IceCure Medical’s tumor-freezing treatment ProSense has nabbed FDA approval, making it the first medical device of its kind to be endorsed for the local treatment of breast cancer.
The Israeli medical technology company saw its shares jump more than 17% afterhours Friday, Oct. 3, after the company announced the approval. Shares lost some of their gains by Monday morning and were trading up about 8% from Friday's close.
Treatment with ProSense involves a minimally invasive outpatient procedure that aims to destroy tumors by freezing them, all without the need for surgical removal of breast tissue. This approach also allows for "excellent" cosmetic results and "minimal" scarring, according to IceCure.
The specific FDA license allows the ProSense procedure to be used for local treatment of early-stage, low-risk breast cancer—when combined with adjuvant endocrine therapy—in women 70 and older. IceCure figures this works out to a patient population of about 46,000 women annually in the U.S.
IceCure will, however, have to carry out a postmarket surveillance study at the behest of the FDA to produce “additional data” in this indication.
There are several other similar cryoablation treatments, though not in the specific indication IceCure has gained. These include the ISOLIS Cryoprobe system from Varian Medical Systems, which is combined with the myNeedle laser navigation system from Siemens Healthineers; the V-Probe from Varian Medical Systems; and the ICEfx system from Boston Scientific.
“We are excited to add a minimally invasive choice around breast cancer treatments and to offer patients an effective, outpatient procedure,” Eyal Shamir, CEO of IceCure, said in a statement.
“With the ProSense Cryoablation System, we are giving women with low-risk, early-stage breast cancer the choice to freeze their cancer, not their lives, through an effective treatment that minimizes recovery time, and minimal cosmetic changes to the breast," Shamir added.