Femasys Inc. Receives U.S. FDA Clearance to Market FemChec®, an Innovative Diagnostic Solution for Fallopian Tube Check
Femasys Inc. (Nasdaq: FEMY) has received 510(k) clearance from the FDA for FemChec®, an innovative diagnostic solution for checking fallopian tubes. FemChec is designed for controlled delivery of contrast to confirm tubal status. It is a important component of Femasys' FemBloc® non-surgical permanent birth control solution, currently in late-stage pivotal trials. FemChec allows for procedure success confirmation by the same practitioner using natural contrast and ultrasound, eliminating the need for radiology referrals and radiation exposure. This clearance strengthens Femasys' position in providing safe and advanced diagnostic and therapeutic solutions for women's healthcare needs.
Femasys Inc. (Nasdaq: FEMY) ha ricevuto l'autorizzazione 510(k) dalla FDA per FemChec®, una soluzione diagnostica innovativa per il controllo delle tube di Falloppio. FemChec è progettato per una somministrazione controllata del contrasto per confermare lo stato tubarico. È un componente importante della soluzione di contraccezione permanente non chirurgica FemBloc® di Femasys, attualmente in fase di sperimentazione clinica avanzata. FemChec consente di confermare il successo della procedura dallo stesso professionista utilizzando contrasto naturale e ultrasuoni, eliminando la necessità di rinvii a radiologia e l'esposizione a radiazioni. Questa autorizzazione rafforza la posizione di Femasys nell'offrire soluzioni diagnostiche e terapeutiche sicure e avanzate per le esigenze sanitarie delle donne.
Femasys Inc. (Nasdaq: FEMY) ha recibido la autorización 510(k) de la FDA para FemChec®, una solución diagnóstica innovadora para comprobar las trompas de Falopio. FemChec está diseñado para la administración controlada de contraste para confirmar el estado tubárico. Es un componente importante de la solución de control de natalidad permanente no quirúrgico FemBloc® de Femasys, actualmente en ensayos clínicos avanzados. FemChec permite la confirmación del éxito del procedimiento por el mismo profesional utilizando contraste natural y ecografía, eliminando la necesidad de referencias a radiología y la exposición a radiaciones. Esta autorización refuerza la posición de Femasys en la provisión de soluciones diagnósticas y terapéuticas seguras y avanzadas para las necesidades de salud de las mujeres.
Femasys Inc. (Nasdaq: FEMY)는 FemChec®에 대해 FDA로부터 510(k) 허가를 받았습니다. FemChec는 난관의 상태를 확인하기 위해 조절된 방식으로 조영제를 전달하는 혁신적인 진단 솔루션입니다. 이는 현재 후기 단계의 중요 임상 시험 중인 Femasys의 비수술적 영구 생식 통제 FemBloc® 솔루션의 중요한 구성 요소입니다. FemChec는 자연 조영제와 초음파를 사용하여 동일한 전문가가 절차의 성공을 확인할 수 있게 하여 방사선학 의뢰 및 방사선 노출의 필요성을 없앱니다. 이러한 허가는 여성 건강 관리 요구에 대한 안전하고 진보된 진단 및 치료 솔루션을 제공하는 Femasys의 입지를 강화합니다.
Femasys Inc. (Nasdaq: FEMY) a reçu l'autorisation 510(k) de la FDA pour FemChec®, une solution diagnostique innovante pour vérifier les trompes de Fallope. FemChec est conçu pour une administration contrôlée de contraste afin de confirmer l'état tubaire. C'est un élément important de la solution de contraception permanente non chirurgicale FemBloc® de Femasys, actuellement en essais cliniques avancés. FemChec permet à un même praticien de confirmer le succès de la procédure en utilisant du contraste naturel et des échographies, éliminant ainsi le besoin de références en radiologie et l'exposition aux radiations. Cette autorisation renforce la position de Femasys dans la fourniture de solutions diagnostiques et thérapeutiques sûres et avancées pour les besoins en santé des femmes.
Femasys Inc. (Nasdaq: FEMY) hat von der FDA die 510(k) Zulassung für FemChec® erhalten, eine innovative diagnostische Lösung zur Überprüfung der Eileiter. FemChec ist für die kontrollierte Abgabe von Kontrastmittel konzipiert, um den Tubenstatus zu bestätigen. Es ist ein wichtiger Bestandteil der nicht-chirurgischen permanenten Empfängnisverhütungsstrategien FemBloc® von Femasys, die sich derzeit in späten klinischen Prüfungen befinden. FemChec ermöglicht es demselben Facharzt, den Erfolg des Verfahrens mit natürlichem Kontrastmittel und Ultraschall zu bestätigen, wodurch die Notwendigkeit von Radiologieüberweisungen und Strahlenexposition entfällt. Diese Zulassung stärkt die Position von Femasys bei der Bereitstellung sicherer und fortschrittlicher diagnostischer sowie therapeutischer Lösungen für die Gesundheitsbedürfnisse von Frauen.
