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[8-K] Femasys Inc. Reports Material Event

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K
Rhea-AI Filing Summary

Femasys Inc. reported in a Current Report on Form 8-K that on August 20, 2025 it issued a press release announcing that the company has secured UK regulatory approval for FemBloc Permanent Birth Control. The filing states the press release is furnished as Exhibit 99.1 and is incorporated by reference into the report. The 8-K does not include further operational, commercial or financial details within the filing text provided.

Femasys Inc. ha comunicato, in un Current Report sul Modulo 8-K, che in data 20 agosto 2025 ha diffuso un comunicato stampa in cui annuncia di aver ottenuto l'approvazione regolatoria nel Regno Unito per FemBloc Permanent Birth Control. Nel documento è indicato che il comunicato è fornito come Allegato 99.1 e viene incorporato per riferimento nel rapporto. Il filing non contiene ulteriori dettagli operativi, commerciali o finanziari nel testo reso disponibile.

Femasys Inc. informó en un Current Report en el Formulario 8-K que el 20 de agosto de 2025 emitió un comunicado de prensa anunciando que la compañía obtuvo la aprobación regulatoria en el Reino Unido para FemBloc Permanent Birth Control. El informe señala que el comunicado se presenta como Exhibición 99.1 y se incorpora por referencia al reporte. El 8-K no aporta más detalles operativos, comerciales ni financieros en el texto incluido.

Femasys Inc.� Form 8-K 현재보고서에� 2025� 8� 20�� 보도자료� 통해 회사가 영국에서 FemBloc Permanent Birth Control� 규제 승인� 받았음을 발표했다� 보고했습니다. 보고서에� 해당 보도자료가 증빙자료 99.1(Exhibit 99.1)� 제공되며 보고서에 참조� 포함된다� 명시되어 있습니다. � 8-K 제출문에� 제공� 본문 내에� 추가적인 운영상·상업적·재무� 세부사항은 포함되지 않았습니�.

Femasys Inc. a indiqué dans un Current Report sur le Formulaire 8‑K que le 20 août 2025 elle a publié un communiqué de presse annonçant que la société a obtenu l'approbation réglementaire au Royaume‑Uni pour FemBloc Permanent Birth Control. Le dépôt précise que le communiqué est fourni en tant que Exhibit 99.1 et est intégré par renvoi au rapport. Le 8‑K ne contient pas d'autres éléments opérationnels, commerciaux ou financiers dans le texte fourni.

Femasys Inc. gab in einem Current Report auf Formular 8-K bekannt, dass das Unternehmen am 20. August 2025 eine Pressemitteilung veröffentlicht hat, in der es die regulatorische Zulassung im Vereinigten Königreich für FemBloc Permanent Birth Control meldet. In der Einreichung heißt es, die Pressemitteilung werde als Anlage 99.1 eingereicht und sei durch Verweis in den Bericht aufgenommen. Der 8-K enthält im vorgelegten Text keine weiteren operativen, kommerziellen oder finanziellen Angaben.

Positive
  • UK regulatory approval announced for FemBloc Permanent Birth Control
  • Press release furnished as Exhibit 99.1, making the announcement formally part of the 8-K
Negative
  • Filing contains no operational, commercial, or financial details about the approval or next steps
  • No approval documentation or timelines are included in the 8-K text; readers must consult Exhibit 99.1

Insights

TL;DR: The company confirms UK regulatory approval of FemBloc and furnishes a press release as Exhibit 99.1.

The filing explicitly states that Femasys secured regulatory approval in the United Kingdom for its FemBloc permanent birth control product and that the company issued a press release on August 20, 2025 which is attached as Exhibit 99.1. The report contains no additional regulatory documentation, approval letters, or technical details in the 8-K text itself; readers must refer to the referenced press release (Exhibit 99.1) for substantive information.

TL;DR: Material regulatory milestone announced, but the filing includes no financial or commercial detail to assess investor impact.

