Femasys Secures UK Regulatory Approval of FemBloc Permanent Birth Control
Femasys Inc. (NASDAQ: FEMY) has secured MHRA approval for its FemBloc Permanent Birth Control in the United Kingdom, following its recent CE mark approval for Europe. This regulatory milestone validates the product's safety, quality, and effectiveness standards for the UK market.
FemBloc represents a revolutionary non-surgical permanent birth control solution that utilizes a patented delivery system to place a proprietary blended polymer in the fallopian tubes. The polymer naturally degrades and forms scar tissue for permanent occlusion, offering significant advantages over surgical sterilization by eliminating anesthesia risks, infection concerns, and recovery time.
The UK approval positions Femasys to pursue strategic partnerships for commercialization in one of Europe's largest healthcare markets, particularly through the National Health Service (NHS).
Femasys Inc. (NASDAQ: FEMY) ha ottenuto l'approvazione MHRA per il suo FemBloc Permanent Birth Control nel Regno Unito, a seguito della recente marcatura CE per l'Europa. Questo traguardo normativo conferma che il prodotto soddisfa gli standard di sicurezza, qualità ed efficacia per il mercato britannico.
FemBloc è una soluzione rivoluzionaria di contraccezione permanente non chirurgica che impiega un sistema di somministrazione brevettato per collocare un polimero proprietario nei tubi di Falloppio. Il polimero si degrada naturalmente e induce la formazione di tessuto cicatriziale che determina l’occlusione permanente, offrendo vantaggi rilevanti rispetto alla sterilizzazione chirurgica eliminando i rischi legati all’anestesia, le infezioni e i tempi di recupero.
L'approvazione nel Regno Unito posiziona Femasys per cercare partnership strategiche per la commercializzazione in uno dei maggiori mercati sanitari europei, in particolare tramite il National Health Service (NHS).
Femasys Inc. (NASDAQ: FEMY) ha obtenido la aprobación de la MHRA para su FemBloc Permanent Birth Control en el Reino Unido, tras la reciente certificación CE para Europa. Este hito regulatorio valida que el producto cumple los estándares de seguridad, calidad y eficacia para el mercado británico.
FemBloc representa una innovadora solución permanente de control de la natalidad no quirúrgica que utiliza un sistema de administración patentado para colocar un polímero de fórmula propia en las trompas de Falopio. El polímero se degrada de forma natural y promueve la formación de tejido cicatricial que produce una oclusión permanente, ofreciendo ventajas importantes frente a la esterilización quirúrgica al eliminar los riesgos de anestesia, las infecciones y el tiempo de recuperación.
La aprobación en el Reino Unido sitúa a Femasys en posición de buscar alianzas estratégicas para la comercialización en uno de los mayores mercados sanitarios de Europa, especialmente a través del National Health Service (NHS).
Femasys Inc. (NASDAQ: FEMY)가 최근 유럽 CE 인증에 이어 영국에서 자사의 FemBloc Permanent Birth Control에 대해 MHRA 승인을 획득했습니다. 이번 규제 승인으로 해당 제품이 영국 시장의 안전성, 품질 및 유효성 기준을 충족함이 확인되었습니다.
FemBloc는 특허받은 전달 시스템을 이용해 난관에 독자적인 혼합 폴리머를 삽입하는 혁신적인 비수술적 영구 피임 솔루션입니다. 이 폴리머는 자연 분해되며 흉터 조직을 형성해 영구 폐색을 유도하므로, 마취 위험, 감염 및 회복 시간 등 수술적 불임 시술의 단점을 해소하는 중요한 이점을 제공합니다.
영국 승인으로 Femasys는 국가보건서비스(NHS)를 포함한 유럽 최대 의료 시장 중 하나에서의 상업화 파트너십을 모색할 수 있는 유리한 위치에 서게 되었습니다.
Femasys Inc. (NASDAQ: FEMY) a obtenu l'approbation de la MHRA pour son FemBloc Permanent Birth Control au Royaume-Uni, suite à la récente obtention du marquage CE pour l'Europe. Cette étape réglementaire confirme que le produit répond aux normes de sécurité, de qualité et d'efficacité pour le marché britannique.
FemBloc est une solution révolutionnaire de qui utilise un système d'administration breveté pour déposer un polymère exclusif dans les trompes de Fallope. Le polymère se dégrade naturellement et favorise la formation de tissu cicatriciel entraînant une occlusion permanente, offrant des avantages significatifs par rapport à la stérilisation chirurgicale en éliminant les risques liés à l'anesthésie, les infections et le temps de récupération.
