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
- Data on IceCure's ProSense® Cryoablation for Low-Risk Breast Cancer Presented at Radiological Society of North America's 2024 Annual Meeting [Yahoo! Finance]Yahoo! Finance
- Data on IceCure's ProSense® Cryoablation for Low-Risk Breast Cancer Presented at Radiological Society of North America's 2024 Annual MeetingPR Newswire
- IceCure's ProSense® Cryoablation Safe and Effective in Destruction of Kidney Tumors with 88.7% Recurrence-Free Rate Based on Interim ICESECRET Study Results [Yahoo! Finance]Yahoo! Finance
- IceCure's ProSense® Cryoablation Safe and Effective in Destruction of Kidney Tumors with 88.7% Recurrence-Free Rate Based on Interim ICESECRET Study ResultsPR Newswire
- IceCure Medical Ltd (NASDAQ: ICCM) had its "buy" rating re-affirmed by analysts at HC Wainwright. They now have a $2.50 price target on the stock.MarketBeat
ICCM
Earnings
- 5/28/24 - In-Line
ICCM
Analyst Actions
- 11/27/24 - HC Wainwright
ICCM
Sec Filings
- 12/5/24 - Form 6-K
- 11/26/24 - Form 6-K
- 11/25/24 - Form 6-K
- ICCM's page on the SEC website