The Form 8-K confirms a material event—a UK regulatory approval announcement—but provides only a statement that a press release was furnished as Exhibit 99.1. The filing does not present revenue projections, commercialization plans, timing, or financial statements tied to the approval. As a result, the announcement is potentially important but the 8-K itself lacks the financial and operational data needed to quantify investor impact.

Femasys Inc. ha comunicato, in un Current Report sul Modulo 8-K, che in data 20 agosto 2025 ha diffuso un comunicato stampa in cui annuncia di aver ottenuto l'approvazione regolatoria nel Regno Unito per FemBloc Permanent Birth Control. Nel documento è indicato che il comunicato è fornito come Allegato 99.1 e viene incorporato per riferimento nel rapporto. Il filing non contiene ulteriori dettagli operativi, commerciali o finanziari nel testo reso disponibile.

Femasys Inc. informó en un Current Report en el Formulario 8-K que el 20 de agosto de 2025 emitió un comunicado de prensa anunciando que la compañía obtuvo la aprobación regulatoria en el Reino Unido para FemBloc Permanent Birth Control. El informe señala que el comunicado se presenta como Exhibición 99.1 y se incorpora por referencia al reporte. El 8-K no aporta más detalles operativos, comerciales ni financieros en el texto incluido.

Femasys Inc.� Form 8-K 현재보고서에� 2025� 8� 20�� 보도자료� 통해 회사가 영국에서 FemBloc Permanent Birth Control� 규제 승인� 받았음을 발표했다� 보고했습니다. 보고서에� 해당 보도자료가 증빙자료 99.1(Exhibit 99.1)� 제공되며 보고서에 참조� 포함된다� 명시되어 있습니다. � 8-K 제출문에� 제공� 본문 내에� 추가적인 운영상·상업적·재무� 세부사항은 포함되지 않았습니�.

Femasys Inc. a indiqué dans un Current Report sur le Formulaire 8‑K que le 20 août 2025 elle a publié un communiqué de presse annonçant que la société a obtenu l'approbation réglementaire au Royaume‑Uni pour FemBloc Permanent Birth Control. Le dépôt précise que le communiqué est fourni en tant que Exhibit 99.1 et est intégré par renvoi au rapport. Le 8‑K ne contient pas d'autres éléments opérationnels, commerciaux ou financiers dans le texte fourni.

Femasys Inc. gab in einem Current Report auf Formular 8-K bekannt, dass das Unternehmen am 20. August 2025 eine Pressemitteilung veröffentlicht hat, in der es die regulatorische Zulassung im Vereinigten Königreich für FemBloc Permanent Birth Control meldet. In der Einreichung heißt es, die Pressemitteilung werde als Anlage 99.1 eingereicht und sei durch Verweis in den Bericht aufgenommen. Der 8-K enthält im vorgelegten Text keine weiteren operativen, kommerziellen oder finanziellen Angaben.


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): August 20, 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 August 20, 2025, Femasys Inc. (the “Company”) issued a press release announcing that Femasys Secures UK Regulatory Approval of FemBloc 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 August 20, 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: August 20, 2025




FAQ

When did Femasys (FEMY) report the regulatory approval?

The Form 8-K states the company issued the press release on August 20, 2025.

What product received UK regulatory approval according to the filing?

The filing announces UK regulatory approval for FemBloc Permanent Birth Control.

Where can I find the full details of the approval announced by Femasys?

The 8-K furnishes a press release as Exhibit 99.1; the filing text does not include further details.

Does the 8-K include financial impact or commercialization plans for FemBloc?

No. The Form 8-K text provided contains no financial, commercial, or timeline details related to the approval.

What is Femasys's ticker symbol as referenced in the filing?

The filing lists the company's common stock ticker as FEMY.
FEMASYS INC

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Medical Instruments & Supplies
Surgical & Medical Instruments & Apparatus
United States
SUWANEE