Femasys Advances FemBloc Toward U.S. Approval with Initiation of Pivotal Trial Enrollment

-- Enrollment begins in the FDA-authorized FINALE pivotal trial evaluating FemBloc, a first-of-its-kind non-surgical permanent birth control, following positive clinical data --

ATLANTA, March 10, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide, announced today the initiation of patient enrollment in the FINALE pivotal clinical trial evaluating FemBloc. This milestone follows U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to advance the study based on positive clinical data generated in its earlier phase. FemBloc has already received regulatory approvals and is being commercialized in Europe and other select countries outside the United States as a non-surgical alternative to the surgical procedures currently used for permanent birth control. Completion of the FINALE study is expected to support a future U.S. regulatory submission.

“Initiating patient enrollment in the final phase of the FINALE trial marks an important milestone toward unlocking the U.S. market for FemBloc and reflects our continued commitment to advancing women’s healthcare,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “Following years of development, clinical validation, and regulatory progress, including approvals outside the United States, this pivotal trial represents the final step in executing our U.S. strategy and advancing long-term value creation for Femasys stakeholders.”

“Having been involved in the FemBloc clinical program from its early studies through this pivotal phase, I am pleased to see the FINALE trial advance to its final stage,” said Dr. Scott Chudnoff, Principal Investigator of the FINALE trial, Chair of Obstetrics & Gynecology at Maimonides Medical Center. “A non-surgical approach has the potential to expand access while reducing the risks associated with surgery, addressing a longstanding unmet need for women in the U.S.”

Permanent birth control is one of the most widely used contraceptive methods worldwide, yet current options require surgery, anesthesia, abdominal incisions, and recovery time, introducing procedural risks and increasing healthcare costs. FemBloc is a first-of-its-kind, non-surgical solution designed to address this unmet need in women’s reproductive health. Using a patented delivery system, FemBloc places a proprietary blended polymer into both fallopian tubes, where it safely degrades and forms natural scar tissue for permanent occlusion. By eliminating the complexities associated with surgical sterilization, FemBloc has the potential to expand access to permanent contraception while reducing the burden on healthcare systems. Millions of women worldwide undergo surgical procedures for permanent birth control each year, highlighting the need for a non-surgical alternative.

About the FINALE Pivotal Clinical Trial
The FINALE (Prospective Multi-Center Trial for FemBloc INtratubal Occlusion for TranscervicAL PErmanent Birth Control) trial is a prospective, multi-center, open-label, single-arm pivotal study evaluating the safety and effectiveness of FemBloc. An initial roll-in enrollment of 50 women was completed to assess preliminary safety data, together with data from prior IDE-approved studies, after which the U.S. Food and Drug Administration (FDA) authorized continuation of the trial to enroll the remaining participants. The primary endpoint is pregnancy rate, assessed after 401 women have used FemBloc for one year, with an interim analysis planned after 300 participants complete one year of use. Participants will be followed annually for five years post-procedure. For more information, visit .

About Femasys
Femasys is a leading biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its broad, patent-protected portfolio of novel, in-office therapeutic and diagnostic products. As a U.S. manufacturer with global regulatory approvals, Femasys is actively commercializing its lead product innovations in the U.S. and key international markets. Femasys’ fertility portfolio includes FemaSeed

Intratubal Insemination (ITI), a groundbreaking first-step infertility treatment; FemSperm , a CLIA waived sperm preparation and analysis product line; and FemVue , a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrate that FemaSeed achieved more than double the pregnancy rates of traditional IUI, with a comparable safety profile and high patient and practitioner satisfaction.

FemBloc

permanent birth control is the first and only non-surgical, in-office alternative to centuries-old surgical sterilization that received full regulatory approval in Europe in June 2025, the UK in August 2025, and New Zealand in September 2025. Commercialization of this highly cost-effective, convenient and significantly safer approach will be completed through strategic partnerships in select European countries. Alongside FemBloc, the FemChec , diagnostic product provides an ultrasound-based test to confirm procedural success. Published data from initial clinical trials demonstrated compelling effectiveness, five-year safety, and high patient and practitioner satisfaction. For U.S. FDA approval, enrollment in the FINALE pivotal trial (NCT05977751) is on-going.

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