Medinice S.A., a GPW-listed medtech company, has announced the completion of the clinical trial of its CoolCryo technology, an innovative solution developed for use in cardiac surgery procedures. All participants completed the planned six-month follow-up period and remain in good health.
The study was designed to assess the safety profile and effectiveness of CoolCryo under clinical conditions in patients undergoing cryoablation procedures. The results obtained so far provide an important basis for the next stages of the project, including regulatory activities, commercialization efforts and talks with potential partners.
The collected clinical data will form a key part of the documentation prepared for conformity assessment under MDR requirements and for obtaining CE marking in the European market. The company will also use the trial results in technical documentation, clinical evaluation and communication with the notified body.
According to Medinice, the results are in line with the company’s expectations and confirm the assumed safety parameters of CoolCryo. Completion of the clinical phase marks an important milestone in the development of the project and confirms its readiness for the next regulatory and commercialization stages.
“We are very pleased to announce the completion of the CoolCryo clinical trial and the six-month patient follow-up. Most importantly, all participants are doing well, which confirms the level of device safety demonstrated during the study. This is an important stage in the development of Medinice S.A., whose goal is to develop technologies that genuinely support physicians and improve patient care,” said Sanjeev Choudhary, CEO of Medinice S.A.
“The results obtained provide a basis for further regulatory and commercialization activities. As we previously announced, this product already has FDA clearance, and the completion of the clinical trial brings us closer to obtaining CE certification,” he added.
The completion of the clinical trial confirms the completeness of the collected data and allows the company to move to the next stage of work on the project. This includes detailed analysis of clinical results, preparation of technical documentation and clinical evaluation required for the MDR certification process, one of the two regulatory pathways for the product.
In February 2026, the company received 510(k) clearance from the U.S. Food and Drug Administration, allowing the device to be introduced to the U.S. market.
At the same time, at the beginning of 2026, Medinice signed a letter of intent with a global industry partner. The validity of the LOI was later extended until June 2026. The CoolCryo project is currently the subject of two parallel due diligence processes, confirming growing interest from potential strategic partners.
Ultimately, the company is considering the sale of the project, including rights to the technology and global patent protection, including in the U.S. and European markets.
According to the Management Board, completion of the clinical trial sends an important signal to investors and business partners. It reduces the project’s development risk, strengthens its clinical foundation and increases its commercial attractiveness.
CoolCryo is an innovative cryoablation technology designed for the treatment of conditions including atrial fibrillation through cardiac surgical cryoablation. The system was developed by Medinice’s scientific team under the leadership of Prof. Piotr Suwalski.
The use of liquid nitrogen as the cooling agent enables lower temperatures than those achieved by currently available solutions. This may shorten procedure time and improve both effectiveness and precision.
CoolCryo is one of Medinice S.A.’s key development projects. Another is PacePress, which successfully completed clinical trials in the third quarter of 2025. This further confirms the company’s ability to develop and validate innovative medical technologies.