Cette approbation au Royaume-Uni place Femasys en position de rechercher des partenariats stratégiques pour la commercialisation dans l'un des plus grands marchés de santé européens, notamment via le National Health Service (NHS).
Femasys Inc. (NASDAQ: FEMY) hat für sein FemBloc Permanent Birth Control in Großbritannien eine MHRA-Zulassung erhalten, nachdem kürzlich die CE-Kennzeichnung für Europa erteilt wurde. Dieser regulatorische Meilenstein bestätigt, dass das Produkt die Sicherheits-, Qualitäts- und Wirksamkeitsanforderungen für den britischen Markt erfüllt.
FemBloc ist eine revolutionäre nicht-chirurgische dauerhafte Verhütungsoption, die ein patentiertes Applikationssystem verwendet, um ein firmeneigenes Mischpolymer in die Eileiter zu platzieren. Das Polymer baut sich natürlich ab und führt zur Bildung von Narbengewebe, das eine dauerhafte Okklusion bewirkt. Dadurch bietet es wesentliche Vorteile gegenüber chirurgischer Sterilisation, da Risiken durch Anästhesie, Infektionen und Erholungszeiten entfallen.
Die Zulassung in Großbritannien versetzt Femasys in die Lage, strategische Partnerschaften für die Kommerzialisierung in einem der größten Gesundheitsmärkte Europas anzustreben, insbesondere über den National Health Service (NHS).
- Secured MHRA approval in the UK market, following recent CE mark approval for Europe
- First-of-its-kind non-surgical permanent birth control solution with no direct market competitors
- Potential for broad adoption through UK's National Health Service (NHS)
- More cost-effective and safer alternative to surgical sterilization
- Strategic partner still needed for UK commercialization
- Market penetration and adoption timeline uncertain
Insights
Femasys' UK regulatory approval for FemBloc permanent birth control strengthens its European expansion following CE mark, creating significant market opportunities.
The MHRA approval for Femasys' FemBloc permanent birth control system represents a significant regulatory milestone that validates the product's safety and efficacy standards in one of Europe's most influential healthcare markets. This approval follows the recent CE mark certification, creating a clear regulatory pathway for European commercialization.
FemBloc's innovative approach offers substantial advantages over traditional surgical sterilization methods. By utilizing a proprietary blended polymer delivered through a patented system, it induces natural scar tissue formation in the fallopian tubes without surgery. This eliminates major risks associated with surgical sterilization including anesthesia complications, infections, and recovery downtime.
The UK approval is particularly valuable given the National Health Service's (NHS) single-payer structure, which favors cost-effective innovations that improve accessibility. For Femasys, this creates a strategic advantage in securing NHS adoption, potentially leading to widespread implementation across the UK healthcare system.
The company's stated intention to secure a strategic partner for UK commercialization suggests they recognize the need for local market expertise and distribution capabilities. This pragmatic approach could accelerate market penetration while optimizing resource allocation.
With no comparable non-surgical permanent birth control alternatives currently available, FemBloc addresses a substantial market gap in women's reproductive health. The combination of regulatory validations (CE mark and now MHRA approval) positions Femasys to potentially transform the permanent contraception landscape in Europe, providing women with a safer, more accessible alternative to surgical sterilization.
--Advances European commercialization strategy following CE mark approval--
ATLANTA, Aug. 20, 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 that it received the Medicines and Healthcare products Regulatory Agency (MHRA) approval for its FemBloc Permanent Birth Control, which signifies the product has met the required standards for safety, quality, and effectiveness in the United Kingdom (UK). This marks an important milestone in the Company’s efforts to expand availability of this revolutionary non-surgical permanent birth control option to women in Europe.
“The UK’s regulatory approval for FemBloc permanent birth control is another milestone in our global expansion strategy,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “This follows our recent CE mark for Europe and reinforces our momentum toward broader international market access. This achievement demonstrates regulatory confidence in our technology and positions us to move forward with securing a strategic partner to support commercialization in the UK.”
The United Kingdom represents one of the largest and most influential healthcare markets in Europe, with a strong emphasis on advancing women’s health solutions. With the UK’s single-payer National Health Service (NHS), innovative technologies that improve access, reduce costs, and enhance outcomes have a clear pathway to broad adoption. Securing MHRA approval not only validates FemBloc’s safety and effectiveness but also enables Femasys to serve a diverse patient population in this critical market.
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. 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 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. 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:
Investors:
IR@femasys.com
Media Contact:
Media@femasys.com
FAQ
What regulatory approval did Femasys (NASDAQ: FEMY) receive for FemBloc in August 2025?
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