IceCure 9M Sales Growth 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

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].

On 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.

Near-Term Value Enhancing Catalysts

• The 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.

Conference call & webcast info:

Tuesday, November 26, 2024, at 10:00 am EST
US: 1-888-407-2553
Israel/International: +972-3-918-0696
A live webcast will be available at: https://Veidan.activetrail.biz/IcecureQ3-2024  
A recording of the webcast will be available at: ir.icecure-medical.com/

https://www.prnewswire.com/news-releases/icecure-medical-reports-36-sales-growth-in-the-first-nine-months-of-2024-driven-by-global-adoption-of-prosense-cryoablation-302316449.html