A 400-patient postmarket study will track whether image-guided cryoablation holds up outside a single-arm trial for older women with small, low-risk tumors.
What Happened
IceCure Medical has enrolled the first two patients in ChoICE (NCT07629206), a U.S. postmarket study of its ProSense cryoablation system for low-risk breast cancer [1][2]. The study plans to enroll about 400 patients at up to 30 U.S. sites [1]. The first patients were enrolled at West Cancer Center & Research Institute in Germantown, Tennessee, and Adventist Health Glendale in California [1]. IceCure announced the milestone on October 20, and Endovascular Today reported it on October 26 [1][2].
The study design matches what the FDA required. When the agency authorized ProSense, it ordered a postmarket study of about 400 patients at 30 sites. The co-primary endpoints are confirmed ipsilateral breast tumor recurrence (cancer returning in the same breast) and confirmed-plus-suspected recurrence through five years [3]. IceCure calls ChoICE its "FDA-Approved Study" [2].
Background
ProSense treats a tumor by freezing it rather than removing it. Under ultrasound guidance, a 10-gauge probe is inserted through a small skin incision into the tumor's center. Liquid nitrogen then builds an ice ball around it in two freeze cycles separated by a thaw [6]. The procedure uses local anesthesia and can be done in an office, with same-day discharge [6]. Breast cancer treatment has long been a matter of cutting; this is a bet on cold.
The FDA granted ProSense a De Novo marketing authorization (Class II) in October 2025 [3]. The authorization covers patients 70 or older with biologically low-risk tumors 1.5 cm or smaller who also receive endocrine therapy, including patients not suited for surgery [3]. The path was not smooth. The FDA denied IceCure's De Novo request in 2022 and agreed to reopen it in January 2024 [8]. In November 2024, an FDA advisory panel voted 9 to 5 that the device's benefits outweigh its risks [4].
What the Evidence Shows
The authorization rests largely on ICE3, a single-arm, nonrandomized study at 19 U.S. sites [6]. ICE3 treated 206 women and analyzed 194 for efficacy, with a mean age of 74.9 [6]. Mean follow-up was about 54 months [6]. The authors reported a five-year Kaplan-Meier recurrence rate of 4.3% (95% CI, 2.1%-8.7%) [6]. There were no serious device-related adverse events. The most common side effects were bruising, pain at the needle site and swelling [6]. IceCure funded the trial, and several authors reported financial ties to the company [6].
The FDA's own analysis was less rosy. Using a different statistical method, agency reviewers estimated five-year recurrence at 6.2% in the primary analysis group and 8.7% in all treated patients [5]. For the narrower group that matches today's label, the FDA estimate was 2.3% [5]. Only 131 of 206 patients completed the 60-month visit [5].
Limitations and Open Questions
ICE3 had no comparison arm, so it cannot show how cryoablation stacks up against lumpectomy. Panel members called for randomized trials and data beyond five years [4]. They also noted that mammography and ultrasound typically underestimate tumor size by 2 to 3 mm [4]. The FDA requires the device's labeling to describe these data limitations and the lack of direct comparison with surgery [3].
According to the Association of Health Care Journalists, panel consumer representative Cindy Pearson said women deserve to know the procedure "is not as well-proven as lumpectomy" [7]. ChoICE will produce larger real-world numbers, but it is still not a randomized comparison.
Why It Matters for Interventional Radiology
Image-guided ablation of small tumors sits at the crossroads of surgery and interventional radiology. The FDA advisory panel included both breast surgeons and interventional radiologists [9]. IceCure's announcements of ChoICE sites so far name breast surgeons as the local investigators [10][11]. Who ends up performing the procedure in routine practice is one more thing to watch.
What Comes Next
Under the FDA order, IceCure must enroll all patients within 36 months of protocol approval and submit regular progress reports [3]. Final recurrence results will take at least five years of follow-up [3].
This article is for informational purposes only. Readers should consult their clinician about any health concerns.
References
Endovascular Today. "IceCure Begins Postmarket Study of ProSense Cryoablation for Breast Cancer." October 26, 2026. https://evtoday.com/news/icecure-begins-postmarket-study-of-prosense-cryoablation-for-breast-cancer
IceCure Medical. "IceCure Enrolls First Patients in Its FDA-Approved Study for ProSense Breast Cancer Cryoablation at Two U.S. Sites." PR Newswire. October 20, 2026. https://www.prnewswire.com/il/news-releases/icecure-enrolls-first-patients-in-its-fda-approved-study-for-prosense-breast-cancer-cryoablation-at-two-us-sites-302913757.html
U.S. Food and Drug Administration. De Novo classification order, DEN220077 (ProSense Cryoablation System), October 3, 2025; corrected March 20, 2026. https://www.accessdata.fda.gov/cdrh_docs/pdf22/DEN220077.pdf
U.S. Food and Drug Administration. General and Plastic Surgery Devices Panel meeting summary, November 7, 2024. https://fda.gov/media/184077/download
U.S. Food and Drug Administration. Panel briefing document, discussion questions, November 7, 2024. https://www.fda.gov/media/183318/download
Fine RE, Gilmore RC, Tomkovich KR, et al. "Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence." Annals of Surgical Oncology. 2024;31(11):7273-7283. doi:10.1245/s10434-024-16181-0. https://link.springer.com/article/10.1245/s10434-024-16181-0
Jaklevic MC. "Let's cool the hype about 'ice' treatment for breast cancer." Association of Health Care Journalists. January 20, 2025. https://healthjournalism.org/blog/2025/01/lets-cool-the-hype-about-ice-treatment-for-breast-cancer/
Whooley S. "FDA approves IceCure cryoablation for breast cancer." MassDevice. October 3, 2025. https://www.massdevice.com/fda-approves-icecure-cryoablation-breast-cancer/
Endovascular Today. "IceCure's ProSense cryoablation system's benefit-risk profile for breast cancer indications reviewed by FDA panel." November 25, 2024. https://evtoday.com/news/icecures-prosense-cryoablation-systems-benefit-risk-profile-for-breast-cancer-indications-reviewed-by-fda-panel
IceCure Medical. "IceCure Medical Kicks Off its Post-Marketing 'ChoICE' Study for the Low-Risk Breast Cancer Treatment at First U.S. Clinical Site." July 27, 2026. https://ir.icecure-medical.com/news-events/press-releases/detail/230/icecure-medical-kicks-off-its-post-marketing-choice-study-for-the-low-risk-breast-cancer-treatment-at-first-u-s-clinical-site
IceCure Medical. "IceCure Medical Adds Adventist Health as U.S. Clinical Site for Its Post-Marketing ChoICE Study." August 6, 2026. https://ir.icecure-medical.com/news-events/press-releases/detail/233/icecure-medical-adds-adventist-health-as-u-s-clinical-site-for-its-post-marketing-choice-study-for-low-risk-breast-cancer-cryoablation-treatment
