Femasys Announces Israeli Regulatory Approvals for FemaSeed® for Female Infertility Treatment and Two Diagnostic Devices
Femasys Inc. (FEMY) has received regulatory approvals from Israel's Medical Device Division (AMAR) for three products: FemaSeed®, an intratubal insemination product for female infertility treatment, along with two diagnostic devices - FemVue® for tubal evaluation and FemCerv® for cervical cancer detection.
This approval follows FemaSeed's previous regulatory milestones, including FDA clearance in September 2023 and EU CE mark approval in June 2024. The company aims to provide accessible, lower-cost options for women's healthcare through in-office therapeutic and diagnostic products. Femasys is focusing on commercial execution in the U.S. and select markets as it continues expanding its product availability globally.
Femasys Inc. (FEMY) ha ricevuto approvazioni regolatorie dalla Divisione Dispositivi Medici di Israele (AMAR) per tre prodotti: FemaSeed®, un prodotto di inseminazione intratubale per il trattamento dell'infertilità femminile, insieme a due dispositivi diagnostici - FemVue® per la valutazione tubarica e FemCerv® per la rilevazione del cancro cervicale.
Questa approvazione segue le precedenti tappe regolatorie di FemaSeed, tra cui l'autorizzazione della FDA a settembre 2023 e l'approvazione del marchio CE dell'UE a giugno 2024. L'azienda ha l'obiettivo di fornire opzioni accessibili e a basso costo per la salute delle donne attraverso prodotti terapeutici e diagnostici in ambulatorio. Femasys si sta concentrando sull'esecuzione commerciale negli Stati Uniti e in mercati selezionati mentre continua a espandere la disponibilità dei suoi prodotti a livello globale.
Femasys Inc. (FEMY) ha recibido aprobaciones regulatorias de la División de Dispositivos Médicos de Israel (AMAR) para tres productos: FemaSeed®, un producto de inseminación intratubaria para el tratamiento de la infertilidad femenina, junto con dos dispositivos diagnósticos - FemVue® para la evaluación tubárica y FemCerv® para la detección del cáncer de cuello uterino.
Esta aprobación sigue los hitos regulatorios anteriores de FemaSeed, incluyendo la autorización de la FDA en septiembre de 2023 y la aprobación del marcado CE de la UE en junio de 2024. La empresa tiene como objetivo proporcionar opciones accesibles y de bajo costo para la atención de la salud de las mujeres a través de productos terapéuticos y diagnósticos en consultorios. Femasys se centra en la ejecución comercial en EE. UU. y en mercados selectos mientras continúa expandiendo la disponibilidad de sus productos a nivel mundial.
Femasys Inc. (FEMY)는 이스라엘 의료기기 부서(AMAR)로부터 세 가지 제품에 대한 규제 승인을 받았습니다: FemaSeed®, 여성 불임 치료를 위한 자궁관 내 인공수정 제품이며, 두 개의 진단기기 - FemVue® 자궁관 평가용 및 FemCerv® 자궁경부암 검출용입니다.
이 승인은 FemaSeed의 FDA 승인(2023년 9월) 및 유럽연합 CE 마크 승인(2024년 6월) 등 이전 규제 이정표에 이어 이루어진 것입니다. 회사는 진료실에서 사용할 수 있는 저렴한 옵션을 통해 여성 건강 관리를 접근 가능하게 제공하는 것을 목표로 하고 있습니다. Femasys는 미국 및 선정된 시장에서 상업적 실행에 집중하고 있으며, 글로벌 제품 가용성 확대를 지속하고 있습니다.
Femasys Inc. (FEMY) a reçu des approbations réglementaires de la Division des Dispositifs Médicaux d'Israël (AMAR) pour trois produits : FemaSeed®, un produit d'insémination intratubaire pour le traitement de l'infertilité féminine, ainsi que deux dispositifs de diagnostic - FemVue® pour l'évaluation tubaire et FemCerv® pour la détection du cancer du col de l'utérus.
Cette approbation fait suite aux précédentes étapes réglementaires de FemaSeed, y compris l'autorisation de la FDA en septembre 2023 et l'approbation du marquage CE de l'UE en juin 2024. L'entreprise vise à fournir des options abordables et accessibles pour les soins de santé des femmes grâce à des produits thérapeutiques et diagnostiques en milieu clinique. Femasys se concentre sur l'exécution commerciale aux États-Unis et sur certains marchés tout en continuant d'élargir la disponibilité de ses produits à l'échelle mondiale.
Femasys Inc. (FEMY) hat von der Medizinprodukteabteilung Israels (AMAR) regulatorische Genehmigungen für drei Produkte erhalten: FemaSeed®, ein intratubares Inseminationsprodukt zur Behandlung der weiblichen Unfruchtbarkeit, sowie zwei Diagnosetechnologien - FemVue® zur Untersuchung der Eileiter und FemCerv® zur Erkennung von Gebärmutterhalskrebs.
Diese Genehmigung folgt den vorherigen regulatorischen Meilensteinen von FemaSeed, einschließlich der FDA-Zulassung im September 2023 und der CE-Kennzeichnung der EU im Juni 2024. Das Unternehmen zielt darauf ab, zugängliche, kostengünstige Optionen für die Gesundheitsversorgung von Frauen durch therapeutische und diagnostische Produkte in Arztpraxen bereitzustellen. Femasys konzentriert sich auf die kommerzielle Umsetzung in den USA und in ausgewählten Märkten, während es weiterhin die Verfügbarkeit seiner Produkte weltweit ausweitet.
- Received Israeli regulatory approval for three products (FemaSeed, FemVue, and FemCerv)
- Expands global market presence following US FDA and EU approvals
- Strengthens commercial footprint in international markets
- None.
Insights
The Israeli regulatory approval marks a significant milestone in Femasys's global commercialization strategy, particularly noteworthy given Israel's reputation as a hub for medical innovation and early adoption of new healthcare technologies. The approval encompasses their complete suite of women's health products, creating a comprehensive market entry strategy.
The timing is strategically important as it follows FDA clearance in September 2023 and CE mark approval in June 2024, establishing a strong regulatory foundation across major markets. Israel's healthcare system, known for its advanced medical infrastructure and high adoption rates of innovative technologies, could serve as an important reference market for further expansion in the Middle East region.
For a company with a market cap of
The comprehensive approval of all three devices - spanning infertility treatment, diagnostic imaging and cancer detection - positions Femasys to maximize operational efficiency in their commercialization efforts. This integrated approach could lead to better market penetration and potentially lower per-market entry costs compared to sequential product launches.
Regulatory approval follows FemaSeed U.S. FDA-clearance announced September 2023 and EU CE mark approval announced June 2024
ATLANTA, Feb. 04, 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 Israeli Medical Device Division of the Ministry of Health’s (AMAR) 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.
“We remain committed to our mission of delivering critically important technological advancements to women globally, with Israel now added to our expanding reach.” stated Kathy Lee-Sepsick, Femasys’ CEO. “FemaSeed, along with our entire suite of products, has been developed to provide women with better, lower-cost and more accessible options. We remain focused on commercial execution in the U.S. and select other countries as we continue to expand the availability of our much-needed product solutions.”
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, Canada and Israel. FemVue®, a companion diagnostic for fallopian tube assessment via ultrasound, is U.S. FDA-cleared with approvals in Europe, Canada, Japan and Israel. FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis, is U.S. FDA-cleared with approvals in Europe, 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:
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FAQ
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