Business
IceCure Medical Reports 36% Sales Growth in the First Nine Months of 2024 Driven by Global Adoption of ProSense® Cryoablation
FDA Marketing Authorization Decision on Early Stage-Low Risk Breast Cancer Expected in Q1 2025 Conference call to be held today at 10:00 am Eastern Time
About this update from Icecure Medical Ltd.
[{"type":"text","content":"FDA Marketing Authorization Decision on Early Stage-Low Risk Breast Cancer Expected in Q1 2025\nConference call to be held today at 10:00 am Eastern Time\nCAESAREA, Israel, Nov. 26, 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 nine months ended September 30, 2024. Sales of ProSense® consoles and disposable probes increased by 36%. Gross profits increased by 41%, while non-GAAP gross profits grew by 104%. Gross margins increased to 43%, while non-GAAP gross margin increased to 40%, compared to 27% in the same period in 2023].\n\nOn November 7, 2024, the U.S. Food and Drug Administration's (\"FDA\") Medical Device Advisory Committee Panel (the \"Advisory Panel\") voted in favor of ProSense®'s benefit-risk profile in early-stage low risk breast cancer.\nNear-Term Value Enhancing Catalysts\nThe FDA will review and evaluate the Advisory Panel's recommendation and is expected to make a final decision regarding marketing authorization of ProSense® in early-stage, low risk breast cancer with endocrine therapy in the first quarter of 2025.Interim results of the Company's ICESECRET, a prospective, multicenter, single-arm clinical trial of ProSense® for the cryoablation of kidney cancer, are expected to be released in December 2024.Terumo Corporation, IceCure's partner in Japan, is expected to file for regulatory approval of ProSense® for breast cancer in Japan in 2025, with the aim of receiving regulatory clearance.The Company expects that additional third-party data on ProSense® will be published in medical journals and presented at prestigious medical conferences throughout 2025.\"While our efforts have remained focused on the U.S. marketing authorization for ProSense® in early-stage breast cancer, the impressive 36% sales growth for the first nine months ended September 30, 2024, compared to the same period last year, demonstrates our commitment to working with our global partners to accelerate the adoption and increase the utilization of ProSense®,\" stated IceCure Medical's CEO, Eyal Shamir. \"As we near the end of 2024, it goes without saying that it is shaping up to be a transformativ...