Femasys Announces Initiation of Post-Market Surveillance Study for FemBloc® Permanent Birth Control in Europe
Femasys (NASDAQ: FEMY) announced the initiation of a post-market surveillance (PMS) clinical study for its CE-marked FemBloc Permanent Birth Control in Europe on October 22, 2025.
The study is conducted under the EU Medical Device Regulation (EU MDR 2017/745, Annex XIV Part B), has approval from multiple Ethics Committees, and follows ISO 14155:2020 Good Clinical Practice and applicable national rules. FemBloc is described as a non-surgical permanent birth control using a biodegradable polymer delivery to occlude fallopian tubes without anesthesia, incisions, or recovery time, positioned to support physician adoption and reimbursement across Europe.
Femasys (NASDAQ: FEMY) ha annunciato l'inizio di una studio clinico di sorveglianza post-marketing (PMS) per il suo FemBloc Permanent Birth Control, certificato CE, in Europa il 22 ottobre 2025.
Lo studio è condotto secondo il Regolamento sui dispositivi medici dell'UE (EU MDR 2017/745, Allegato XIV Parte B), ha l'approvazione da parte di numerosi Comitati Etici e segue la ISO 14155:2020 Good Clinical Practice e le normative nazionali applicabili. FemBloc è descritto come una contraccezione permanente non chirurgica che utilizza una somministrazione di polimero biodegradabile per ostruire le tube di Falloppio senza anestesia, incisioni o tempo di recupero, posizionato per supportare l'adozione da parte dei medici e il rimborso in tutta l'Europa.
Femasys (NASDAQ: FEMY) anunció el inicio de un estudio clínico de vigilancia postcomercialización (PMS) para su FemBloc Permanent Birth Control con certificación CE en Europa el 22 de octubre de 2025.
El estudio se realiza bajo el Reglamento de Dispositivos Médicos de la UE (EU MDR 2017/745, Anexo XIV Parte B), cuenta con la aprobación de múltiples Comités de Ética y sigue las buenas prácticas clínicas ISO 14155:2020 y las normas nacionales aplicables. FemBloc se describe como una control de natalidad permanente no quirúrgico que utiliza una entrega de polímeros biodegradables para ocluir las trompas de Falopio sin anestesia, incisiones o tiempo de recuperación, diseñado para apoyar la adopción por parte de los médicos y el reembolso en toda Europa.
Femasys (NASDAQ: FEMY)는 2025년 10월 22일 유럽에서 CE 인증 FemBloc Permanent Birth Control의 시장 후 surveillance(PMS) 임상 연구의 시작을 발표했습니다.
본 연구는 EU 의료기기 규정(EU MDR 2017/745, 부속 XIV, Part B)에 따라 수행되며, 여러 윤리위원회의 승인을 받았고 ISO 14155:2020의 우수 임상 실무 및 해당 국내 규정을 준수합니다. FemBloc은 비수술적 영구 피임으로, 생분해성 폴리머 전달 방식으로 난관을 막아 마취, 절개 또는 회복 시간을 필요로 하지 않도록 설계되어, 의사 채택과 유럽 전역의 상환을 지원하도록 위치화되어 있습니다.
Femasys (NASDAQ : FEMY) a annoncé le démarrage d'une étude clinique de surveillance post-commercialisation (PMS) pour son contrôle des naissances permanent FemBloc certifié CE en Europe le 22 octobre 2025.
L'étude est menée conformément au Règlement relatif aux dispositifs médicaux de l'UE (EU MDR 2017/745, Annexe XIV Partie B), bénéficie de l'approbation de plusieurs comités d'éthique et suit les bonnes pratiques cliniques ISO 14155:2020 et les règles nationales applicables. FemBloc est décrit comme une contraception permanente non chirurgicale utilisant une délivrance de polymère biodégradable pour occlure les trompes sans anesthésie, incisions ou temps de récupération, positionné pour soutenir l'adoption par les médecins et le remboursement à travers l'Europe.
Femasys (NASDAQ: FEMY) hat den Start einer Post-Market Surveillance (PMS)-klinischen Studie für seine CE-zertifizierte FemBloc Permanente Empfängnisverhütung in Europa am 22. Oktober 2025 bekannt gegeben.
Die Studie erfolgt gemäß der EU-Medizinprodukte-Verordnung (EU MDR 2017/745, Anhang XIV Teil B), hat die Zustimmung mehrerer Ethikkommissionen und folgt die ISO 14155:2020 Gute Klinische Praxis und den geltenden nationalen Vorschriften. FemBloc wird als eine nicht-chirurgische permanente Empfängnisverhütung beschrieben, die eine Abgabe eines bioabbaubaren Polymers verwendet, um die Eileiter zu verschließen, ohne Anästhesie, Schnitte oder Erholungszeit, positioniert, um die Annahme durch Ärzte und Erstattung in ganz Europa zu unterstützen.
