FDA OKs IceCure’s Next-Gen Cryoablation System

IceCure Medical has earned U.S. Food and Drug Administration (FDA) marketing authorization for its next-gen single-probe cryoablation system, the XSense cryoablation system with CryoProbes.

The Israel-based company’s platform technology includes both the ProSense cryoablation system and XSense. They offer a minimally invasive treatment to destroy tumors by freezing them, using liquid nitrogen to make large lethal zones to destroy benign and cancerous lesions, including breast, kidney, lung, and liver.

IceCure touts its minimally invasive tech as a safe, effective alternative to hospital surgical tumor removal. The company said its cryoablation procedure is easily performed in a relatively short procedure.

XSense and its cryoprobes are cleared for all the indications ProSense already has: general minimally invasive cryoablation in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system can destroy tissue by applying extreme cold temperatures, including fibroadenomas, kidney tissue, liver metastases, tumors, skin lesions, and warts.

“This latest FDA regulatory clearance further validates the safety and efficacy of our platform cryoablation technology,” said Eyal Shamir, IceCure’s CEO. “The next-generation XSense system is cleared for the same indications as our flagship ProSense system and we believe it has future potential to address other indications in the U.S. for significant indications with unmet needs. Through our innovation, IceCure is a global leader in liquid nitrogen-based cryoablation systems that offer a new minimally invasive treatment with benefits for patients, doctors and payors alike.”