IceCure Medical Ltd. is expecting to report record fourth quarter sales in North America, driven by rising demand for its ProSense® Cryoablation System following recent regulatory clearance in the United States.
The Caesarea-based medical device company said preliminary information indicates a significant year-on-year increase in regional sales for the final quarter of 2025. If confirmed, the results would mark the highest quarterly sales levels achieved by the company in North America to date.
The anticipated growth follows the U.S. Food and Drug Administration’s marketing authorisation in October 2025 for ProSense® to be used in the local treatment of low-risk breast cancer in women aged 70 and above. Since then, ProSense® systems have been sold and installed at new sites across North America, including several leading medical institutions in the United States.
IceCure develops minimally invasive cryoablation technology that destroys tumours by freezing, offering an alternative to surgical tumour removal. The company said interest in both the ProSense® console and its disposable cryoprobes has increased steadily since the FDA decision.
Eyal Shamir, Chief Executive Officer of IceCure, said demand had accelerated quickly following regulatory clearance. “We are highly encouraged by the strong and rapid interest from doctors and medical institutions just two months after the FDA’s marketing authorization for ProSense® in low-risk breast cancer,” he said. “We believe several factors correlated with the FDA’s recent favorable decision are driving demand, such as ProSense®’s high visibility at medical conferences including hands-on training sessions, our engagement with breast-focused medical societies, the growing body of independent studies and peer reviewed data, and patient-driven demand supported by increasing media coverage and awareness of our non-surgical option.”
Shad Good, Vice President of Sales North America, said hospitals and clinicians across the country are now actively evaluating the technology. “Our sales team is engaged with a growing number of hospitals, clinics, breast surgeons and radiologists nationwide who are evaluating ProSense® and placing orders,” he said. “As expected, the FDA’s marketing authorization is a major catalyst in the growth of our sales pipeline.”
Good added that one of the most recent orders came from a hospital network ranked among the world’s leading healthcare providers, with multiple locations across the US, which the company believes could influence wider market adoption.
IceCure said it plans to release preliminary top-line revenue results in January 2026, followed by its full annual report on Form 20-F in April 2026. ProSense® has also been featured in a growing number of mainstream media outlets and healthcare publications, contributing to increased awareness among patients and providers.
About ProSense®
The ProSense® Cryoablation System is the first and only medical device to receive FDA marketing authorization for the local treatment of low-risk breast cancer with adjuvant endocrine therapy for women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. A full list of benefits and risks can be found on the Company’s website.
ProSense® is a minimally invasive cryosurgical tool that provides the option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including in the breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens the door to fast and convenient office-based procedures for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective option to surgical tumor removal that is easily performed in a relatively short procedure. The Company’s flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the U.S., Europe, and Asia.