- Received FDA 510(k) clearance for FemChec®, expanding product portfolio
- FemChec is integral to FemBloc® non-surgical permanent birth control solution
- Eliminates need for radiology referrals and radiation exposure in tubal status confirmation
- Strengthens company's position in women's healthcare solutions market
- FemBloc® permanent birth control solution still in pivotal trial phase, not yet approved
Insights
The FDA's 510(k) clearance for FemChec is a significant regulatory milestone for Femasys. This approval demonstrates that the device has met the FDA's safety and efficacy standards, paving the way for market entry. The clearance is particularly noteworthy as FemChec is an integral part of Femasys' broader strategy, complementing their FemBloc permanent birth control solution currently in late-stage trials. This synergy could potentially streamline the regulatory pathway for FemBloc, as FemChec's approval may provide supporting evidence for the overall system's safety and effectiveness. However, investors should note that while this clearance is promising, the success of FemBloc in its pivotal trial remains important for the company's long-term prospects.
FemChec represents a notable advancement in women's reproductive health diagnostics. Its ability to use natural contrast and ultrasound for fallopian tube assessment offers a safer, more accessible alternative to traditional x-ray methods. This approach eliminates radiation exposure and the need for referrals to radiology, potentially increasing patient comfort and reducing healthcare system burden. Moreover, by enabling in-office procedures, FemChec could improve access to reproductive health services, particularly in underserved areas. The integration with FemBloc for non-surgical permanent birth control also positions Femasys to offer a comprehensive solution in contraception, potentially capturing a larger market share in women's health.
The FDA clearance for FemChec is a positive catalyst for Femasys (NASDAQ: FEMY). This approval expands their product portfolio and could lead to near-term revenue generation. However, the full financial impact will likely depend on the success of FemBloc, which is still in clinical trials. Investors should consider that while this news strengthens Femasys' market position, the company's valuation will be significantly influenced by the outcomes of the FINALE pivotal trial for FemBloc. The synergy between FemChec and FemBloc could create a competitive advantage in the women's health market, potentially leading to increased market share and revenue growth if both products are successfully commercialized. Nonetheless, careful monitoring of the ongoing clinical trial results and future commercialization strategies will be important for assessing long-term value.
In addition to 510(k) clearance, FemChec, a contrast generating product, is an integral part of the confirmation test following administration of FemBloc non-surgical permanent birth control, currently in late-stage pivotal trial
ATLANTA, Sept. 09, 2024 (GLOBE NEWSWIRE) -- Femasys, Inc., (Nasdaq: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, today announced it has received 510(k) clearance from the United States Food and Drug Administration (FDA) for FemChec®, an innovative diagnostic solution for checking the fallopian tubes, designed for controlled delivery of contrast for confirmation of tubal status.
Kathy-Lee Sepsick, Femasys Founder and CEO commented, “FemChec is an essential part of our suite of women’s health products, as it fortifies our position to provide safe and technologically-advanced diagnostic and therapeutic solutions addressing women’s healthcare needs. In particular, FemChec is a key element of our FemBloc® non-surgical permanent birth control solution as it allows for confirmation of procedure success by the same practitioner using natural contrast and ultrasound. This is opposed to the traditional methodology, which requires a referral to radiology, utilizes x-ray dye, and unnecessarily exposes the woman to radiation. We look forward to continuing to work with FDA as we progress our FemBloc solution through the FINALE pivotal trial, which is currently enrolling.”
About FemChec®
FemChec is an innovative diagnostic solution designed to instill through controlled delivery, a consistent alternating pattern of saline and air in a continuous stream of contrast media. When used with an intrauterine catheter, it is intended for the controlled delivery of natural contrast during an ultrasound evaluation of the fallopian tubes with or without the uterine cavity. Femasys is supporting an ongoing pivotal clinical trial for our FemBloc non-surgical permanent birth control of which FemChec is part of the confirmation test utilized to confirm success. FemChec has achieved U.S. FDA clearance and regulatory approval in Canada.
About Femasys
Femasys is a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic solutions, including a lead revolutionary product candidate and FDA-cleared products. FemaSeed® Intratubal Insemination, an innovative infertility treatment designed to deliver sperm directly where conception occurs, is FDA-cleared and has received regulatory approval in Canada and Europe. FemBloc® permanent birth control in late-stage clinical development is the first and only non-surgical, in-office, permanent birth control method intended to be a safer option for women at substantially less cost than the long-standing surgical alternative. The Company has developed diagnostic products that are complementary for which it has achieved regulatory approvals to market in the U.S., Canada, Europe, and other ex-U.S. territories, and which are commercial-ready due to its in-house manufacturing capabilities. Its diagnostic products include FemVue® and FemVue® Mini for fallopian tube assessment by ultrasound, which can be used in conjunction with FemCath®, an intrauterine catheter for selective fallopian tube evaluation, and FemCerv®, an endocervical tissue sampler for cervical cancer diagnosis. Learn more at www.femasys.com, or follow us on X, Facebook and LinkedIn.
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, 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:
CORE IR
Matt Blazei
IR@femasys.com
Media:
CORE IR
Kati Waldenburg
Media@femasys.com
FAQ
What is FemChec® and what FDA clearance did it receive?
How does FemChec® relate to Femasys' FemBloc® birth control solution?
What advantages does FemChec® offer over traditional fallopian tube checking methods?
What is the current status of Femasys' FemBloc® permanent birth control solution?
