Femasys Inc., a biomedical innovator focused on advancing women’s reproductive health, has achieved a key milestone in its FemBloc FINALE pivotal trial, marking significant progress toward potential U.S. Pre-Market Approval (PMA) for FemBloc, its groundbreaking nonsurgical permanent birth control solution. Designed as a safe, accessible, and office-based alternative to surgical sterilization, FemBloc represents a paradigm shift in permanent contraception. Alongside this clinical advancement, Femasys recently secured $12 million in financing, with potential proceeds of up to $58 million, to support commercialization and market readiness efforts globally.

In this exclusive interview with MedTech Spectrum, Kathy Lee-Sepsick, CEO of Femasys, discusses the clinical and strategic importance of this milestone, the innovation behind FemBloc’s technology, and how the company is expanding its broader portfolio to redefine accessibility and affordability in women’s reproductive healthcare.

Could you elaborate on what this milestone means for Femasys and how it positions FemBloc on the path toward potential U.S. Pre-Market Approval?

The FemBloc FINALE pivotal trial was designed in two stages, requiring completion of Part A and FDA approval to proceed to Part B. Achieving this milestone allows us to advance to the final stage of the study, where the primary endpoint (pregnancy rate in 401 women relying on FemBloc for one year) will be evaluated. This progress moves FemBloc closer to completing the pivotal trial necessary for U.S. Pre-Market Approval (PMA).

FemBloc represents a significant shift in permanent birth control, offering a nonsurgical alternative to tubal ligation. What inspired the development of this technology, and how does it differ mechanistically and clinically from current options available to women?

I founded Femasys out of personal frustration with the limited permanent contraceptive options available to women. With my background, I was confident we could create a safe and effective alternative. Unlike surgical sterilization, FemBloc is a completely non-surgical approach that greatly reduces patient risk. It also has the potential to significantly lower healthcare costs by offering an innovative, office-based procedure that requires no anesthesia, incisions, hormones, or implants.

The FINALE trial features a multi-stage design. What insights or safety and efficacy data from Part A informed the transition into Part B, and what key endpoints or outcomes are being prioritised in this final phase?

Part A included 50 women and was primarily focused on establishing safety and demonstrating preliminary effectiveness. Based on those positive results, the FDA approved advancement to Part B. The final phase will evaluate a total of 401 women relying on FemBloc for permanent birth control over one year, with the primary endpoint being the pregnancy rate required to meet the statistical standards for FDA Pre-Market Approval.

Alongside the FDA IDE approval, Femasys announced a $12 million financing round with potential proceeds of up to $58 million. How will these funds support your near-term priorities, particularly in clinical advancement, commercialisation, and global market readiness?

This financing enabled us to strengthen our balance sheet by repaying existing debt and further capitalizing the company. The proceeds will support commercialization efforts, including the launch of FemBloc in select European countries and FemaSeed, our next-generation artificial insemination product, in the U.S. With FemaSeed utilizing a similar delivery platform as FemBloc, this launch also helps prepare the U.S. market for FemBloc’s future introduction.

A key part of Femasys’ mission is to make fertility and permanent birth control more accessible and cost-effective. How does FemBloc align with that vision, and what strategies are in place to ensure equitable access once approved?

FemBloc offers a non-surgical alternative to the only permanent birth control option currently available, surgical sterilization. By being performed in a gynecologist’s office without the need for surgery or anesthesia, FemBloc has the potential to greatly expand access while reducing costs. This office-based approach supports our mission to make permanent birth control more accessible, affordable, and equitable for women worldwide.

Beyond FemBloc, Femasys is advancing a broader portfolio in women’s reproductive health. What upcoming innovations or strategic initiatives can we expect as the company continues to expand its leadership in this space?

Femasys is preparing to launch FemaSeed, our intratubal insemination solution, together with our FemSperm product line for sperm preparation and analysis. FemSperm enables gynecologists, who currently do not have the capability to handle sperm, to offer fertility treatment directly to their patients in their offices. Today, women are referred to a specialist for these services. By equipping gynecologists to provide this care, we can greatly expand accessibility for the millions of women struggling with infertility, advancing our mission to make reproductive healthcare more inclusive, accessible, and affordable.