Femasys Secures Regulatory Approval for 贵别尘叠濒辞肠庐 Permanent Birth Control in New Zealand
Femasys (NASDAQ: FEMY) has secured regulatory approval from New Zealand's MEDSAFE for 贵别尘叠濒辞肠庐, its innovative non-surgical permanent birth control solution. This milestone follows recent approvals in Europe (CE Mark) and the UK, marking the company's entry into the Asia-Pacific region.
贵别尘叠濒辞肠庐 is a first-of-its-kind technology that uses a proprietary blended polymer delivery system to create permanent fallopian tube occlusion through natural scar tissue formation. The solution eliminates risks associated with surgical sterilization, including anesthesia complications and infection, while offering a more cost-effective and accessible option for women seeking permanent birth control.
Femasys (NASDAQ: FEMY) ha ottenuto l'approvazione regolatoria da MEDSAFE della Nuova Zelanda per 贵别尘叠濒辞肠庐, la sua innovativa soluzione permanente di contraccezione non chirurgica. Questo traguardo segue le recenti autorizzazioni in Europa (Marchio CE) e nel Regno Unito, segnando l'ingresso dell'azienda nella regione Asia-Pacifico.
贵别尘叠濒辞肠庐 猫 una tecnologia senza precedenti che impiega un sistema proprietario di rilascio a base di polimeri miscelati per provocare l'occlusione permanente delle tube di Falloppio mediante la formazione naturale di tessuto cicatriziale. La soluzione elimina i rischi legati alla sterilizzazione chirurgica, come complicazioni legate all'anestesia e infezioni, offrendo al contempo un'opzione pi霉 economica e accessibile per le donne che desiderano una contraccezione permanente.
Femasys (NASDAQ: FEMY) ha obtenido la aprobaci贸n regulatoria de MEDSAFE de Nueva Zelanda para 贵别尘叠濒辞肠庐, su innovadora soluci贸n permanente de anticoncepci贸n no quir煤rgica. Este hito se suma a las aprobaciones recientes en Europa (marcado CE) y el Reino Unido, y marca la entrada de la compa帽铆a en la regi贸n de Asia-Pac铆fico.
贵别尘叠濒辞肠庐 es una tecnolog铆a pionera que utiliza un sistema de liberaci贸n patentado de pol铆meros mezclados para lograr la oclusi贸n permanente de las trompas de Falopio mediante la formaci贸n natural de tejido cicatricial. La soluci贸n elimina los riesgos asociados a la esterilizaci贸n quir煤rgica, incluidas las complicaciones de la anestesia y las infecciones, y ofrece una opci贸n m谩s econ贸mica y accesible para las mujeres que buscan anticoncepci贸n permanente.
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贵别尘叠濒辞肠庐電� 順柬暕 韽措Μ毹� 鞝勲嫭 鞁滌姢韰滌潉 霃呾瀽鞝侅溂搿� 頇滌毄頃� 鞛愳棸 頋夗劙 臁办 順曥劚鞚� 韱淀暣 雮滉磤鞚� 鞓侁惮 氪夓噭頃橂姅 靹戈硠 斓滌磮鞚� 旮办垹鞛呺媹雼�. 鞚� 靻旊（靺橃潃 毵堨法 頃╇硲歃濎澊雮� 臧愳椉 霌� 靾橃垹鞝� 攵堨瀯 鞁滌垹瓿� 甏�霠悳 鞙勴棙鞚� 鞝滉卑頃橂┌, 鞓侁惮 頂检瀯鞚� 鞗愴晿電� 鞐劚霌れ棎瓴� 雿� 牍勳毄 須湪鞝侅澊瓿� 鞝戧芳 臧�電ロ暅 靹犿儩歆�毳� 鞝滉车頃╇媹雼�.
