Regulatory Approval

IceCure asks Health Canada to widen ProSense cryoablation to older women

A Health Canada decision expected in H2 2026 would extend the FDA-cleared cryoablation device to a broader population, three years after FDA denied the same claim on the same trial data.

By AppliedXLJuly 13, 2026Trial NCT02200705

Executive Summary

IceCure is asking Health Canada to broaden its existing ProSense cryoablation approval to a population it has already tried, and failed, to win from the FDA on the first attempt.
The FDA's own path on this same trial data ran through a denial before it reached a narrower clearance, so the dataset's regulatory track record is mixed rather than a clean green light.
ProSense already carries FDA marketing clearance for low-risk breast cancer cryoablation, giving the Canadian filing a domestic precedent to point to even where the specific age-based population differs.
A Health Canada clearance would expand the commercial population for a device already generating sales, while a rejection or narrowed label would echo the FDA's earlier finding that this data did not support the broader claim.

The filing

IceCure submitted a Class III amendment application to Health Canada on March 16, 2026, seeking to add early-stage, low-risk invasive breast cancer in patients 60 and older to its existing ProSense cryoablation approval in Canada. The company says the filing rests on data from its ICE3 study, which it describes as the largest study of its kind and the same dataset that underpinned the FDA's eventual marketing clearance for ProSense in low-risk breast cancer. IceCure states that up to 7,130 women in Canada would become eligible for breast cancer cryoablation under the proposed label. Health Canada's decision is expected during the second half of 2026, subject to the agency's standard review procedures and any follow-up questions. IceCure

The trial behind the filing

ICE3, registered as NCT02200705, enrolled 208 patients in a single-arm, open-label design testing cryoablation in women 50 and older with unifocal, hormone-receptor-positive, HER2-negative invasive ductal carcinoma no larger than 1.5 centimeters. The trial's primary completion date moved three times in the registry, from December 2023 to August 2024 in April 2022, then to March 2024 in February 2024, before the trial completed in May 2024. Enrollment grew from 200 to 208 patients in February 2023, then settled at 206 after results posted in April 2025. Its primary endpoint, local in-breast tumor recurrence, was reported through up to five years of follow-up, alongside secondary measures covering complete tumor ablation, disease-free survival, overall survival, and cosmetic outcome satisfaction. NCT02200705

A mixed regulatory record on this data

The same ICE3 dataset has already run a full cycle through the FDA. IceCure filed a De Novo classification request for ProSense in low-risk breast cancer in October 2022, and the FDA denied that request in September 2023 based on interim ICE3 data. IceCure appealed the decision the following month, focused on the comparator group used in the review. The FDA ultimately cleared ProSense for low-risk breast cancer cryoablation in October 2025, two years after the initial denial. That sequence, a denial followed by an eventual clearance on the same trial, is the closest precedent for how a regulator can read this dataset, and it did not go smoothly the first time. IceCure

Commercial backdrop

IceCure reported record quarterly and annual sales of $1.3 million and $3.4 million for 2025, and pointed to the American Society of Breast Surgeons' updated 2026 resource guide recommending cryoablation as an option for selected low-risk breast cancer patients. The FDA separately approved the design of a post-marketing study, called ChoICE, expected to enroll 400 patients across 30 U.S. sites over 36 months, with enrollment beginning in the second half of 2026. Chief Executive Officer Eyal Shamir called the FDA clearance and the society's guidance signals of "powerful validation" for the technology. None of these developments bear on the Health Canada decision directly, but they establish that the device already has a commercial and regulatory footing outside the pending Canadian review. IceCure

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.