Femasys Secures €12M Funding, Expands Non-Surgical Birth Control Reach in Europe

November 10, 2025 – Femasys Inc. (NASDAQ: FEMY) announced today a €12 million financing round and continued expansion of its FemBloc device across Europe, positioning the company as a key player in the evolving landscape of permanent contraception. The non-surgical approach to fallopian tube occlusion is gaining traction as a less invasive alternative to traditional methods, with recent regulatory approvals in Europe, the UK, and New Zealand paving the way for broader market access.

FemBloc utilizes a proprietary blended polymer delivered directly into the fallopian tubes, creating a natural healing response and permanent blockage without the need for incisions, anesthesia, or a prolonged recovery period. This contrasts sharply with the established method of surgical tubal ligation, which carries inherent risks and requires significant downtime.

Disrupting a Traditional Market

The existing birth control market is dominated by hormonal methods, IUDs, and surgical sterilization. While effective, surgical tubal ligation carries a pregnancy rate of around 6% over five years, alongside risks associated with any surgical procedure. Femasys’s clinical trials, published in the Journal of Gynecology & Reproductive Medicine, demonstrated a 0% pregnancy rate among eligible participants with bilaterally occluded fallopian tubes three months post-procedure – a compelling statistic that’s attracting attention from both clinicians and patients.

“There’s a clear demand for less invasive options in permanent contraception,” explains an anonymous reproductive endocrinologist familiar with the technology. “Patients are increasingly seeking alternatives that minimize risk and recovery time, and FemBloc appears to address those concerns effectively. The fact that it’s an in-office procedure is a significant advantage.”

European Approvals & Expansion Strategy

The company secured full regulatory approval for FemBloc in Europe in June 2025, followed by approvals in the UK and New Zealand, demonstrating a swift rollout following successful clinical trials. The recent financing round will fuel further expansion across these markets, as well as support ongoing clinical trials in the United States.

“The European regulatory approvals are a major milestone for Femasys,” notes an industry analyst. “It validates the technology and opens up a significant market opportunity. The company is strategically focused on expanding access to FemBloc, and this financing round provides the resources to accelerate that process.”

Financial Performance and Future Outlook

Femasys reported sales of €554,908 in the third quarter of 2024, a 127.1% increase compared to the same period last year. However, the company continues to operate at a net loss, reporting €5.4 million in losses for the quarter. Despite this, analysts remain optimistic, citing the potential for rapid revenue growth as FemBloc gains wider adoption.

“The company is still in a growth phase, and losses are expected,” explains an anonymous financial analyst. “However, the potential market for FemBloc is substantial, and the company is well-positioned to capitalize on that opportunity. The recent financing round provides a crucial runway for continued development and commercialization.”

Femasys is currently enrolling participants in the FINALE trial (NCT05977751), a pivotal U.S. study designed to secure FDA approval. The trial is expected to enroll 573 women and assess the safety and efficacy of FemBloc over one year. An interim analysis is planned at the 50-participant checkpoint, offering early insights into the device’s performance.

Reimbursement Challenges & Market Access

Despite the positive clinical data and regulatory approvals, market access for FemBloc isn’t without its challenges. Reimbursement policies for medical devices vary significantly across European countries, and securing coverage for a relatively new technology can be complex.

In France, innovative medical devices may initially be added to an ‘add-on list’ to provide financial incentives for hospitals to use them, while the Netherlands has a complex reimbursement landscape where contraceptive coverage is often dependent on age and insurance policies.

“Reimbursement will be crucial for driving adoption of FemBloc,” explains an anonymous healthcare economist. “The company will need to demonstrate the cost-effectiveness of the device and work closely with healthcare authorities to secure favorable coverage policies.”

Looking Ahead: A Promising Future for Non-Surgical Contraception

Femasys’s FemBloc represents a significant step forward in permanent contraception, offering a less invasive, more convenient option for women seeking long-term birth control. While challenges remain in terms of reimbursement and market access, the company is well-positioned to capitalize on the growing demand for non-surgical alternatives.

The company's expansion across Europe, coupled with the ongoing U.S. clinical trials, signals a promising future for FemBloc and the broader field of non-surgical contraception. As more women become aware of the benefits of this innovative technology, it’s likely to disrupt the traditional birth control market and empower women to make informed decisions about their reproductive health.

“We are witnessing a paradigm shift in contraception,” concludes an anonymous physician. “Women are demanding more choices, and technologies like FemBloc are providing those options. It’s an exciting time for the field, and I believe we’ll see continued innovation in the years to come.”