Femasys Announces FemBloc Permanent Birth Control Has Achieved MDSAP Certification, Advancing Global Market Access

-- FemBloc becomes the latest Femasys product to achieve MDSAP certification, building on a proven track record of compliance --

ATLANTA, Feb. 26, 2026 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical innovator making fertility and non-surgical permanent birth control more accessible and cost-effective to women worldwide, announced today that its FemBloc permanent birth control system has achieved certification under the Medical Device Single Audit Program (MDSAP). The MDSAP certification positions the Company to accelerate regulatory and commercial execution across key global markets, including the United States, Canada, Japan, Australia, and Brazil. In the U.S., FDA recognition of MDSAP reflects a high level of quality system maturity and supports regulatory readiness as the Company advances its pivotal clinical trial toward PMA submission. Internationally, the certification enhances manufacturing credibility and operational scalability, supporting ongoing commercialization in Europe and enabling more efficient market entry in additional high-value regions. Overall, MDSAP certification reduces regulatory risk, reinforces manufacturing readiness, and advances the Company’s global expansion strategy.

“Achieving MDSAP certification is a significant milestone for FemBloc and expands our pathway into key international markets,” said Kathy Lee-Sepsick, Chief Executive Officer and Founder of Femasys Inc. “This certification aligns FemBloc with our established, MDSAP-certified portfolio and reflects the strength of our U.S. based manufacturing platform. Importantly, it enhances our global scalability, supports future U.S. commercialization, and strengths our ability to pursue strategic partnerships as we target a substantial global market that remains both underserved and significantly underpenetrated.”

Permanent birth control is one of the most widely utilized contraceptive methods worldwide, yet current options remain surgical, requiring anesthesia, abdominal incisions, and post-procedure recovery, which introduce procedural risks and increase healthcare costs. FemBloc is a first-of-its-kind, non-surgical solution for permanent birth control designed to address this significant 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 risks and complexities associated with surgical sterilization, FemBloc provides women a safer, more convenient, and affordable option. FemBloc has the potential to expand access to permanent contraception while reducing the burden on healthcare systems globally.

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.

References

Liu, J. H., Glassner, M., Gracia, C. R., Johnstone, E. B., Schnell, V. L., Thomas, M. A., L. Morrison, Lee-Sepsick, K. (2024). FemaSeed Directional Intratubal Artificial Insemination for Couples with Male-Factor or Unexplained Infertility Associated with Low Male Sperm Count. J Gynecol Reprod Med, 8(2), 01-12. doi: 10.33140/JGRM.08.02.08.

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. doi: 10.33140/JGRM.09.01.05.