Why Is Medical Device Firm IceCure Medical Stock Trading Lower Today?

The FDA has denied IceCure Medical Ltd's ICCM De Novo Classification request for the ProSense System for breast cancer, which was submitted based on interim analysis from its ICE3 study. 

ProSense cryoablation (a procedure that uses cold to treat cancer) is a minimally invasive, non-surgical, outpatient 40-minute procedure requiring only a local 1% lidocaine injection. 

The FDA's position on the De Novo Classification request for breast cancer does not affect ProSense's FDA-cleared authorization for other indications in the U.S., and patients in the U.S. continue to have access to ProSense for those treatments. 

IceCure is pursuing to address the FDA's response. It had filed the De Novo request with the FDA in October 2022 based on interim data from its ICE3 breast cancer study for the Breakthrough Indication of early-stage (Luminal A T1 invasive) low-risk breast cancer patients who are at high risk to surgery (not suitable for surgical alternatives). 

IceCure continues its ICE3 clinical study, which is expected to be completed during the first quarter of 2024.

Cryoablation costs less than the current standard of care breast cancer surgery of lumpectomy or partial mastectomy, which requires general anesthesia and has cosmetic consequences.

Price Action: ICCM shares are down 35.80% at $0.58 on the last check Wednesday.