Core Insights - The FDA granted marketing authorization for IceCure's ProSense® cryoablation system for local treatment of low-risk breast cancer in patients aged 70 and above, marking a significant milestone for the company and its technology [2][3][5] - The U.S. market for ProSense® is expected to expand significantly, with an estimated 200,000 patients eligible for treatment, including those not suitable for surgery and those with benign tumors [3][6] - The company anticipates increased demand for ProSense® systems, with installations expected to rise in 2026 following the FDA's approval [1][6] Regulatory Developments - ProSense® received FDA marketing authorization for treating low-risk breast cancer in women aged 70 and older, which is expected to open the U.S. market for IceCure's technology [2][7] - The company has also received regulatory approval in Switzerland for various indications, including breast cancer, which will facilitate commercial sales [8][6] Financial Performance - For the nine months ended September 30, 2025, IceCure reported revenues of $2.1 million, a decrease from $2.416 million in the same period in 2024 [8][10] - Gross profit for the same period was $626,000, with a gross margin of 30%, down from 43% in the previous year [10][12] - The net loss for the nine months ended September 30, 2025, was $10.811 million, or $0.18 per share, relatively unchanged from a net loss of $10.839 million, or $0.22 per share, in the prior year [14][10] Operational Highlights - The company plans to roll out ProSense® to 30 clinical and commercial sites across the U.S., pending FDA review of its post-market study protocol [6][5] - IceCure's U.S. sales team is actively working to increase installations and procedure volumes, with positive commercial traction expected [3][6] - The company has conducted multiple independent clinical studies validating the efficacy of ProSense®, with high rates of patient satisfaction and low recurrence rates reported [8][12] Upcoming Catalysts - Regulatory submission for ProSense® in Japan is expected in the first half of 2026, which could further expand the market for IceCure's technology [6][8] - The company anticipates potential reimbursement coverage for ProSense® procedures, which may increase following the FDA's marketing authorization [6][8]

Core Insights - IceCure Medical Ltd. has received FDA marketing authorization for its ProSense® cryoablation system, marking a significant advancement in breast cancer treatment [1] - The ProSense® system offers a minimally invasive outpatient procedure as an alternative to traditional lumpectomy [1] - Initial reimbursement under the CPT III code covers $3,800 of facility costs, with expectations for additional reimbursement coverage [1] Company Developments - The ProSense® system is specifically authorized for local treatment of breast cancer in patients aged 70 years with biologically low-risk tumors measuring 1.5 cm, who are treated with adjuvant endocrine therapy [1] - This authorization represents a potential market of approximately 46,000 women annually in the U.S. who may benefit from this treatment option [1] - The U.S. sales and distribution team is prepared to promote ProSense® systems and disposable probes, aiming to support both the medical community and patients [1] Industry Impact - The response from leading U.S. breast surgeons and radiologists has been enthusiastic, indicating strong interest in the new treatment option [1] - A conference call is scheduled for October 6 at 8:30 AM Eastern Time to discuss further details regarding the ProSense® system [1]