--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 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
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.
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