IceCure Medical Ltd. has completed the five‑year follow‑up of its ICESECRET kidney‑cancer trial, the final step before the company releases the full analysis of ProSense’s performance in treating small renal masses.
The multicenter, single‑arm study enrolled 114 patients with 138 lesions measuring ≤5 cm, all treated with ProSense cryoablation under CT guidance at Bnai Zion Medical Center in Haifa and Shamir Medical Center in Be’er Ya’akov. Follow‑up visits occurred at six weeks, six months, one year and annually through five years, collecting data on local recurrence and procedure‑related adverse events. Interim three‑year data, presented a year earlier, showed an 88.7 % recurrence‑free rate among 111 eligible patients.
Eyal Shamir, IceCure’s CEO, said, "Interim three‑year data from ICESECRET, which was collected from 111 eligible patients at the time, was presented a year ago and demonstrated the strong potential of ProSense® cryoablation as a safe and effective option for patients who are otherwise ineligible for kidney preserving surgery, a growing unmet need." He added, "Importantly, ProSense® already has regulatory approval to treat kidney cancer in key markets including the U.S. and Europe."
The trial milestone comes as IceCure reports revenue challenges, with the nine months ending September 30 2025 showing a decline versus the prior year, although gross profit improved. The company posted a net loss for the same period and held approximately $8.9 million in cash and cash equivalents as of December 31 2025. IceCure is scheduled to report its Q4 2025 earnings on March 26 2026.
The final analysis of the five‑year data is expected in the second quarter of 2026 and will provide the most comprehensive evidence of ProSense’s long‑term durability and safety. A robust dataset will strengthen the evidence base that underpins the device’s FDA‑cleared use for kidney cancer and could support broader adoption in the U.S., Europe and other markets.
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