FDA Approves Final Trial Phase for Femasys’ Permanent Birth Control Product

Femasys Inc. has secured U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval to continue enrollment in the final phase (Part B) of its FINALE pivotal trial for FemBloc. The approval follows the successful completion of the first part of the multi-stage trial design and represents a critical (and necessary) step towards potential U.S. Pre-Market Approval (PMA).

Femasys also announced plans (under an agreement with several investors) to issue $12 million of senior secured convertible notes and accompanying warrants to purchase common stock for a possible $58 million if all warrants are exercised for cash. The proceeds will be used to refinance existing debt and advance commercialization of Femasys’ fertility and permanent birth control portfolio.

“This FDA IDE approval represents a critical milestone in advancing FemBloc toward U.S. approval, bringing women a long overdue, non-surgical option for permanent birth control, as women in Europe and other select countries are now beginning to benefit from this important innovation,” Femasys Founder/CEO Kathy Lee-Sepsick stated. “This milestone gives us a clear pathway to potentially achieving U.S. FDA approval and the opportunity to finally make this option available to women in the United States.”

FemBloc is billed as a first-of-its-kind, non-surgical solution for permanent birth control. It uses a patented delivery system to place a proprietary blended polymer into both fallopian tubes, which safely degrades and forms natural scar tissue for permanent occlusion. Unlike surgical sterilization, FemBloc requires no anesthesia, incisions, or recovery time, avoiding the risks of infection and other surgical complications while providing women a safer, more convenient, and affordable option, according to the company. With no comparable alternatives on the market, Femasys claims FemBloc represents a disruptive advancement with broad global potential.

“I am proud to continue supporting Femasys as it advances solutions in women’s health,” said Jorey Chernett, founder/CEO of Clearpath and managing member of Pointillist Family Office. “The recent FDA IDE approval to advance FemBloc’s final pivotal trial phase reinforces the company’s progress toward bringing this option to women in the U.S. Having witnessed firsthand the risks women have historically faced, I believe FemBloc and FemaSeed represent transformative innovations that redefine the standard of care. This financing reflects my confidence in Femasys’ leadership and strategy, and I believe the company’s platform offers sustainable competitive advantages and is positioned to deliver meaningful impact for women while creating long-term value for shareholders in a multi-billion-dollar market.”

The Notes bear interest at a rate of 8.5% per annum and have a 10-year maturity. The Notes will be convertible into up to an aggregate of 16.3 millionshares of Femasys common stock at the conversion price equal to $0.73 per share of common stock, which represented a 15% premium to the closing price of Femasys’ common stock immediately before entering into the definitive agreement. As part of the private placement, Femasys also issued warrants to purchase additional shares of Femasys common stock comprising of an A-1 Warrant exercisable into an aggregate of 16.3 million shares at an exercise price equal to $0.81 per share, subject to adjustments, exercisable for 10 years from the issue date; a B-1 Warrant, exercisable into an aggregate of 16.3 million shares at an exercise price equal to $0.92 per share, subject to adjustments, exercisable for 10n years from the issue date; and a C-1 Warrant, exercisable into an aggregate of 16.3 million shares at an exercise price equal to $1.10 per share, subject to adjustments, exercisable for 10 years from the issue date. If exercised for cash, these warrants could result in proceeds up to an additional $46 million, bringing total potential proceeds to $58 million.

“… this financing strengthens our capital position and provides stability to accelerate growth and create lasting value as we transform women’s health. Our investors recognize the significant opportunity to profoundly impact women’s reproductive care by potentially introducing FemBloc as a safe and effective alternative to surgical sterilization, the only permanent contraceptive option currently available in the U.S.,” Lee-Sepsick commented. “We believe our innovations in birth control and fertility have the potential to redefine care for millions of women worldwide and establish Femasys as a leader in women’s health innovation.”

Femasys is a biomedical innovator focused on making fertility and non-surgical permanent birth control more accessible and cost-effective for women worldwide through its patent-protected portfolio of 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 United States and key international markets. Femasys’ fertility portfolio includes FemaSeed Intratubal Insemination, a first-step infertility treatment and FemVue, a companion diagnostic for fallopian tube assessment. Published clinical trial data demonstrates FemaSeed is over twice as effective as traditional IUI, with a comparable safety profile, and high patient and practitioner satisfaction.¹

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, the U.K. 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.² For FDA approval, enrollment in the FINALE pivotal trial is on-going.

References
¹ 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.
² 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.