Why Femasys Shares Are On The Move Monday

Femasys Inc FEMY shares are trading higher Monday after the company announced that it received an Investigational Device Exemption (IDE) approval from the FDA to evaluate FemBloc in a pivotal clinical trial.

What To Know: FemBloc is a non-surgical, non-implant, in-office solution for permanent birth control. Femasys plans to initiate a pivotal trial to evaluate the safety and efficacy of FemBloc in the third quarter. 

401 women will be analyzed after using FemBloc for one year permanent birth control and pregnancy rate will be the primary endpoint. An interim analysis of clinical data endpoints is planned once 300 women have used FemBloc.

"FemBloc has been designed to be a solution that provides an alternative to surgical tubal ligation (or tying a woman's tubes), thus reducing the unnecessary risks and substantial cost associated with surgery," said Kathy Lee-Sepsick, founder, president and CEO of Femasys.

"In addition, FemBloc could provide an option to women using temporary birth control methods long term that may require implants or hormones."

Femasys is a biomedical company developing a suite of product candidates that include minimally invasive, in-office technologies for reproductive health.

See Also: Why CollPlant Biotechnologies Stock Is Trading Higher

FEMY Price Action: Femasys shares were up 30.8% at 80 cents Monday morning, according to Benzinga Pro.

Photo: StockSnap from Pixabay.