FDA Advisory Panel to Review IceCure's ProSense for Early-Stage Breast Cancer
核心洞察
The FDA's Medical Device Advisory Committee will review IceCure's ProSense (搜索) cryoablation system for early-stage, low-risk breast cancer (搜索) on November 7, 2024.
The advisory panel will provide recommendations on the benefit-risk profile of ProSense (搜索) for treating early-stage invasive breast cancer (搜索) with cryoablation and adjuvant endocrine therapy.
Public comments from stakeholders, including patients and healthcare professionals, are available on the FDA website for the advisory panel's consideration.
IceCure Medical Ltd. (NASDAQ: ICCM) announced that the FDA's Medical Device Advisory Committee Panel is scheduled to convene on November 7, 2024, to review the marketing authorization of ProSense (搜索) cryoablation system for early-stage, low-risk breast cancer (搜索).
The advisory panel aims to provide the FDA with independent expert advice on scientific, technical, and policy matters concerning the potential approval of ProSense (搜索) for treating patients with early-stage low-risk invasive breast cancer (搜索) using cryoablation combined with adjuvant endocrine therapy. The panel will consist of breast surgeons, interventional radiologists, regulatory community representatives, and other experts.
Public Comments and Stakeholder Input
Ahead of the meeting, a substantial number of public comments from key stakeholders have been posted on the FDA website. These comments offer diverse perspectives from breast cancer (搜索) patients, oncologists, surgeons, radiologists, nurses, researchers, and others who express support for ProSense (搜索) as a treatment option. The public docket for ProSense is accessible at https://www.regulations.gov/docket/FDA-2024-N-4057, and a live webcast of the advisory panel meeting will be available at https://www.youtube.com/watch?v=PMS5dJRtLIo.
ProSense Cryoablation System
ProSense (搜索) is a minimally invasive cryoablation system that destroys tumors by freezing them. It utilizes liquid nitrogen to create large lethal zones, maximizing efficacy in tumor destruction in both benign and cancerous lesions, including those in the breast, kidney, lung, and liver. IceCure Medical emphasizes that ProSense enhances patient and provider value by accelerating recovery and reducing pain, surgical risks, and complications. Its design facilitates convenient office-based procedures for breast tumors.
Company Perspective
"We are highly encouraged by the large number of comments received for the Advisory Panel's consideration regarding the role of ProSense (搜索) as a minimally-invasive treatment option for early-stage low risk breast cancer (搜索) patients. Key stakeholders, including breast cancer patients, have shared their first-hand experience with ProSense," stated IceCure's CEO, Eyal Shamir. "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."