Femasys (NASDAQ: FEMY) أعلنت عن بدء دراسة سريرية للمراقبة بعد التسويق PMS لوسيطها CE FemBloc Permanent Birth Control في أوروبا في 22 أكتوبر 2025.
تتم الدراسة بموجب لوائح الأجهزة الطبية في الاتحاد الأوروبي (EU MDR 2017/745، الملحق XIV جز B)، وتحظى بموافقة عدة لجان أخلاقية وتتبع ISO 14155:2020 الممارسات السريرية الجيدة واللوائح الوطنية المعمول بها. يوصف FemBloc بأنه وسيلة منع حمل دائمة غير جراحية تستخدم إسقاط بوليمري قابل للتحلل لمنع قنوات فالوب دون تخدير أو جروح أو وقت نقاهة، كما يتم وضعه لدعم اعتماد الأطباء والتغطية في كامل أوروبا.
Femasys (NASDAQ: FEMY)宣布于2025年10月22日在欧洲启动其CE认证的 FemBloc Permanent Birth Control的 市场后监测（PMS）临床研究。
该研究在 欧盟医疗器械法规（EU MDR 2017/745，附录 XIV Part B）下进行，已获得多个伦理委员会批准，并遵循 ISO 14155:2020 的良好临床实践和适用的国家法规。FemBloc 被描述为一项 非手术的永久性避孕，使用可生物降解聚合物递送以阻塞输卵管，无需麻醉、切口或恢复期，旨在支持欧洲各国医生的采用和报销。
- CE-marked FemBloc product in European market
- Initiated PMS study under EU MDR on Oct 22, 2025
- PMS study approved by multiple Ethics Committees
- Study conducted per ISO 14155:2020 Good Clinical Practice
- None.
Insights
Initiation of a CE‑region post‑market surveillance study advances regulatory compliance and supports European commercialization for FemBloc.
Femasys has started a post‑market surveillance (PMS) study under EU MDR 2017/745 and Annex XIV Part B, with Ethics Committee approvals and ISO 14155:2020 alignment, which formally documents safety and performance in real‑world use. This step completes a regulatory obligation and supplies structured clinical evidence required to maintain CE conformity while informing clinicians and payors about device outcomes.
The outcome depends on the study’s design, data quality, and enrollment pace; risks include adverse event findings or insufficient real‑world effectiveness that could slow adoption or reimbursement discussion. Monitor protocol endpoints, sample size, follow‑up duration and interim safety signals; expect initial data and regulatory updates within the next 12–24 months around enrollment milestones and interim analyses.
--Marks key milestone in European commercialization strategy under EU Medical Device Regulation (MDR)--
ATLANTA, Oct. 22, 2025 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced the commencement of a post-market surveillance (PMS) clinical study for its CE-marked FemBloc Permanent Birth Control. This study is being conducted in accordance with the European Union Medical Device Regulation (EU MDR 2017/745) and numerous thought leaders throughout the region.
This PMS study is a key component of Femasys’ long-term commitment to monitor the safety and performance of its products in real-world settings while complying with the rigorous post-market requirements introduced under the MDR framework (Annex XIV Part B). The study has received approval from multiple Ethics Committees and is being carried out in compliance with ISO 14155:2020 for Good Clinical Practice and applicable national regulations.
“Launching this post-market study is a significant milestone in advancing our European commercialization strategy for FemBloc,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “By generating real-world data, we are not only meeting stringent MDR requirements but also building the foundation for broader physician adoption and reimbursement. With strong demand among women in Europe for safe, accessible permanent birth control, FemBloc is uniquely positioned to address this unmet need and drive meaningful growth as we expand access to women worldwide.”
FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control, addressing a significant unmet need in women’s reproductive health. It uses a patented delivery system to place a proprietary blended polymer into both fallopian tubes, which safely degrades and forms natural scar tissue for permanent occlusion. Unlike surgical sterilization, FemBloc requires no anesthesia, no incisions, and no recovery time, avoiding the risks of infection and other surgical complications while providing women a safer, more convenient, and affordable option. 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 making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, 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-step infertility treatment and FemVue®, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates 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 is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June of 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec®, diagnostic product provides an ultrasound-based test to confirm procedural 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 on-going.
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:
David Gutierrez, Dresner Corporate Services, (312) 780-7204, dgutierrez@dresnerco.com
Nathan Abler, Dresner Corporate Services, (714) 742-4180, nabler@dresnerco.com
FAQ
What did Femasys (FEMY) announce on October 22, 2025 about FemBloc in Europe?
How does the FemBloc PMS study comply with European rules for FEMY's device?
What is FemBloc and how does it differ from surgical sterilization (FEMY)?
Will the FemBloc PMS study affect reimbursement and physician adoption for FEMY in Europe?
Is FemBloc already approved for sale in Europe under FEMY stock symbol?
