Analyst Emily Bodnar of H.C. Wainwright maintained a Buy rating on Femasys (FEMY – Research Report), retaining the price target of $12.00.
Emily Bodnar’s rating is based on Femasys’s recent achievement of obtaining CE mark certification for its FemBloc delivery system under the European Union Medical Device Regulation. This regulatory approval is a significant milestone as it marks the first-ever approval for the FemBloc delivery system globally, allowing Femasys to pre-market the device and increase product awareness in Europe.
Additionally, the company’s strategic plans to launch in key European markets such as Spain, France, Italy, and Germany, coupled with the expansion of its salesforce, are expected to drive potential sales in late 2025 to early 2026. The quicker-than-expected approval in Europe, ahead of the ongoing pivotal study in the US, is seen as a positive development, enhancing the prospects for FemBloc’s commercial success. Furthermore, Femasys’s strategy to partner with distributors and leverage experienced personnel from Essure’s international sales force is anticipated to facilitate a successful market entry. Overall, these factors contribute to the optimistic outlook for Femasys, justifying the Buy rating.