Femasys Announces Historic Milestone with European Approval of FemBloc®, the First Non-Surgical Permanent Birth Control
Femasys (NASDAQ:FEMY) has achieved a historic milestone with the European CE mark approval for its FemBloc® System, the world's first non-surgical permanent birth control solution. The Class III FemBloc blended polymer component received certification under EU MDR 2017/745, following the earlier approval of its delivery system component in March 2025.
The FemBloc System can now be marketed across the European Economic Area, including 27 EU member states and 3 European Free Trade Association countries. The company plans to launch commercial distribution initially in Spain through existing partners while pursuing additional country approvals and continuing its FDA IDE-approved pivotal trial for U.S. approval.
Femasys (NASDAQ:FEMY) ha raggiunto un traguardo storico con l'approvazione del marchio CE europeo per il suo FemBloc® System, la prima soluzione permanente di controllo delle nascite non chirurgica al mondo. Il componente in polimero composito di Classe III FemBloc ha ottenuto la certificazione secondo il Regolamento UE MDR 2017/745, dopo l'approvazione precedente del componente del sistema di somministrazione nel marzo 2025.
Il FemBloc System può ora essere commercializzato in tutto lo Spazio Economico Europeo, che comprende 27 stati membri dell'UE e 3 paesi dell'Associazione Europea di Libero Scambio. L'azienda prevede di avviare la distribuzione commerciale inizialmente in Spagna tramite partner esistenti, mentre continua a richiedere approvazioni in altri paesi e porta avanti il suo studio cardine approvato dalla FDA IDE per l'approvazione negli Stati Uniti.
Femasys (NASDAQ:FEMY) ha alcanzado un hito histórico con la aprobación del marcado CE europeo para su sistema FemBloc®, la primera solución permanente de control de natalidad no quirúrgica en el mundo. El componente polimérico compuesto de Clase III FemBloc recibió la certificación bajo el MDR de la UE 2017/745, tras la aprobación previa de su componente del sistema de entrega en marzo de 2025.
El sistema FemBloc ahora puede comercializarse en todo el Área Económica Europea, que incluye 27 estados miembros de la UE y 3 países de la Asociación Europea de Libre Comercio. La compañía planea lanzar la distribución comercial inicialmente en España a través de socios existentes, mientras busca aprobaciones adicionales en otros países y continúa con su ensayo pivotal aprobado por la FDA IDE para la aprobación en EE. UU.
Femasys (NASDAQ:FEMY)는 세계 최초의 비수술적 영구 피임 솔루션인 FemBloc® 시스템에 대해 유럽 CE 인증을 획득하는 역사적인 이정표를 달성했습니다. 클래스 III FemBloc 복합 고분자 부품은 2025년 3월에 이미 승인된 전달 시스템 부품에 이어 EU MDR 2017/745에 따라 인증을 받았습니다.
FemBloc 시스템은 이제 27개의 EU 회원국과 3개의 유럽 자유무역연합 국가를 포함하는 유럽 경제 지역 전역에서 판매될 수 있습니다. 회사는 기존 파트너를 통해 처음으로 스페인에서 상업적 유통을 시작할 계획이며, 추가 국가 승인 절차를 진행하는 한편 FDA IDE 승인 핵심 임상시험도 계속 진행 중입니다.
Femasys (NASDAQ:FEMY) a franchi une étape historique avec l'approbation du marquage CE européen pour son système FemBloc®, la première solution permanente de contraception non chirurgicale au monde. Le composant polymère composite de classe III FemBloc a reçu la certification selon le règlement européen MDR 2017/745, suite à l'approbation antérieure de son composant du système de livraison en mars 2025.
Le système FemBloc peut désormais être commercialisé dans tout l'Espace économique européen, comprenant 27 États membres de l'UE et 3 pays de l'Association européenne de libre-échange. L'entreprise prévoit de lancer la distribution commerciale initialement en Espagne via des partenaires existants, tout en poursuivant les approbations dans d'autres pays et en continuant son essai pivot approuvé par la FDA IDE pour l'approbation aux États-Unis.
Femasys (NASDAQ:FEMY) hat einen historischen Meilenstein erreicht mit der europäischen CE-Kennzeichnung für sein FemBloc® System, die weltweit erste nicht-chirurgische dauerhafte Verhütungslösung. Die Klasse-III FemBloc Verbundpolymer-Komponente erhielt die Zertifizierung gemäß EU-MDR 2017/745, nachdem zuvor im März 2025 die Zulassung der Lieferkomponente erfolgte.
Das FemBloc System kann nun im gesamten Europäischen Wirtschaftsraum vermarktet werden, einschließlich 27 EU-Mitgliedstaaten und 3 Ländern des Europäischen Freihandelsverbands. Das Unternehmen plant, den kommerziellen Vertrieb zunächst in Spanien über bestehende Partner zu starten, während es weitere Länderzulassungen anstrebt und seine von der FDA IDE genehmigte Schlüsselstudie für die Zulassung in den USA fortsetzt.
- First-ever regulatory approval worldwide for non-surgical permanent birth control system
- Secured CE mark certification for entire FemBloc System in European Economic Area (30 countries)
- Commercial launch planned in Spain through existing partnerships
- Ongoing FDA IDE-approved late-stage pivotal trial for potential U.S. approval
- None.
Insights
Femasys achieves groundbreaking European approval for FemBloc non-surgical permanent birth control, opening significant commercial opportunities ahead of US trials.
Femasys has secured a historic regulatory milestone with CE mark certification under EU MDR 2017/745 for its Class III FemBloc blended polymer component. This marks the first regulatory approval worldwide for the complete FemBloc System, creating a new category in permanent contraception as the first non-surgical alternative to traditional procedures like tubal ligation.
The significance of this approval cannot be overstated. Class III medical devices face the most rigorous regulatory scrutiny in Europe, requiring comprehensive clinical evidence and risk management documentation. The FemBloc System received approval following European Medicines Agency review and Notified Body certification, validating the technology's safety and efficacy profile.
This approval grants Femasys immediate marketing authorization across 30 European countries (27 EU member states plus 3 EFTA countries), representing a substantial market opportunity. The company's strategic approach—beginning commercialization in Spain through existing distribution partnerships while pursuing additional country approvals—demonstrates a thoughtful market entry strategy.
Meanwhile, Femasys continues to advance its FDA IDE-approved pivotal trial in the United States, pursuing a dual-continent strategy that could eventually position FemBloc as a global option in permanent contraception. If the clinical trial demonstrates comparable safety and efficacy to surgical alternatives, FemBloc could potentially disrupt the permanent birth control market by offering a less invasive, more accessible option performed in an office setting rather than requiring surgery.
--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 (GLOBE NEWSWIRE) -- 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:
IR@femasys.com
Media Contact:
Media@femasys.com
FAQ
What is the significance of Femasys (FEMY) receiving CE mark approval for FemBloc?
When will Femasys (FEMY) launch FemBloc in Europe?
What is the current status of FemBloc's FDA approval process?
Which countries are included in FemBloc's European approval?
What components of the FemBloc system received CE mark approval?
