The U.S. Food and Drug Administration approved the design of IceCure Medical’s post‑market “ChoICE” study for its ProSense cryoablation system on March 11 2026, a regulatory milestone that allows the company to collect real‑world data on the device’s performance in low‑risk breast cancer patients.
The study will enroll roughly 400 patients across 30 U.S. clinical sites over a 36‑month period, with the first cohort expected to begin in the second half of 2026. The design also requires that participating sites treat enrolled patients while continuing to offer ProSense to non‑study patients, thereby expanding commercial access to the device during the study period.
ProSense received FDA clearance in October 2025 for women 70 years and older with biologically low‑risk tumors (≤1.5 cm) treated with adjuvant endocrine therapy. The device is supported by a CPT Category III reimbursement code that provides a $4,000 facility fee, which can help offset costs for both patients and providers during the study and beyond.
IceCure’s financial picture remains challenging. Trailing‑12‑month sales total $2.98 million, and the company reports a negative gross margin of 35 %, a negative operating margin of 517 %, and a negative net margin of 514 %. Earnings per share for the most recent period were –$0.25. The company has raised $10 million through a rights offering and $5.87 million through a market offering, leaving a cash balance of $11.8 million as of October 31 2025.
The study’s real‑world data will support broader adoption of ProSense and could inform future regulatory submissions or expanded indications. By allowing sites to treat both study and non‑study patients, the design accelerates market penetration and may strengthen reimbursement arguments as more clinicians gain experience with the device.
IceCure is scheduled to report its full‑year 2025 results on March 17 2026. The upcoming earnings release will provide a clearer view of the company’s financial health and the impact of the study on its commercial strategy.
In summary, the FDA’s approval of the ChoICE study design is a significant regulatory event that could enhance ProSense’s market position, but the company’s limited revenue base and negative margins underscore the need for continued financial discipline and successful commercialization to achieve long‑term viability.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.