Femasys (NASDAQ: FEMY) a obtenu l'approbation r茅glementaire de MEDSAFE en Nouvelle-Z茅lande pour 贵别尘叠濒辞肠庐, sa solution innovante de contraception permanente non chirurgicale. Cette 茅tape fait suite aux r茅centes autorisations en Europe (marquage CE) et au Royaume-Uni, et marque l'entr茅e de la soci茅t茅 dans la r茅gion Asie-Pacifique.
贵别尘叠濒辞肠庐 est une technologie in茅dite qui utilise un syst猫me propri茅taire d'administration de polym猫res m茅lang茅s pour provoquer l'occlusion permanente des trompes de Fallope par formation naturelle de tissu cicatriciel. Cette solution supprime les risques li茅s 脿 la st茅rilisation chirurgicale, notamment les complications anesth茅siques et les infections, tout en offrant une option plus 茅conomique et plus accessible aux femmes souhaitant une contraception permanente.
Femasys (NASDAQ: FEMY) hat von MEDSAFE in Neuseeland die Zulassung f眉r 贵别尘叠濒辞肠庐 erhalten, seine innovative nicht-chirurgische, dauerhafte Verh眉tungsl枚sung. Dieser Meilenstein folgt den j眉ngsten Zulassungen in Europa (CE-Kennzeichnung) und im Vereinigten K枚nigreich und markiert den Eintritt des Unternehmens in die Region Asien-Pazifik.
贵别尘叠濒辞肠庐 ist eine einmalige Technologie, die ein propriet盲res, gemischtes Polymer-Abgabesystem nutzt, um durch nat眉rliche Narbenbildung eine dauerhafte Verschlussung der Eileiter zu erreichen. Die L枚sung eliminiert Risiken, die mit chirurgischer Sterilisation verbunden sind, darunter Komplikationen durch An盲sthesie und Infektionen, und bietet Frauen, die eine dauerhafte Empf盲ngnisverh眉tung w眉nschen, eine kosteng眉nstigere und besser zug盲ngliche Option.
- Secured MEDSAFE regulatory approval in New Zealand, expanding into Asia-Pacific market
- Recent regulatory approvals in Europe (CE Mark) and UK demonstrate growing regulatory confidence
- First-of-its-kind non-surgical permanent birth control with no comparable alternatives
- Eliminates surgical risks and reduces healthcare costs compared to traditional sterilization
- None.
Insights
Femasys gains New Zealand approval for FemBloc, expanding global reach for their non-surgical permanent birth control following European successes.
Femasys has secured a strategic regulatory win with New Zealand MEDSAFE approval for FemBloc, their non-surgical permanent birth control solution. This approval represents their first entry into the Asia-Pacific region, building momentum after recent authorizations in Europe (CE Mark) and the UK. The sequential regulatory clearances demonstrate growing international confidence in the technology's safety and efficacy profile.
The approval is particularly significant in New Zealand's healthcare landscape, where the public funding system favors cost-effective innovations that improve outcomes. FemBloc's non-surgical approach eliminates risks associated with traditional surgical sterilization including anesthesia complications, infections, and extended recovery periods. This positions the product favorably for adoption within New Zealand's healthcare framework, which emphasizes women's health access.
From a regulatory strategy perspective, Femasys appears to be executing a methodical global rollout, securing approvals in smaller but sophisticated regulatory environments before potentially tackling larger markets. This approach allows the company to build a safety record and real-world evidence while generating revenue. The New Zealand approval likely required comprehensive safety and efficacy data, and successful clearance suggests the product's documentation and clinical evidence meet international standards.
The company's innovative technology, which uses a proprietary blended polymer that degrades naturally and forms occlusive scar tissue in the fallopian tubes, addresses a significant gap in the permanent birth control market following the discontinuation of previous non-surgical options due to safety concerns.
This MEDSAFE approval strengthens Femasys' position in the $10+ billion global contraceptive market, specifically in the permanent birth control segment where options have been limited. The company's strategic expansion into New Zealand鈥攁 relatively small market with approximately 1 million women of reproductive age鈥攊s more significant than raw numbers suggest.
