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Icecure Medical’s ProSense® Cryoablation Therapy Poised for FDA Clearance: A Buy Rating Analysis
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Icecure Medical’s ProSense® Cryoablation Therapy Poised for FDA Clearance: A Buy Rating Analysis

Icecure Medical (ICCMResearch Report), the Healthcare sector company, was revisited by a Wall Street analyst today. Analyst Yi Chen from H.C. Wainwright remains neutral on the stock and has a $3.00 price target.

Yi Chen’s Buy rating for Icecure Medical’s stock is based on a series of positive developments concerning the company’s De Novo application for its ProSense® cryoablation therapy. The recent decision by the FDA to reopen the application process is particularly noteworthy, as it may pave the way for the therapy to be cleared for use in a significant patient population. The analyst underscores the potential for ProSense to serve approximately 65,000 U.S. patients annually, which highlights the therapy’s market opportunity. The FDA’s request for IceCure to submit a comprehensive five-year dataset from its ICE3 study by April 2024, is seen as a positive step that could lead to clearance in the latter half of 2024. This timeline is notably ahead of the company’s previous expectations, indicating a potentially expedited regulatory process.

Additionally, the FDA’s invitation for IceCure to provide real-world global data where ProSense is already approved underscores the potential for a robust body of evidence supporting the therapy’s efficacy. The comparison of the ICE3 study results with data from the LUMINA study, which indicated low recurrence rates in a subset of breast cancer patients, provides a favorable benchmark for ProSense. Yi Chen believes that the LUMINA study results, published in a reputable medical journal, could serve as a solid reference point for the FDA when evaluating ProSense’s efficacy, further justifying the optimistic outlook for Icecure Medical’s stock.

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Icecure Medical (ICCM) Company Description:

Icecure Medical Ltd is a Israel based firm which develops and markets minimally invasive cryoablation therapies for women’s health. The company provides a minimally invasive, in-office definitive treatment for symptomatic breast fibroadenoma.

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