Femasys Inc

The FDA has approved the modular premarket approval (PMA) pathway for FemBloc from Femasys, allowing the agency to review key components of the application before final clinical data are complete. FemBloc is a non‑surgical, permanent contraceptive technology that introduces a polymer filler into both fallopian tubes to create a permanent occlusion. The product is already approved in Europe, the UK and New Zealand; Femasys is advancing U.S. approval through the ongoing FINALE study and is building a U.S. commercial sales team. » Plus sur de.investing.com

Femasys reports the grant of patents for the polymer blend of its non‑surgical contraception solution FemBloc in the US, Japan, South Korea, Brazil, Hong Kong, India and numerous European countries. The new patents complement existing protection for the delivery system and expand the intellectual property coverage for the FemBloc solution. FemBloc is approved in Europe, the UK and New Zealand and is undergoing regulatory‑relevant studies in the US; Femasys is simultaneously focusing on commercializing its fertility portfolio, including FemaSeed. » Plus sur de.investing.com

Femasys completed a $30 million private placement with accredited investors; lead investor is Nantahala Capital, with participation from specialized health funds and members of management. The offering consisted of 9,374,999 common shares and pre-funded warrants sold, plus accompanying warrants for up to 18,749,998 additional shares at prices around $3.20; the pre-funded warrants were priced at $3.1999. Each purchase includes two warrants with a three-year term and a $2.95 exercise price; if all warrants are exercised for cash, up to an additional $60 million could be raised. The securities were not registered under the Securities Act; Femasys intends to file a registration statement for resale. The company develops fertility and contraception products, including FemBloc, which is currently under FDA review in the pivotal FINALE study. » Plus sur de.investing.com