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IceCure Medical Reports Final ICE3 Breast Cancer Cryoablation Trial Results of 100% Patient and Physician Satisfaction and 96.3% Recurrence Free Rate: Data Submitted to FDA Requesting Marketing Authorization to Treat Early-Stage Breast Cancer
Data presentation at highly influential American Society of Breast Surgeons ("ASBrS") Annual Meeting by Dr. Richard Fine wins Scientific Impact Award as voted
About this update from Icecure Medical Ltd.
[{"type":"text","content":"Data presentation at highly influential American Society of Breast Surgeons (\"ASBrS\") Annual Meeting by Dr. Richard Fine wins Scientific Impact Award as voted by breast surgeons President-Elect of the ASBrS, Dr. Michael Berry, presents data and states \"cryoablation is ready for prime time\" Company seeks indication for treating women with early stage T1 invasive breast cancer with adjuvant hormone therapy Available reimbursement code for facility expense expected to enhance usage upon receiving marketing authorizationMinimally-invasive ProSense® cryoablation offers highly favorable healthcare economics CAESAREA, Israel, April 15, 2024 /PRNewswire/ -- IceCure Medical Ltd. (Nasdaq: ICCM) (\"IceCure\" or the \"Company\"), developer of the ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal, announced today that it has submitted final data to the U.S. Food and Drug Administration (\"FDA\") requesting marketing authorization for ProSense® for the indication of treating patients with early stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense®, which received the FDA's Breakthrough Designation, is already cleared for use in the U.S. for several other indications, including treating benign tumors of the breast, and tumors in the kidney and liver.\n\nThe Company provided the following requested data to the FDA:\nICE3 5-year follow up full data-set;sub-analysis of the ICE3 results compared with data from the \"LUMINA\" study (a study sponsored by Canada's Ontario Clinical Oncology Group, which evaluated the risk of recurrence in patients with low-risk Luminal A breast cancer who were treated with lumpectomy surgery and who had received adjuvant hormone therapy);analysis of the ICE3 data compared to an updated PRISMA meta-analysis; andreal-world data from the use of ProSense® globally, including post-market commercial use as well as data from independent third-party studies.The ICE3 study was the largest controlled multicenter clinical trial ever performed for liquid nitrogen (LN2) based cryoablation of low-risk, early-stage malignant breast tumors. The 5-year recurrence-free rates from this groundbreaking study, which evaluated IceCure's minimally invasive 20-to-40-minute outpatient cryoablation procedure, were in...