FEMASYS INC

Femasys Inc. (NASDAQ: FEMS) is a woman-founded and woman-led biomedical company focused on developing and commercializing innovative solutions for women's reproductive health. The company operates through a portfolio of FDA-cleared and internationally approved products addressing significant unmet needs in infertility treatment and permanent birth control.

The company's primary product, FemaSeed Intratubal Insemination, represents a breakthrough in artificial insemination by delivering sperm directly to the fallopian tube, the natural site of conception. FemaSeed is FDA-cleared in the United States and approved in Europe, the United Kingdom, Canada, Israel, Australia, and New Zealand. The FemaSeed portfolio is complemented by FemVue, a companion diagnostic device for fallopian tube assessment via ultrasound, and FemSperm, a family of kits enabling gynecologists to perform in-office sperm preparation and analysis. These products target the infertility market, which Femasys estimates represents an immediately addressable market of over one billion dollars in the United States.

Femasys's second major product candidate, FemBloc, is a revolutionary non-surgical permanent birth control solution utilizing a minimally invasive delivery system for synthetic tissue adhesive placement into both fallopian tubes. FemBloc received CE mark certification under European Union Medical Device Regulation in 2025 and regulatory approvals in the United Kingdom and New Zealand. The company received FDA approval in November 2025 to advance to the final phase of its pivotal clinical trial for U.S. approval, with enrollment initiated in March 2026. FemBloc is complemented by FemChec, a companion diagnostic for ultrasound-based confirmation of tubal occlusion. The company estimates the U.S. market for FemBloc may exceed twenty billion dollars.

Additional products include FemCerv, an endocervical tissue sampler for cervical cancer diagnosis, and FemCath, a selective fallopian tube evaluation device. All products are manufactured at the company's facility in compliance with FDA and international manufacturing standards. Femasys maintains an extensive intellectual property portfolio comprising approximately 228 issued patents globally. The company has established commercial partnerships with prominent infertility centers and distribution partners across key markets. Visit www.femasys.com for additional information.