ICCM - IceCure gains 19% on seeking FDA nod for cancer treatment

• The shares of Israeli medical device maker IceCure Medical Ltd ( NASDAQ: ICCM ) added ~19% pre-market Wednesday after the company announced it submitted a regulatory filing to obtain FDA clearance for ProSense System to treat breast cancer.
• ProSense System is designed to destroy tumors through cryoablation (freezing). ICCM's De Novo Classification Request for the device is based on interim data from the ICE3 clinical trial targeted at low-risk breast cancer in patients who are at high risk of undergoing surgery.
• With the final ICE3 data readout expected in 1H 2024, ICCM expects to seek FDA clearance for ProSense, targeting a broader indication that covers the entire study population.
• "While we await the full study read out of the ICE3 trial, we believe that our first submission makes a strong case for approval based on our interim analyses of the ICE3 data, highly favorable patient outcomes, and improved healthcare economics," ICCM Chief Executive Eyal Shamir said.

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