IceCure Medical Files for FDA Clearance for Next-Gen Cryoablation System

IceCure Medical Ltd. (Nasdaq: ICCM) has filed a 510(k) submission with the FDA for clearance of its next-generation single probe cryoablation system, the XSense™ System and cryoprobes.

“As our ProSense® single probe cryoablation system builds market traction globally, we continue to develop our technology pipeline with innovative single and multi-probe systems,” commented IceCure’s CEO, Eyal Shamir.

“We believe IceCure is the technological, clinical and market leader in liquid nitrogen-based cryoablation technologies that can have a significant beneficial impact on global healthcare systems by offering safe, effective, patient-friendly and cost-efficient alternatives to more invasive surgical procedures.”

The filing contains a request for clearance for the XSense System in indications including general minimally invasive cryoablation applications for the kidney, liver, fibroadenomas and neurology. IceCure’s ProSense® system has already received FDA clearance for these indications.

IceCure’s ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them in a fast and convenient office-based procedure.

About IceCure Medical

IceCure Medical (Nasdaq: ICCM) develops and markets ProSense®, an advanced liquid-nitrogen-based cryoablation therapy for the treatment of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and China.