Femasys Announces UK Regulatory Approvals for FemaSeed® for Female Infertility Treatment and Two Diagnostic Devices
Femasys Inc. (NASDAQ: FEMY) has received regulatory approvals from the UK's Medicines & Healthcare products Regulatory Agency (MHRA) for three products: FemaSeed®, an intratubal insemination product for female infertility treatment, FemVue® for tubal evaluation, and FemCerv® for cervical cancer detection.
These UK approvals follow previous clearances and approvals in the United States, Europe, Canada, and Israel, marking an important expansion of Femasys' global market presence. The company focuses on providing innovative, accessible in-office therapeutic and diagnostic solutions for women's health needs.
Femasys Inc. (NASDAQ: FEMY) ha ricevuto approvazioni regolatorie dall'Agenzia del Regno Unito per i Medicinali e i Prodotti Sanitari (MHRA) per tre prodotti: FemaSeed®, un prodotto per l'inseminazione intratubo per il trattamento dell'infertilità femminile, FemVue® per la valutazione tubarica, e FemCerv® per la rilevazione del cancro cervicale.
Queste approvazioni nel Regno Unito seguono precedenti autorizzazioni e approvazioni negli Stati Uniti, in Europa, in Canada e in Israele, segnando un'importante espansione della presenza globale di Femasys. L'azienda si concentra sull'offerta di soluzioni terapeutiche e diagnostiche innovative e accessibili per le esigenze di salute delle donne.
Femasys Inc. (NASDAQ: FEMY) ha recibido aprobaciones regulatorias de la Agencia Reguladora de Medicamentos y Productos de Salud del Reino Unido (MHRA) para tres productos: FemaSeed®, un producto de inseminación intratubárica para el tratamiento de la infertilidad femenina, FemVue® para la evaluación tubárica, y FemCerv® para la detección del cáncer cervical.
Estas aprobaciones en el Reino Unido siguen a autorizaciones previas en Estados Unidos, Europa, Canadá e Israel, marcando una importante expansión de la presencia global de Femasys. La empresa se enfoca en proporcionar soluciones terapéuticas y diagnósticas innovadoras y accesibles para las necesidades de salud de las mujeres.
Femasys Inc. (NASDAQ: FEMY)는 영국 의약품 및 건강 관리 제품 규제 기관(MHRA)으로부터 세 가지 제품에 대한 규제 승인을 받았습니다: FemaSeed®, 여성 불임 치료를 위한 자궁내 인공 수정 제품, FemVue®, 난관 평가용, FemCerv®, 자궁경부암 검출용입니다.
이러한 영국 승인에는 미국, 유럽, 캐나다 및 이스라엘에서의 이전 승인도 포함되어 있으며, Femasys의 글로벌 시장 존재감이 중요한 확장을 이루고 있습니다. 이 회사는 여성의 건강 요구에 대한 혁신적이고 접근 가능한 진료 및 진단 솔루션을 제공하는 데 중점을 두고 있습니다.
Femasys Inc. (NASDAQ: FEMY) a obtenu des approbations réglementaires de l'Agence des médicaments et des produits de santé du Royaume-Uni (MHRA) pour trois produits : FemaSeed®, un produit d'insémination intratubaire pour le traitement de l'infertilité féminine, FemVue® pour l'évaluation tubaire, et FemCerv® pour la détection du cancer du col de l'utérus.
Ces approbations au Royaume-Uni font suite à des autorisations précédentes aux États-Unis, en Europe, au Canada et en Israël, marquant une expansion importante de la présence mondiale de Femasys. L'entreprise se concentre sur l'offre de solutions thérapeutiques et diagnostiques innovantes et accessibles pour les besoins de santé des femmes.
Femasys Inc. (NASDAQ: FEMY) hat von der britischen Arzneimittel- und Gesundheitsbehörde (MHRA) Zulassungen für drei Produkte erhalten: FemaSeed®, ein Produkt zur intratubaren Befruchtung zur Behandlung von weiblicher Unfruchtbarkeit, FemVue® zur Tubenbewertung und FemCerv® zur Erkennung von Gebärmutterhalskrebs.
Diese Genehmigungen im Vereinigten Königreich folgen früheren Zulassungen in den Vereinigten Staaten, Europa, Kanada und Israel und markieren eine wichtige Expansion der globalen Marktpräsenz von Femasys. Das Unternehmen konzentriert sich darauf, innovative und zugängliche therapeutische und diagnostische Lösungen für die Gesundheitsbedürfnisse von Frauen anzubieten.
- Received UK regulatory approval for three products
- Expanded market presence to a new territory
- Products already approved in multiple major markets (US, Europe, Canada, Israel)
- None.
Insights
The MHRA approval represents a significant expansion of Femasys's regulatory footprint, particularly noteworthy as the UK market operates under distinct post-Brexit regulations. The synchronized approval of three products - FemaSeed, FemVue and FemCerv - demonstrates remarkable regulatory execution and validates the company's multi-product strategy.
