Medinice Completes CoolCryo Clinical Investigation and 6-Month Patient Follow-Up
April 29, 2026
Medinice S.A. announced the completion of the clinical investigation of the CoolCryo medical device. All participants completed the planned six-month follow-up period and remain in good health, while the collected data enables the company to move to the next stage of regulatory and commercialization activities.
The purpose of the study was to assess the safety profile and effectiveness of the CoolCryo technology in clinical conditions in patients undergoing a cryoablation procedure. The results obtained are in line with the company's expectations and confirm the assumed safety parameters of the device.
The completion of the clinical phase represents an important milestone in the development of the project. The collected data will be used in further work on technical documentation, clinical evaluation, and the certification process in accordance with the requirements of the MDR Regulation, including efforts to obtain CE marking for the European market.
“We are pleased to announce the completion of the CoolCryo clinical investigation and the six-month patient follow-up. Most importantly, all participants are doing well, which confirms the safety level of the device observed during the study. The results obtained provide the basis for further regulatory and commercialization activities” - said Sanjeev Choudhary, CEO of Medinice S.A.
CoolCryo is a cryoablation technology intended for the treatment of, among others, atrial fibrillation through cardiac surgical cryoablation. The system was developed by the Medinice scientific team under the leadership of Prof. Piotr Suwalski. In February 2026, the company obtained FDA clearance under the 510(k) pathway, enabling the device to be introduced to the U.S. market.
The completion of the clinical investigation strengthens CoolCryo's clinical base, reduces the project's development risk, and supports the company's ongoing commercialization activities.
About Medinice S.A.
Medinice S.A. is a medtech company listed on the Warsaw Stock Exchange, developing innovative medical technologies in the fields of cardiology and cardiac surgery. The company's business model is based on the identification, development, clinical and regulatory validation, and commercialization of medical projects with high market potential.
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