IceCure Medical (NASDAQ:ICCM) reported first-half 2026 revenue growth of approximately 45% as sales of its ProSense cryoablation systems and disposable probes increased, while management highlighted expansion of its U.S. commercial footprint and progress toward enrolling patients in its FDA-required post-market ChoICE study.
Revenue for the six months ended June 30 rose to $1.8 million from $1.25 million in the prior-year period, Chief Financial Officer Meir Peleg said during the company’s earnings call. Gross profit increased to $548,000 from $349,000, and gross margin improved to 30% from 28%.
U.S. Commercial Footprint Expands
IceCure said its active U.S. commercial installed base increased about 70% following the FDA clearance announced in October 2025. During the question-and-answer session, Shamir said the company now has more than 30 active commercial sites in the U.S.
Peleg said most system revenue comes from new system purchases rather than leases. Compared with the first half of 2025, the company sold roughly 20% to 25% more systems during the first half of 2026, while placements remained unchanged, he said.
Management also pointed to increasing disposable-probe utilization. Shamir said the percentage of disposable-probe sales remained broadly consistent year over year, with a modest increase in utilization. The company is adding sales personnel in key U.S. regions as it seeks to build its commercial organization and support additional physician adoption.
Regarding the second half, IceCure did not provide formal revenue guidance. A company representative said the third quarter is typically softer because of seasonal vacations, while the fourth quarter has historically been the company’s strongest quarter.
ChoICE Study Enrollment Expected in Weeks
IceCure described its FDA-approved ChoICE study as a post-market program that is intended to support both real-world evidence generation and commercialization. Participating sites purchase disposable probes as part of routine patient care while contributing clinical data, according to Shamir.
The company has signed contracts and received institutional review board approval at two clinical sites, with more than 10 additional sites in various stages of contracting, budget discussions and IRB review. Shamir said IceCure expects to enroll its first patient in the next three to four weeks and must enroll the first patient by Sept. 5.
Shamir also said the company believes it can enroll 80 patients by March 2027. He cited the experience of investigators including Dr. Richard Fine and Dr. Dennis Holmes as contributing to management’s confidence in meeting those targets.
Chief Operating Officer Shay Levav said sites using a central IRB may complete the approval process in roughly three to five weeks, while sites using their own IRB could require approximately four to seven weeks.
Margins Affected by Foreign Exchange, Expenses Rise
Peleg said first-half gross-margin expansion reflected increased revenue scale and improved operating leverage over fixed manufacturing and operating costs. However, he said foreign-exchange fluctuations partially offset those improvements. In response to an analyst question, Shamir said the impact of exchange-rate movements between the Israeli shekel and U.S. dollar was the main reason gross margin was not higher, with sales mix a smaller factor.
Research and development expense rose to $4.3 million from $3.4 million, primarily due to the initiation of the ChoICE study, continued clinical expansion and foreign-exchange effects on the company’s Israel-based cost structure. Sales and marketing expense increased to $2.5 million from $2 million, reflecting investments in the U.S. commercial organization and additional sales personnel.
General and administrative expenses were reported as ILS 2.4 million, compared with ILS 1.9 million a year earlier, driven by foreign-exchange effects on payroll-related expenses and higher non-cash share-based compensation. Net loss was ILS 8.8 million, or ILS 3.17 per share, compared with ILS 7 million, or ILS 3.59 per share, in the first half of 2025.
Financing and Reimbursement Efforts
Management said IceCure strengthened its balance sheet through financing activities during the first half, including approximately ILS 8.5 million in gross proceeds raised in the second quarter. Shamir said the company ended the period with approximately $12 million in cash and cash equivalents, while Peleg later referred to approximately ILS 12 million in cash and cash equivalents.
The company said it plans to use its financial resources to support commercial expansion, physician engagement, clinical evidence generation and reimbursement initiatives.
Asked about a potential CPT Category I reimbursement-code submission, Shamir said the company could not confirm or deny a submission because of American Medical Association confidentiality requirements. He said IceCure is progressing with its plan and noted that breast-cancer cryoablation appeared on the agenda for an AMA meeting expected in September, according to publicly available information referenced during the call.
Outside the U.S., Shamir said IceCure continues to engage physicians, medical societies and potential strategic partners in Japan as it advances longer-term commercialization efforts. The company also cited five-year results from its ICESECRET kidney cancer study, presentations at ECIO 2026, peer-reviewed publications and inclusion of ProSense in an American Society of Breast Surgeons resource guide as elements supporting its clinical and scientific strategy.
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.
