Gold is 2025’s best performer. UBS sees more upside
On Friday, H.C. Wainwright analyst Emily Bodnar confirmed a Buy rating on Femasys Inc. (NASDAQ:FEMY) with a steady price target of $12.00. The medical device company, currently trading at $1.40 with a market capitalization of $32 million, has shown strong momentum with a 27% year-to-date return according to InvestingPro data. The endorsement comes as Femasys announced the receipt of CE mark certification for the delivery system of its non-surgical contraceptive, FemBloc, under European Union Medical (TASE:BLWV) Device Regulation (EU MDR) on March 13.
The CE mark certifies that the FemBloc delivery system meets the EU’s health, safety, and environmental protection standards, marking the first regulatory approval for the product globally. This certification enables Femasys to begin pre-marketing activities in Europe to boost product awareness, a significant step given the product’s innovative nature. While the company maintains a healthy current ratio of 3.94, InvestingPro analysis indicates it’s currently burning through cash, a common characteristic for companies in the development phase.
FemBloc consists of a delivery system and a synthetic tissue adhesive, with the latter being classified as Class III, indicating it requires a more thorough regulatory review. Femasys has completed a G12 Special MDR Audit for Class III devices, with the auditing body recommending CE mark approval. The recommendation will be finalized following the European Medical Agency (EMA) review, with the company anticipating the polymer’s approval by mid-2025.
The company plans to launch FemBloc in select European markets, initially targeting Spain, France, Italy, and Germany, which were key markets for the now-discontinued competitor contraceptive Essure. Femasys’ progress in Europe is notably ahead of the United States, where the product is still undergoing a pivotal study.
Bodnar notes the faster-than-anticipated European approval for the delivery system as a positive development. The firm’s confidence in the potential of FemBloc is reflected in the reiterated Buy rating and price target, anticipating the product’s successful entry into the European market. With analyst price targets ranging from $3 to $12 and revenue growth of 15.33% in the last twelve months, investors seeking deeper insights can access additional analysis and 8 more key ProTips through InvestingPro.
In other recent news, Femasys Inc. has achieved significant regulatory milestones with the approval of its women’s health products in both Europe and the UK. The company received the Conformité Européenne (CE) mark for its FemBloc® delivery system, a non-surgical permanent birth control method. This marks the first regulatory approval worldwide for the FemBloc system, a major advancement in the field of permanent contraception. Additionally, Femasys announced UK regulatory approval for its FemaSeed Intratubal Insemination device, FemVue for tubal evaluation, and FemCerv for cervical cancer detection. These products, which are already approved in the US, Europe, Canada, and Israel, will now be available to a broader audience in the UK. The approvals highlight Femasys’ commitment to providing innovative and minimally invasive solutions in women’s health. The company continues to progress with its FDA-approved clinical trials for FemBloc in the United States. These developments represent a significant expansion for Femasys, enhancing its presence in the global market.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.