On September 12, 2024 IceCure Medical Ltd. (Nasdaq: ICCM) ("IceCure", "IceCure Medical" or the "Company"), developer of minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, reported the U.S. Food and Drug Administration’s ("FDA") Medical Device Advisory Committee Panel (the "Advisory Panel") is scheduled to take place on Thursday, November 7, 2024 (Press release, IceCure Medical, SEP 12, 2024, View Source [SID1234646548]). The purpose of the Advisory Panel is for the FDA to obtain independent expert advice on scientific, technical and policy matters related to the De Novo Classification Request for marketing authorization of ProSense for the indication of treating patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy.
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"This public forum transparency ensures key stakeholders, including women with early-stage low risk breast cancer, their doctors and payors, can exchange views and data regarding the potential benefits of minimally invasive cryoablation with ProSense as an alternative to surgery," stated IceCure’s CEO, Eyal Shamir. "Following the Advisory Panel, we anticipate that the FDA will make a decision regarding marketing clearance of ProSense by early 2025."
The Advisory Panel will include breast surgeons, interventional radiologists and industry representatives from the regulatory community. The vast body of data available on ProSense as a treatment for early-stage low risk breast cancer will be reviewed by the Advisory Panel, including results from the Company’s ICE3 study, the largest controlled multicenter clinical trial ever performed for liquid nitrogen-based cryoablation of early-stage malignant breast tumors. Per the analysis, at the 5-year follow-up evaluation, 96.3% of the subgroup of patients treated with ProSense cryoablation, followed by adjuvant endocrine therapy, were estimated to be free from local recurrence. 100% patient and physician satisfaction was reported. The Advisory Panel is expected to make its recommendations at the conclusion of the meeting, at which time the FDA will commence its review process.
The FDA generally makes Advisory Panel meeting materials and the live webcast link available to the public no later than two business days before the meeting, at which time IceCure intends to share the link with shareholders via a press release.
About ProSense
The ProSense Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense opens that door to fast and convenient office-based procedure for breast tumors.