New Zealand serves as an ideal early-adoption market with several advantages: a centralized healthcare system enabling faster nationwide rollout, a progressive stance on women's health innovations, and potential to influence neighboring Australia and other Asia-Pacific markets. This approval creates a valuable reference point for future regulatory submissions in larger APAC countries.
FemBloc addresses critical market gaps left when Essure (the previous non-surgical option) was withdrawn due to safety concerns. The product's unique value proposition combines non-surgical convenience with cost-effectiveness鈥攑articularly important in publicly funded healthcare systems where procedural savings and reduced complications translate to significant economic benefits.
The sequential regulatory strategy (CE Mark, UK, now New Zealand) suggests Femasys is building a strategic pathway toward larger markets while generating revenue and clinical experience. This approach allows for controlled commercialization, refinement of training protocols, and accumulation of real-world data to support subsequent applications in major markets.
While immediate revenue impact from New Zealand will be modest, the cumulative effect of multiple international approvals strengthens Femasys' negotiating position with potential distribution partners and demonstrates commercial viability to investors. The company is effectively executing a measured global rollout strategy that balances near-term revenue generation with strategic positioning for larger market opportunities.
Expands international footprint with entry into Asia-Pacific, building on recent CE Mark and UK approvals
ATLANTA, Sept. 08, 2025 (GLOBE NEWSWIRE) -- (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced it has received approval from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for its FemBloc Permanent Birth Control. This approval confirms that FemBloc meets the country鈥檚 standards for safety, quality, and effectiveness, and represents an important milestone in Femasys鈥� global expansion strategy to make this revolutionary non-surgical permanent birth control option available to women worldwide.
鈥淢EDSAFE鈥檚 regulatory approval of FemBloc permanent birth control represents another key step in broadening international market access to our innovative technology,鈥� said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. 鈥淏uilding on our recent CE Mark in Europe and approval in the UK, this accomplishment reflects growing regulatory confidence in our technology, and strengthens our focus on securing additional country approvals.鈥�
New Zealand represents a strategically important healthcare market in the Asia-Pacific region, with a strong focus on advancing women鈥檚 health and equitable access to innovative treatments. Under its publicly funded healthcare system, technologies that improve outcomes and reduce costs have a clear pathway to adoption. Securing MEDSAFE approval not only validates FemBloc鈥檚 safety and effectiveness but also enables Femasys to provide women in New Zealand with access to a groundbreaking, non-surgical permanent birth control option.
FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control, addressing a significant unmet need in women鈥檚 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 .
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鈥� fertility portfolio includes FemaSeed庐 Intratubal Insemination, a groundbreaking first-step infertility treatment and FemVue庐, 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庐 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庐, 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.
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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., Casta帽o, 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聽
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 鈥渕ay,鈥� 鈥渨ill,鈥� 鈥渟hould,鈥� 鈥渆xpect,鈥� 鈥減lan,鈥� 鈥渁nticipate,鈥� 鈥渃ould,鈥� 鈥減ending,鈥� 鈥渋ntend,鈥� 鈥渂elieve,鈥� 鈥渟uggests,鈥� 鈥減otential,鈥� 鈥渉ope,鈥� or 鈥渃ontinue鈥� 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.聽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.
颁辞苍迟补肠迟蝉:听
David Gutierrez, Dresner Corporate Services, (312) 780-7204,
Nathan Abler, Dresner Corporate Services, (714) 742-4180,
FAQ
What regulatory approval did Femasys (NASDAQ: FEMY) receive for FemBloc in September 2025?
How does FemBloc permanent birth control work?
What advantages does FemBloc offer compared to surgical sterilization?
Where has Femasys received regulatory approvals for FemBloc?
Why is the New Zealand approval significant for Femasys (FEMY)?
