Femasys Achieves Australian and New Zealand Regulatory Approvals for FemaSeed® for First-Line Infertility Treatment and FemVue Diagnostic
Femasys (NASDAQ:FEMY) has secured regulatory approvals in Australia and New Zealand for two key products in its women's health portfolio. The approvals cover FemaSeed®, a first-line intratubal insemination treatment for infertility, and FemVue®, a diagnostic evaluation tool.
According to CEO Kathy Lee-Sepsick, these regulatory milestones represent significant progress in expanding global access to the company's innovative infertility solutions. The approvals are expected to create new commercial opportunities and support revenue growth while expanding Femasys's global market presence.
Femasys (NASDAQ:FEMY) ha ottenuto le approvazioni regolatorie in Australia e Nuova Zelanda per due prodotti chiave del suo portafoglio dedicato alla salute femminile. Le approvazioni riguardano FemaSeed®, un trattamento di prima linea per l'inseminazione intratubale contro l'infertilità, e FemVue®, uno strumento diagnostico di valutazione.
Secondo la CEO Kathy Lee-Sepsick, questi traguardi regolatori rappresentano un progresso significativo nell'ampliare l'accesso globale alle soluzioni innovative dell'azienda per l'infertilità. Le approvazioni dovrebbero generare nuove opportunità commerciali e sostenere la crescita dei ricavi, ampliando al contempo la presenza globale di Femasys sul mercato.
Femasys (NASDAQ:FEMY) ha obtenido aprobaciones regulatorias en Australia y Nueva Zelanda para dos productos clave de su portafolio de salud femenina. Las aprobaciones cubren FemaSeed®, un tratamiento de primera línea para inseminación intratubárica contra la infertilidad, y FemVue®, una herramienta de evaluación diagnóstica.
Según la CEO Kathy Lee-Sepsick, estos hitos regulatorios representan un avance significativo para ampliar el acceso global a las innovadoras soluciones de infertilidad de la compañía. Se espera que las aprobaciones generen nuevas oportunidades comerciales y apoyen el crecimiento de ingresos, al mismo tiempo que expanden la presencia global de Femasys en el mercado.
Femasys (NASDAQ:FEMY)는 호주와 뉴질랜드에서 여성 건강 포트폴리오의 핵심 제품 두 가지에 대한 규제 승인을 획득했습니다. 승인 대상은 불임 치료를 위한 1차 내관내 인공수정 치료제인 FemaSeed®와 진단 평가 도구인 FemVue®입니다.
CEO 캐시 리-셉식에 따르면, 이번 규제 승인 성과는 회사의 혁신적인 불임 솔루션에 대한 글로벌 접근성을 확대하는 데 있어 중요한 진전을 의미합니다. 이 승인들은 새로운 상업적 기회를 창출하고 매출 성장을 지원하는 동시에 Femasys의 글로벌 시장 입지를 확장할 것으로 기대됩니다.
Femasys (NASDAQ:FEMY) a obtenu les approbations réglementaires en Australie et en Nouvelle-Zélande pour deux produits clés de son portefeuille santé féminine. Les autorisations concernent FemaSeed®, un traitement de première intention par insémination intratubaire contre l'infertilité, et FemVue®, un outil d'évaluation diagnostique.
Selon la PDG Kathy Lee-Sepsick, ces étapes réglementaires représentent des progrès importants pour élargir l'accès mondial aux solutions innovantes de l'entreprise en matière d'infertilité. Ces approbations devraient créer de nouvelles opportunités commerciales et soutenir la croissance des revenus tout en renforçant la présence mondiale de Femasys sur le marché.
Femasys (NASDAQ:FEMY) hat in Australien und Neuseeland behördliche Zulassungen für zwei wichtige Produkte seines Portfolios im Bereich Frauengesundheit erhalten. Die Zulassungen betreffen FemaSeed®, eine Erstlinienbehandlung für intratubare Insemination bei Unfruchtbarkeit, sowie FemVue®, ein diagnostisches Bewertungsinstrument.
Nach Angaben der CEO Kathy Lee-Sepsick stellen diese behördlichen Meilensteine einen bedeutenden Fortschritt dar, um den globalen Zugang zu den innovativen Unfruchtbarkeitslösungen des Unternehmens zu erweitern. Die Zulassungen sollen neue Geschäftsmöglichkeiten schaffen und das Umsatzwachstum unterstützen sowie die globale Marktpräsenz von Femasys ausbauen.
- Regulatory approvals secured in both Australia and New Zealand markets
- Expansion of global market presence for two key products
- New commercial opportunities in significant markets
- Validation of clinical value for company's platform
- None.
-- Milestone expands global reach and reinforces commitment to accessible, first-line infertility solutions --
ATLANTA, July 01, 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 the achievement of regulatory approvals in Australia and New Zealand for its next-generation infertility solutions: FemaSeed® for first-line intratubal insemination treatment and FemVue® for diagnostic evaluation.
“Securing regulatory approvals in Australia and New Zealand mark another important step in expanding global access to our innovative infertility solutions,” said Kathy Lee-Sepsick, CEO and Founder of Femasys. “With FemaSeed and FemVue, we are delivering much-needed, first-line options that address critical gaps in care for women struggling with infertility. These milestones not only validate the clinical value of our platform but also create meaningful commercial opportunities as we continue to grow revenue and broaden our global footprint.”
About FemaSeed
FemaSeed® is a next-generation artificial insemination solution that enhances fertilization by precisely delivering sperm to the fallopian tube, the natural site of conception. Offering a safe, accessible, and cost-effective first-line treatment, FemaSeed provides a more effective alternative to intrauterine insemination (IUI). In the pivotal clinical trial (NCT0468847), it achieved over double the pregnancy rates of IUI in cases of low male sperm count.1 FemaSeed is an affordable, less invasive, lower-risk option before IVF. It is authorized for use in the U.S., Europe, UK, Canada, Israel, Australia and New Zealand. Learn more at www.femaseed.com.
About FemVue
FemVue® is a transformative, ultrasound-based alternative to radiologic imaging procedures for evaluating fallopian tube patency. It creates natural saline and air contrast for a safe, reliable, real-time assessment, all within the comfort of the gynecologist’s office. When combined with a uterine cavity evaluation, it offers a comprehensive fertility exam. Because FemaSeed® requires at least one open fallopian tube, FemVue serves as an essential companion diagnostic to guide appropriate patient selection. It is authorized for use in the U.S., Japan, Europe, UK, Canada, Israel, Australia and New Zealand. Learn more at www.femvue.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
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