inc. (NASDAQ:FEMY) filed an 8-K announcing a historic milestone with the European approval of FemBloc, their first non-surgical permanent birth control solution. This marks a significant regulatory achievement for the emerging growth company, potentially opening up the European market for their innovative medical device. The announcement was made via press release on June 25, 2025, representing a major development in the company's women's healthcare portfolio.

Positive

• First-ever European approval for non-surgical permanent birth control device
• Historic milestone achievement in women's healthcare innovation
• Potential market expansion into European territory
• Validation of company's medical device technology

Negative

• None.

Insights

Medical Device Analyst

European approval of FemBloc represents a transformative milestone for Femasys, opening significant market opportunities in women's healthcare.

The European regulatory approval for FemBloc as the first non-surgical permanent birth control solution positions Femasys at the forefront of innovation in women's reproductive health. This approval validates the technology's safety and efficacy profile while potentially addressing a significant unmet need in the contraceptive market. The non-surgical nature of FemBloc could represent a paradigm shift in permanent birth control options, potentially offering advantages in terms of procedure complexity, recovery time, and healthcare resource utilization.

Regulatory Affairs Specialist

European approval demonstrates regulatory validation and could accelerate pathway for additional market authorizations.

Securing European approval for a novel medical device like FemBloc is a significant regulatory achievement that validates Femasys's development and clinical programs. This milestone typically indicates successful completion of rigorous safety and efficacy evaluations. As an emerging growth company, this approval could serve as a reference point for other regulatory submissions globally, potentially streamlining future approval processes in other jurisdictions. The designation as the first non-surgical permanent birth control solution also suggests a unique regulatory classification that could provide certain market advantages.

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 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

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 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
99.1	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

FAQ

What is the significance of FemBloc's European approval for Femasys (FEMY)?

FemBloc's European approval represents a historic milestone as it is the first non-surgical permanent birth control solution to receive such authorization, potentially opening up significant market opportunities for Femasys in Europe.

When did Femasys (FEMY) receive European approval for FemBloc?

Femasys announced the European approval for FemBloc on June 25, 2025.

What type of company is Femasys (FEMY)?

Femasys is an emerging growth company focused on women's healthcare, specifically developing innovative medical devices like FemBloc for permanent birth control.

Who is the CEO of Femasys (FEMY)?

The CEO of Femasys is Kathy Lee-Sepsick, who signed the 8-K filing announcing the European approval.