H.C. Wainwright has maintained a Buy rating on IceCure Medical Ltd. (NASDAQ: ICCM), with a price target of $2.50. This endorsement follows IceCure Medical's announcement on Thursday that a U.S.
FDA medical device advisory committee panel meeting is scheduled for November 7, 2024. The panel is expected to review the De Novo application for the company's ProSense system, which is designed for the treatment of patients with early-stage low-risk invasive breast cancer using cryoablation and adjuvant endocrine therapy.
The advisory committee will consist of breast surgeons, interventional radiologists, and industry representatives from the regulatory community who will provide independent expert advice on various aspects of the application.
A positive recommendation from the panel could lead to FDA marketing clearance for ProSense as early as 2025. ProSense represents a minimally invasive alternative to lumpectomy, potentially benefiting approximately 70,000 women in the U.S. diagnosed annually with early-stage low-risk breast cancer.
Additionally, IceCure Medical's partner in Japan, Terumo (unrated by H.C. Wainwright), is planning to seek regulatory approval for ProSense in Japan for the same indication in the first quarter of 2025. The ongoing developments and planned regulatory submissions underscore IceCure Medical's efforts to expand the availability of ProSense to key markets.
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