IceCure Medical (NASDAQ:ICCM) reported a stronger start to 2026, with management saying first-quarter revenue rose 26% year over year as the company saw increased commercial activity for its ProSense cryoablation system following U.S. Food and Drug Administration clearance for low-risk early breast cancer.
Chief Executive Officer Eyal Shamir said North American sales increased 84% in the quarter, while U.S. sales grew 31%, driven by new system placements and higher sales of disposable probes. He said the probe sales reflect rising procedure volume at both new and existing customer sites.
U.S. commercial footprint expands after FDA clearance
Shamir said IceCure had 13 active accounts before FDA approval, including some with multiple systems installed. Since the clearance, the company has added new accounts and reactivated others that had been inactive while awaiting FDA clearance, increasing its active account base to 19. That represents a 46% increase compared with the number of active accounts before the FDA decision, he said.
Management said it expects continued growth in active accounts during the second quarter, based on currently available information. Shamir said the company is seeing engagement from a range of customer types, including large hospital networks, regional hospital networks and outpatient clinics. He emphasized that ProSense can be integrated into existing workflows without additional infrastructure or complex integration.
While the United States remains IceCure’s main commercial focus, Shamir said the FDA clearance has also increased global interest in ProSense across Europe, Asia and the Americas. He noted that although ProSense already had CE mark approval in Europe for breast cancer, the FDA clearance has had a “visible impact” on physician interest internationally.
Conference activity generates higher lead volume
Shad Good, IceCure’s vice president of sales for North America, said demand for ProSense in the U.S. has accelerated meaningfully. At the Society of Breast Imaging and American Society of Breast Surgeons annual conferences, the company was able to directly market ProSense for breast cancer treatment for the first time following FDA clearance.
Good said the number of qualified leads generated at those conferences was significantly higher than the company experienced in 2025 before clearance. He attributed the stronger interest to FDA clearance, independent clinical data, updated American Society of Breast Surgeons guidelines recommending cryoablation for low-risk breast cancer, and an expanding reimbursement framework.
“The leads generated following FDA clearance are now progressing through purchasing processes and are expected to convert into system sales and installations this quarter and over the following quarters,” Good said.
He added that IceCure is expanding its U.S. commercial organization by hiring additional sales representatives to increase its sales footprint.
ChoICE post-market study moves forward
Good also discussed IceCure’s ChoICE post-market study, which received FDA approval during the first quarter. The study is expected to include 30 clinical and commercial hybrid sites across the U.S. Good said IceCure expects to announce sites as they onboard and said the study could support adoption by expanding access to ProSense while generating additional clinical data and aiding reimbursement efforts.
During the question-and-answer session, management said about half of IceCure’s current active sites are planning to participate in the ChoICE study. Shamir said the company believes it remains on schedule, with plans to have the first patient before Sept. 5 and to complete 80 patients before March 27.
Asked what the ChoICE study could show, Dr. Richard Fine, a breast surgeon, ICE3 investigator and key opinion leader in breast cancer treatment, said he expects it to reconfirm results from the ICE3 trial. He said the FDA approved “a pretty favorable group of patients” for the post-market study and that he expects strong results that could help support broader indications in the future.
Reimbursement and physician adoption remain key topics
Good said procedures performed with ProSense are already supported by an established CPT code covering facility costs of about $4,000. He said the company expects to submit for a CPT 1 code to cover physician costs in June, with feedback expected in early 2027. If approved, the code could result in additional reimbursement by early 2028. IceCure also applied for transitional pass-through payment, which Good said may result in an additional $900 by early 2027 if the company qualifies.
In response to an analyst question, Shamir said the CPT 1 submission package is being finalized and is expected to be filed in two to four weeks. He said the company expects the code to be approved during 2027 and become effective Jan. 1, 2028.
Fine said that while awaiting broader physician reimbursement, some facilities are using an office-based approach for commercial patients. He said patients have been willing to pay out of pocket when the procedure is explained to them, adding that he had not yet had a patient decline for that reason.
Clinical perspective and international regulatory updates
Fine said that as an ICE3 investigator, he has treated patients using ProSense and followed their outcomes over time. He said he is now able to recommend the minimally invasive option to appropriate patients, specifically women with low-risk breast cancer who are 70 years or older, as well as patients who may not be suitable candidates for surgery.
Fine said physicians at medical conferences have shown high interest in cryoablation, with surgeons and radiologists seeking information and hands-on training. He also pointed to a high level of investigator-initiated research using ProSense and the 2026 American Society of Breast Surgeons resource guide, which recommends cryoablation as an option for selected patients with biologically low-risk breast cancer.
In the Q&A session, Shamir said IceCure continues to expect a Health Canada decision before the end of the year after submitting an amendment in March and responding to technical and informal questions. Regarding Japan, he said partner Terumo had positive discussions with Japan’s PMDA in January and is moving “full speed” toward submission, though he said it may occur by the end of June or in early third quarter.
Shamir also said IceCure’s U.S. efforts will remain focused on breast cancer, while the company continues treating other organs in Europe and Asia. He referenced lung cancer data published in November and said other organ treatments are being conducted outside the U.S.
Closing the call, Shamir said the first quarter marked “an important step forward” for IceCure, with clinical data, regulatory milestones and physician engagement translating into commercial growth, particularly in the United States.
About IceCure Medical (NASDAQ:ICCM)
IceCure Medical Ltd. (NASDAQ: ICCM) is a clinical-stage medical device company specializing in the development and commercialization of proprietary cryoablation systems for the treatment of tumors and other pathological tissues. The company’s core technology employs a unique liquid-nitrogen-based platform to deliver rapid cooling through fine-gauge cryoprobes, enabling precise and minimally invasive tissue ablation under imaging guidance. IceCure’s lead product, ProSense, is designed to offer a single-probe approach that can be deployed in an outpatient setting, reducing procedure time and patient recovery periods.
Originally founded in Israel, IceCure Medical obtained its first CE mark for the treatment of benign breast tumors and fibroadenomas in 2017.
