IceCure Medical Gathers Strong Stakeholder Feedback Ahead of FDA Panel Review for ProSense® Cryoablation System; Shares Rise 21%”

IceCure Medical Ltd. (NASDAQ: ICCM) announced that a significant number of public comments from stakeholders, including doctors, nurses, researchers, and breast cancer patients, have been posted ahead of an upcoming FDA Advisory Panel meeting. The panel, scheduled for November 7, 2024, will review and provide recommendations on the benefit-risk profile of IceCure’s ProSense® Cryoablation System for early-stage, low-risk breast cancer treatment as part of a De Novo marketing submission. Shares of IceCure are up 21% following the announcement, and the company is currently leading the PRISM Med Devices Index.

IceCure’s CEO, Eyal Shamir, commented, “We are highly encouraged by the large number of comments received for the Advisory Panel’s consideration regarding the role of ProSense® as a minimally-invasive treatment option for early-stage low-risk breast cancer patients. Key stakeholders, including breast cancer patients, have shared their first-hand experience with ProSense®. We look forward to the public forum on November 7, along with the Advisory Panel’s vote, which the FDA will consider in making its decision, expected by early 2025.”

The Advisory Panel will consist of breast surgeons, interventional radiologists, regulatory representatives, and other experts. Comments are available for public view on the FDA website, and the meeting will be livestreamed. The FDA is expected to make a decision on marketing authorization by early 2025.