IceCure Medical (NASDAQ:ICCM) reported record sales for the fourth quarter and full year 2025 and outlined a commercialization strategy centered on its ProSense cryoablation system following recent regulatory and guideline milestones in the U.S. Management highlighted growing interest from hospitals and clinics, progress toward a required U.S. post-marketing study, and ongoing efforts to expand reimbursement and international indications.
Record 2025 revenue and a fourth-quarter sales high
CEO Eyal Shamir said the company delivered record fourth-quarter sales of approximately $1.3 million, contributing to record full-year 2025 revenue from sales of $3.4 million. Shamir attributed the growth to record unit sales, which he said reflected the positive impact of the U.S. FDA clearance for use in low-risk early-stage breast cancer and continued adoption of ProSense in key markets.
FDA clearance and new U.S. guideline recommendation highlighted as catalysts
Shamir emphasized the October 2025 FDA clearance of ProSense for treatment of low-risk breast cancer in women aged 70 and older, as well as patients not suitable for surgery. He also pointed to a recent guideline development from the American Society of Breast Surgeons (ASBrS), which now recommends cryoablation as an option for selected patients with biologically low-risk early-stage breast cancer.
According to Shamir, the ASBrS statement represents a notable catalyst for adoption by supporting patient and physician decision-making and potentially supporting reimbursement expansion. He also said ProSense is the first and only FDA-cleared medical device for treatment of breast cancer.
Shamir argued that the FDA marketing authorization raises the bar for potential competitors seeking to market cryoablation systems for breast cancer via the 510(k) pathway, saying other companies would be required to submit full filings with clinical follow-up data.
Commercial pipeline, installations, and expanding U.S. sales capacity
Management described continued progress converting a growing pipeline into signed contracts, delivery, and installation. Shamir cited previously announced customers, including Shero Imaging and Thomas Hospital, and added that other hospitals are increasing ProSense installations and procedures, including one described as a large university hospital in the Southeast and another “among the world’s most highly regarded medical institutions,” which now has systems at two of its largest facilities. He said the company believes there is an opportunity to install additional systems through that hospital network, though it could not name the institutions.
Shamir also noted that the last two customer announcements were “purely commercially focused” and not part of the post-marketing study process. He described a “flywheel effect” where each new installation may increase awareness and demand. As one example, he referenced a local Alabama news segment tied to the Thomas Hospital installation, in which a physician described performing cryoablation on a 90-year-old breast cancer patient in 30 minutes.
Investor relations representative Michael Polyviou, reading prepared remarks and adding context, said three factors had converged to accelerate adoption in the U.S.:
- ProSense is FDA cleared.
- There is established reimbursement.
- The ASBrS issued new guidelines recommending cryoablation for low-risk breast cancer.
Polyviou said the company is seeing increased engagement from patients and facilities. Based on activity in the fourth quarter of 2025 and the first quarter of 2026, he said IceCure believes it will close an increasing number of system sales and installations during the second quarter, with continued growth in subsequent quarters of 2026.
He also said IceCure plans to expand its U.S. commercial organization, stating that by the end of 2026 the company intends to triple its commercial team to align with demand and pursue broader U.S. penetration. Polyviou described ProSense as easy to implement for customers already performing ultrasound and needle biopsies, and said the system does not require access to hospital IT systems or additional infrastructure investment. He characterized sales cycles as ranging from a few months to nine months depending on the size of the customer.
Shamir added that interest is rising among both breast radiologists and surgeons, with the customer pipeline split about evenly between the two specialties. The company also plans to attend the Society of Breast Imaging Symposium and the ASBrS annual meeting in April, noting it will be the first time it can promote ProSense for breast cancer.
Post-marketing study timeline and reimbursement initiatives
A key element of IceCure’s U.S. plan is an FDA-required post-marketing study (PMS). Polyviou said the FDA is requiring 30 sites and that the majority have been identified. He said IceCure expects to begin onboarding in the next three to six months, with all 30 sites open by the end of next year. Patient enrollment is slated to begin in late summer, with 20% enrollment expected by this time next year. Polyviou added that the PMS sites will commit to performing commercial procedures outside of the study patients and that PMS procedures are eligible for reimbursement.
During Q&A, COO Shay Levav provided additional detail, saying the company has identified the sites but is still in the process of signing agreements and completing requirements with the help of a contract research organization (CRO).
On reimbursement, Levav said IceCure currently operates under a CPT Category III code, with payment of about $4,000, and that reimbursement has become more consistent following FDA approval. He said the company has a payer outreach program focused on private payers, with emphasis on Medicare Advantage because of the FDA labeling population.
Polyviou said IceCure has applied for transitional pass-through payment, which could add up to $900 per procedure by early 2027. He also said the company expects to submit for CPT Category I reimbursement covering physician costs in the second quarter of 2026, with a response anticipated by early 2027 and a potential effective date in early 2028. Levav told analysts the company views CPT Category I as part of establishing standard of care and described early 2028 as a potential “inflection point” for faster growth.
International activity: Canada filing and Japan update
Shamir said the company’s view that U.S. FDA clearance would boost demand in other markets where ProSense is already approved for breast cancer is being borne out, particularly in Europe.
He also announced that IceCure submitted a Class III amended application to Health Canada to expand its current approval to include early-stage, low-risk invasive breast cancer in patients aged 60 and older, supported by ICE3 data and the U.S. FDA clearance. Shamir said the company expects a decision in the second half of 2026, subject to standard review and potential follow-up questions. During Q&A, Levav said the submitted indication (60 and above) represents a little more than 10,000 new cases annually in Canada.
On Japan, Levav said IceCure is working with Terumo and that, following the FDA clearance, Terumo has begun the PMDA process. He said Terumo has had a first general consultation with positive outcomes and comments to address, with another discussion planned before moving to formal submission.
In closing remarks, Shamir said the company is at a “turning point,” citing FDA clearance and the medical society recommendation as drivers of a growing commercial pipeline and stating the company expects to convert potential customers into “thousands of installations.”
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.