The UK women's healthcare market presents a substantial opportunity, with approximately 1 in 7 couples experiencing fertility issues and cervical cancer screening programs covering millions of women annually. Having both therapeutic (FemaSeed) and diagnostic (FemVue, FemCerv) products approved creates valuable cross-selling opportunities and positions Femasys as a comprehensive women's health solutions provider.
The company's regulatory success across multiple jurisdictions (US, Europe, Canada, Israel and now UK) suggests robust clinical data and manufacturing standards. This comprehensive geographical coverage significantly enhances the company's commercial potential and could attract partnership opportunities with global healthcare providers. The ability to commercialize multiple products in major markets could accelerate revenue diversification and market penetration strategies.
The UK market entry with a comprehensive product portfolio represents a strategic advantage in the competitive women's healthcare sector. The NHS's structure as a single-payer system could streamline adoption if these products demonstrate cost-effectiveness compared to existing solutions. The FemaSeed system's potential for in-office procedures could align well with the NHS's focus on efficient resource utilization and accessibility.
The combination of fertility treatment and diagnostic capabilities creates a unique market position. This integrated approach could lead to preferential adoption by healthcare providers looking to streamline their women's health services. The timing is particularly advantageous as healthcare systems globally seek more efficient, cost-effective solutions for women's health needs.
From a commercial perspective, having all three products approved simultaneously enables efficient market entry strategies and resource allocation. The company can leverage a single sales force to target multiple departments within healthcare facilities, potentially accelerating market penetration and improving sales efficiency.
UK regulatory approval follows FemaSeed, FemVue and FemCerv clearance/ approvals in the U.S., Europe, Canada and Israel
ATLANTA, Feb. 11, 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 receipt of the Medicines & Healthcare products Regulatory Agency (MHRA) approvals for the FemaSeed® Intratubal Insemination product for female infertility treatment and two diagnostic devices, FemVue® for tubal evaluation and FemCerv® for cervical cancer detection.
“This is another key milestone as we expand our reach to the UK following successful approval across Europe for our innovative infertility and cancer detection products.” stated Kathy Lee-Sepsick, Femasys’ CEO. “We remain committed to advancing much-needed options that are safe, effective and cutting-edge for patients globally.”
About FemaSeed
FemaSeed® is an innovative advancement in artificial insemination, designed to enhance fertilization by precisely delivering sperm into the fallopian tube, the natural site of conception. It offers a safe, accessible and cost-effective first-line therapeutic option for infertile women, men and couples seeking pregnancy through insemination. FemaSeed offers a revolutionary alternative to IUI, enabling healthcare professionals to expand their practice services with a more effective approach as demonstrated in the pivotal trial (NCT0468847) for low male sperm count.1 It serves as an affordable, less burdensome and lower-risk first step before IVF. Learn more at www.femaseed.com.
About FemVue
FemVue® is the first FDA-cleared product that creates natural saline and air contrast for a safe, reliable, real-time evaluation of the fallopian tubes using ultrasound. When combined with a uterine cavity assessment, it provides a comprehensive exam in the comfort of the gynecologist’s office. Since FemaSeed infertility treatment requires at least one open fallopian tube, FemVue is an essential companion diagnostic. Learn more at www.femvue.com.
About FemCerv
FemCerv® is the first and only FDA-cleared product purposefully designed to collect a comprehensive and uncontaminated sample in a pain-free office procedure for the detection of cervical cancer. Learn more at www.femcerv.com.
About Femasys
Femasys, an Atlanta-based leading biomedical innovator, develops and commercializes a portfolio of patent-protected, minimally invasive women’s health solutions, all manufactured in the U.S. Our innovative therapeutic and diagnostic products have received global regulatory approvals and are being commercialized in the U.S. and select countries. FemaSeed® Intratubal Insemination, a groundbreaking infertility treatment delivering sperm directly to the site of conception, is U.S. FDA-cleared and approved in Europe, UK, Canada and Israel. FemVue®, a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared with approvals in Europe, UK, Canada, Japan and Israel. FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared with approvals in Europe, UK, Canada and Israel. FemBloc® permanent birth control, the Company’s late-stage product candidate, is the first and only non-surgical, in-office, method offering significant benefits over the costly, inconvenient, risk-laden surgical alternative. The pivotal clinical trial (NCT05977751) is now enrolling participants for U.S. approval. FemCath® and FemChec®, companion diagnostic products for FemBloc’s ultrasound-based confirmation test, are U.S. FDA-cleared and approved in Europe and Canada. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
Reference
1 Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, K. Lee-Sepsick (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.
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 develop and advance our current product candidates and programs into, and successfully initiate, enroll and complete, clinical trials; the ability of our clinical trials to demonstrate safety and effectiveness of our product candidates and other positive results; estimates regarding the total addressable market for our products and product candidates; our ability to commercialize our products and product candidates, 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, 2023, 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 products did Femasys (FEMY) receive UK approval for in February 2025?
In which countries are Femasys (FEMY) products currently approved?
What is the purpose of Femasys' FemaSeed product?