Femasys secures EU green light for birth control device in bid for growth

Femasys (NASDAQ: FEMY), a small US-based medical technology firm, has secured its first regulatory approval in Europe for FemBloc, a non-surgical permanent birth control device for women. The European Medicines Agency has granted the product a CE mark certification, allowing it to be marketed across all 27 EU member states and three European Free Trade Association countries. The company is also advancing its late-stage pivotal trial in the US, where it has received investigational device exemption (IDE) status from the FDA.

Analysts project FemBloc could generate $7 million in revenue by 2027, with sales potentially rising to $138 million by 2032.

Femasys is also seeing momentum from FemaSeed, its FDA-approved infertility treatment. The product is expected to contribute the bulk of near-term revenues, generating $5 million in 2025 and potentially reaching $270 million by 2032, according to analyst estimates. Overall, the company’s revenue is forecast to climb to $6 million in 2025 from $2 million in 2024, marking the early stages of what it hopes will be a commercial breakthrough.