IceCure Medical Ltd.

The ProSense cryoablation system. [Image from IceCure Medical]IceCure Medical (Nadsaq:ICCM) announced today that the FDA responded affirmatively to a request for supervisory review.

This follows the agency’s 2022 denial of IceCure’s de novo classification request for its ProSense cryoablation system. The Caesarea, Israel-based company sought clearance for ProSense to treat patients with early-stage, low-risk breast cancer. FDA’s affirmative response reopens the de novo file, providing IceCure with a potential pathway to clearance.

ProSense provides a minimally invasive treatment option to destroy tumors by freezing them. It utilizes liquid nitrogen to create large lethal zones for tumor destruction in both benign and cancerous lesions. IceCure lists applications such as breast, kidney, lung and liver tumors.

The platform won FDA investigational device exemption (IDE) in April 2021. IceCure believes it could accelerate recovery while reduci…

IceCure Medical today said it received FDA breakthrough device designation for its ProSense cryoablation system.

ProSense is a liquid nitrogen-based cryoablation system that is a minimally invasive treatment for cancer tumors. It is designed for use in the treatment of TI invasive breast cancer or in patients not suitable for surgical alternatives for treating breast cancer.

“We are thrilled to receive the breakthrough device designation from the FDA for our lead asset, ProSense, based on promising clinical outcomes in multiple clinical studies to date. ProSense has successfully demonstrated the potential to be an exceptionally safe and effective minimally invasive cryoablation approach to tumor destruction. We believe receipt of this designation is a testimony to the potential of ProSense to become the new gold standard for cryoablation tumor therapy,” CEO Eyal Shamir said in a news release.

As part of the breakthrough device program, the Me…