FDA Advisory Panel Votes in Favor of IceCure's ProSense® Cryoablation Benefit-Risk Profile in Early-Stage Low Risk Breast Cancer
IceCure Medical Ltd. - Ordinary Shares (ICCM)
Company Research
Source: PR Newswire
FDA decision on marketing authorization expected in the first quarter of 2025CAESAREA, Israel, Nov. 8, 2024 /PRNewswire/ -- 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, announced the U.S. Food and Drug Administration's ("FDA") Medical Device Advisory Committee Panel's (the "Advisory Panel") favorable recommendation with 9 panelists voting in favor and 5 voting against the benefit-risk profile of IceCure's ProSense®. The majority of panelists voted that the benefits of IceCure's ProSense® System outweigh the risks when used according to the proposed indications for the treatment of patients with early-stage low risk invasive breast cancer with cryoablation and adjuvant endocrine therapy. Among those that voted "no", there were three who stated that if the FDA applied adequate special controls, this would have swaye
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News
- IceCure Medical to Report Third Quarter 2024 Financial & Operational Results on November 26, 2024 [Yahoo! Finance]Yahoo! Finance
- IceCure Medical to Report Third Quarter 2024 Financial & Operational Results on November 26, 2024PR Newswire
- IceCure's ProSense® Chosen for Breast Cryoablation Study Led by the Prestigious European Institute of Oncology with Sponsorship from the Italian Ministry of Health [Yahoo! Finance]Yahoo! Finance
- IceCure's ProSense® Chosen for Breast Cryoablation Study Led by the Prestigious European Institute of Oncology with Sponsorship from the Italian Ministry of HealthPR Newswire
- IceCure gets favorable FDA AdCom vote for ProSense System [Seeking Alpha]Seeking Alpha
ICCM
Earnings
- 5/28/24 - In-Line
ICCM
Analyst Actions
- 9/12/24 - HC Wainwright
ICCM
Sec Filings
- 11/14/24 - Form SC
- 11/8/24 - Form F-1/A
- 11/8/24 - Form 6-K
- ICCM's page on the SEC website