Femasys Announces Peer-Reviewed Publication of Positive Safety and Efficacy Results from FemBloc® Permanent Birth Control Clinical Trials
Femasys (NASDAQ: FEMY) has announced the publication of positive clinical trial results for FemBloc®, its permanent birth control solution, in the Journal of Gynecology & Reproductive Medicine. The prospective, multi-center trials demonstrated compelling effectiveness and five-year safety data for the in-office therapeutic product.
The trials showed high satisfaction rates among both patients and practitioners, supporting FemBloc's potential as a non-surgical alternative to traditional sterilization procedures. The peer-reviewed publication represents a significant milestone in Femasys's mission to provide safer, more accessible permanent contraception options.
Femasys (NASDAQ: FEMY) ha annunciato la pubblicazione di risultati positivi di studi clinici per FemBloc®, la sua soluzione di contraccezione permanente, nel Journal of Gynecology & Reproductive Medicine. Gli studi prospettici, condotti in più centri, hanno dimostrato un'efficacia convincente e dati di sicurezza a cinque anni per il prodotto terapeutico in ambulatorio.
Gli studi hanno mostrato alti tassi di soddisfazione sia tra i pazienti che tra i professionisti, supportando il potenziale di FemBloc come alternativa non chirurgica alle procedure di sterilizzazione tradizionali. La pubblicazione sottoposta a revisione paritaria rappresenta una tappa significativa nella missione di Femasys di fornire opzioni di contraccezione permanente più sicure e accessibili.
Femasys (NASDAQ: FEMY) ha anunciado la publicación de resultados positivos de ensayos clínicos para FemBloc®, su solución de control de natalidad permanente, en el Journal of Gynecology & Reproductive Medicine. Los ensayos prospectivos, realizados en múltiples centros, demostraron una efectividad convincente y datos de seguridad a cinco años para el producto terapéutico en consultorio.
Los ensayos mostraron altos índices de satisfacción tanto entre los pacientes como entre los profesionales, apoyando el potencial de FemBloc como una alternativa no quirúrgica a los procedimientos de esterilización tradicionales. La publicación revisada por pares representa un hito significativo en la misión de Femasys de proporcionar opciones de anticoncepción permanente más seguras y accesibles.
Femasys (NASDAQ: FEMY)는 FemBloc®의 긍정적인 임상 시험 결과를 산부인과 및 생식 의학 저널에 발표했다고 밝혔습니다. 다기관의 전향적 시험은 사무실 내 치료 제품에 대한 설득력 있는 효과와 5년 안전성 데이터를 입증했습니다.
시험 결과는 환자와 전문가 모두에서 높은 만족도를 보여주었으며, FemBloc이 전통적인 불임 수술 절차에 대한 비수술적 대안으로서의 가능성을 뒷받침합니다. 동료 검토를 거친 이 출판물은 Femasys의 안전하고 접근 가능한 영구 피임 옵션을 제공하려는 사명에서 중요한 이정표를 나타냅니다.
Femasys (NASDAQ: FEMY) a annoncé la publication de résultats positifs d'essais cliniques pour FemBloc®, sa solution de contraception permanente, dans le Journal of Gynecology & Reproductive Medicine. Les essais prospectifs, menés dans plusieurs centres, ont démontré une efficacité convaincante et des données de sécurité sur cinq ans pour le produit thérapeutique en cabinet.
Les essais ont montré des taux de satisfaction élevés tant chez les patients que chez les praticiens, soutenant le potentiel de FemBloc en tant qu'alternative non chirurgicale aux procédures de stérilisation traditionnelles. La publication évaluée par des pairs représente une étape importante dans la mission de Femasys de fournir des options de contraception permanente plus sûres et accessibles.
Femasys (NASDAQ: FEMY) hat die Veröffentlichung positiver klinischer Studienergebnisse für FemBloc®, seine permanente Verhütungslösung, im Journal of Gynecology & Reproductive Medicine angekündigt. Die prospektiven, multizentrischen Studien zeigten überzeugende Wirksamkeit und Sicherheitsdaten über fünf Jahre für das therapeutische Produkt in der Praxis.
Die Studien ergaben hohe Zufriedenheitsraten sowohl bei Patienten als auch bei Fachleuten und unterstützen das Potenzial von FemBloc als nicht-chirurgische Alternative zu traditionellen Sterilisationsverfahren. Die peer-reviewed Veröffentlichung stellt einen bedeutenden Meilenstein in der Mission von Femasys dar, sicherere und zugänglichere permanente Verhütungsoptionen anzubieten.
