For decades, permanent contraception options for women have been limited to surgical sterilization, which is an invasive procedure that carries risks, requires recovery time, and may not be easily accessible. Femasys, under the leadership of CEO and Founder Kathy Lee-Sepsick, is changing this landscape with FemBloc, the first non-surgical, non-implant, hormone-free permanent birth control option. With CE mark approval already secured, the company is preparing for a commercial rollout in Europe, where France has emerged as the largest market opportunity due to its high contraceptive usage and limited permanent alternatives.
In an interview with Medtech Spectrum, Kathy Lee-Sepsick discusses why France is such a strategic market, how the partnership with Kebomed will help accelerate adoption, and the company’s broader roadmap to bring FemBloc to women around the world.
France is described as the largest single-market opportunity for FemBloc in Europe. Could you elaborate on what makes this market particularly strategic and how you plan to drive adoption there?
France is one of Europe’s largest healthcare markets and demonstrates a high level of overall access to contraception, ranking first among European countries¹. Data from 2019 further show that 65 per cent of women of reproductive age use contraceptives, above the European average of 56.1 per cent.2 Despite this high overall use, permanent options remain limited to surgical sterilization, highlighting a clear gap. FemBloc, as the first permanent option that does not require surgery, implants, or hormones, directly addresses this need and positions France as the single largest opportunity in Europe.
Reference:
Contraception Policy Atlas Europe 2025, https://www.epfweb.org/sites/default/files/2025-02/CCInfoEU_A3_EN_2025_FEB14%20BIS_0.pdf
CRA/Organon, Policies to Improve Access to LARCs – France Profile (May 2025).
What specific strengths does Kebomed bring to this collaboration, and how will their expertise and network accelerate the commercialization of FemBloc in France and Benelux?
Kebomed has deep expertise in women’s health, local offices in France and Benelux, and trusted relationships with gynecologists. Their infrastructure and clinical network currently support their breadth of women’s health products. An experienced local partner enables faster adoption than going to market on our own.
FemBloc is positioned as the only non-surgical permanent birth control option. How does this innovation address current gaps or limitations in women’s reproductive healthcare?
Currently, surgical sterilization is the only permanent birth control available. FemBloc removes the need for surgery, anesthesia, implants, and recovery, while also avoiding hormones, delivering a safer, more accessible, and cost-effective option for women and healthcare systems.
Following the CE mark approval, what additional steps are necessary to ensure smooth market entry, and what kind of initial feedback or interest are you seeing from healthcare providers in Europe?
The focus now is on physician training and reimbursement. Early feedback from European clinicians has been very positive; they see FemBloc as a needed alternative to surgery. As part of our launch, we will also conduct the required post-market surveillance and are placing strong emphasis on data capture, which will not only support regulatory obligations but also help inform the broader market and reinforce FemBloc’s value proposition.
Introducing a novel solution in women’s health often comes with barriers—whether educational, regulatory, or cultural. What challenges do you foresee, and how are you addressing them to encourage adoption?
We view education and reimbursement not as barriers, but as opportunities to partner with physicians, payers, and regulators. By investing in strong physician training, localized outreach, and leveraging Kebomed’s on-the-ground expertise, we are creating the foundation for broader adoption and long-term success.
Beyond France and Benelux, what is Femasys’ broader roadmap for FemBloc’s expansion across Europe and globally?
Spain will be our first launch market, followed by France, with Benelux also underway. From there, we plan to expand into additional select European markets based on partner selection. At the same time, we continue to pursue regulatory approvals in other key regions, while our pivotal trial in the U.S. advances toward FDA approval. Our long-term vision is to make FemBloc globally accessible wherever women need a safe, non-surgical option for permanent birth control.
