IceCure has received regulatory approval from the Medical Device Division of Israel's Ministry of Health (AMAR) for its next-generation single cryoprobe cryoablation system, the XSense System and CryoProbes.

Speaking in this regard, Eyal Shamir, Chief Executive Officer (CEO), IceCure, stated, "We believe that this latest regulatory approval for our next-generation cryoablation system reaffirms IceCure's leadership position in liquid nitrogen-based cryoablation. The minimally invasive cryoablation option that we offer across a broad range of indications can de-escalate cancer care, reduce treatment costs for payers and accelerate recovery time for patients."

XSense is now approved in Israel for all indications for which ProSense has already received approval in Israel, including general surgery, dermatology neurology, including cryoanalgesia, thoracic surgery, ENT (Ear, Nose, Throat), gynaecology, oncology (including benign and malignant breast tumors), proctology and urology.

"We are particularly pleased with the breast cancer indication approval in Israel, as we believe the growing body of evidence on cryoablation as a minimally invasive option for breast cancer supports accelerated commercial adoption," Shamir added.