- Successful peer-reviewed publication of clinical trial results
- Positive 5-year safety data
- High satisfaction rates from patients and practitioners
- Demonstrated effectiveness in permanent birth control
- None.
Insights
Femasys' announcement of peer-reviewed positive clinical trial results for FemBloc represents a significant milestone in the company's development pipeline, potentially strengthening its position in the $10+ billion global contraceptive market.
The publication validates FemBloc's safety and efficacy profile over a five-year period, addressing a critical gap in the permanent birth control landscape following Bayer's withdrawal of Essure in 2018 due to safety concerns. FemBloc's in-office, non-surgical approach could capture significant market share if it maintains the reported safety profile through regulatory approval.
For investors, this development carries several important implications:
- Regulatory pathway advancement: While peer-reviewed publication is a positive step, Femasys must still complete its pivotal FINALE trial before FDA submission. The company initiated this trial in late 2023, suggesting a potential approval timeline of 2026-2027 at the earliest.
- Financial considerations: With a market cap of just
$36 million and a relatively low cash burn rate (approximately$3-4 million per quarter), Femasys will likely need additional capital to complete clinical development and prepare for commercialization. - Portfolio synergy: FemBloc complements Femasys' diagnostic products like FemVue and FemCerv, potentially creating a comprehensive women's health platform that could enhance commercial adoption.
The permanent birth control market represents a substantial opportunity, with approximately 600,000 tubal ligation procedures performed annually in the US alone. A non-surgical alternative could expand this market significantly by attracting women deterred by surgery's invasiveness and recovery time.
Despite these positives, investors should recognize that clinical validation doesn't guarantee commercial success. The path to market still involves regulatory hurdles, physician adoption challenges, and reimbursement considerations. Additionally, the contraceptive landscape includes numerous temporary options that compete indirectly with permanent solutions.
This publication marks important progress, but Femasys remains a speculative investment until FemBloc advances further through regulatory channels and demonstrates commercial viability.
--Positive data from prospective, multi-center trials confirmed compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners--
ATLANTA, Feb. 25, 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 peer-reviewed publication of positive data from its initial clinical trials of FemBloc® permanent birth control in the Journal of Gynecology & Reproductive Medicine (JGRM), a leading peer-reviewed journal covering gynecology and reproductive medicine.
“This peer-reviewed publication detailing positive prospective, multi-center clinical trial data for FemBloc brings Femasys closer to achieving our goal of providing a safer, more accessible in-office alternative to longstanding surgical sterilization for permanent contraception, without compromising effectiveness,” stated Kathy Lee-Sepsick, CEO of Femasys. “The investigators who participated in these clinical trials share a commitment to advancing women’s health by expanding contraceptive options with FemBloc, a much-needed advancement in permanent birth control.”
About the Data1
The publication entitled, “FemBloc Non-Surgical Permanent Contraception for Occlusion of the Fallopian Tubes” includes positive data from three initial clinical trials (Clinicaltrials.gov NCT03067272, NCT03433911, and NCT04273594). The pregnancy rate for FemBloc subjects, who met trial eligibility and were determined bilaterally occluded after a confirmation test three months post-FemBloc was
About FemBloc
FemBloc® permanent birth control is a revolutionary first-of-its-kind non-surgical approach, that involves minimally-invasive delivery of a proprietary synthetic tissue adhesive to occlude the fallopian tubes, fully degrading and producing nonfunctional scar tissue, offering a safe and effective option to reduce the risk of unintended pregnancy. In contrast to historic surgical sterilization, the FemBloc approach offers a non-surgical, more accessible in-office alternative with fewer risks, contraindications, and substantially lower cost. Participants are being enrolled in the FINALE pivotal clinical trial (NCT05977751) for U.S. approval. Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.1 Learn more at www.FemBloc.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. Peer-reviewed publication of positive data from its initial clinical trials of FemBloc have demonstrated compelling effectiveness and five-year safety with high satisfaction from both patients and practitioners.1 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
1Liu, 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.
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 are the key findings from FemBloc's clinical trials by Femasys (FEMY)?
How does FemBloc differ from traditional permanent birth control methods?
Where were the FemBloc clinical trial results published?
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