Business
IceCure Medical Reports 20% Growth in ProSense® System and Probe Sales for the First Half of 2024; Reflects Continued Adoption in the U.S. and Other Global Markets
Near-term regulatory and operating catalysts have potential to accelerate adoption of ProSense® for treatment of early-stage, low risk breast cancer
About this update from Icecure Medical Ltd.
[{"type":"text","content":"Near-term regulatory and operating catalysts have potential to accelerate adoption of ProSense® for treatment of early-stage, low risk breast cancer\nConference call to be held today at 10:00 am Eastern Time\nCAESAREA, Israel, Aug. 20, 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, today reported financial results as of and for the six months ended June 30, 2024.\n\nSignificant Near and Short Term Value Enhancing Catalysts\nU.S. Food and Drug Administration (\"FDA\") Medical Device Advisory Committee expected Q4 2024. The purpose of the meeting is to obtain independent expert advice on scientific, technical, and policy matters related to the Company's De Novo Marketing Clearance Request for a minimally invasive alternative treatment for women diagnosed with early-stage, low risk breast cancer.The FDA will review and evaluate the recommendation of the Medical Device Advisory Committee and is expected to have a final decision regarding marketing clearance of ProSense® in early-stage, low risk breast cancer by early 2025.Data from interim results of the Company's ICESECRET, a prospective, multicenter, single-arm clinical trial of ProSense® in the treatment of kidney cancer, is expected to be presented by December 2024.The Company's partner in Japan, Terumo Corporation, is expected to file for regulatory approval of ProSense® for early-stage low risk breast cancer with endocrine therapy in Japan in the first quarter of 2025, with the aim of receiving clearance and making the Company's cryoablation system more commercially available to physicians and patients alike in Japan.With 15 ongoing independent studies being performed globally, the Company expects additional third-party data on ProSense® will be published in medical journals and presented at prestigious medical conferences.\"We have achieved all of our primary objectives for the first half of 2024, and we are now in the process of preparing for the FDA Medical Device Advisory Committee, which we expect to be scheduled for Q4,\" stated IceCure Medical's CEO, Eyal Shamir. \"The data from the ICE3 study has been overwhelmingly positive, and with a reported 100% patient and physician s...