Femasys announces positive trial results for FemBloc® permanent birth control, demonstrating effectiveness, safety, and high satisfaction rates.
Quiver AI Summary
Femasys Inc. announced the publication of positive results from clinical trials for its FemBloc® permanent birth control product in the Journal of Gynecology & Reproductive Medicine. These trials demonstrated FemBloc's effectiveness, achieving a pregnancy rate of 0% among eligible participants, and showed ongoing safety with no serious adverse events reported over five years. The non-surgical method aims to provide a safer and more accessible in-office alternative to traditional surgical sterilization methods. Both patients and practitioners reported high satisfaction with FemBloc. The company is currently enrolling participants in a pivotal trial for U.S. approval as it continues to innovate in women's health solutions.
Potential Positives
- Publication of positive data in a leading peer-reviewed journal enhances credibility and visibility for FemBloc, attracting interest from the medical community.
- The reported pregnancy rate of 0% among trial participants exceeds the historical performance goal of 6% for surgical sterilization, showcasing the effectiveness of FemBloc.
- High levels of satisfaction reported from both patients and practitioners indicate strong market acceptance and potential for widespread adoption of FemBloc.
- The ongoing pivotal clinical trial for U.S. approval suggests progress towards commercial availability, positioning Femasys for future growth in the women's health market.
Potential Negatives
- The press release includes extensive forward-looking statements, indicating potential uncertainties and risks which could impact the company's future performance and product commercialization.
- Although the press release highlights positive outcomes from initial clinical trials, it also underscores the fact that the clinical trials for FemBloc are still ongoing, implying that final regulatory approval and market introduction are not guaranteed.
- The reliance on a single product, FemBloc, for addressing significant unmet needs in women's health may raise concerns about the company's overall resilience and ability to diversify its product portfolio against market fluctuations.
FAQ
What are the key findings of the FemBloc clinical trials?
The clinical trials show a 0% pregnancy rate and high satisfaction from patients and practitioners, confirming FemBloc's effectiveness and safety.
How does FemBloc compare to traditional surgical sterilization?
FemBloc is a non-surgical, in-office method that offers easier access, lower costs, and fewer risks than traditional surgical sterilization.
Where can I find the publication of the FemBloc trial data?
The positive trial data for FemBloc is published in the Journal of Gynecology & Reproductive Medicine.
What is the FINALE pivotal clinical trial?
The FINALE trial is currently enrolling participants for U.S. approval of FemBloc, evaluating its safety and effectiveness further.
Who is the CEO of Femasys and what is their vision for FemBloc?
Kathy Lee-Sepsick is the CEO of Femasys, aiming to provide safer, accessible contraception options with FemBloc.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
--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 Data
1
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 0% (95%UCB: 0.057; n=0/51). This is significantly lower than the performance goal of 6% based on the historical control, surgical sterilization (one-sided p-value=0.0426). Safety reports were consistent with those typically observed for intrauterine transcervical procedures, with no on-going safety concerns through five years. There were no reports of serious adverse events (n=0/229). The vast majority of subjects stated they would probably or definitely recommend FemBloc, and investigator satisfaction was similarly high.
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
1
Liu, 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
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