Medinice S.A. submits a Premarket Notification 510(k) application to the FDA for the CoolCryo cryoablation system
June 24, 2025
Medinice S.A. announced that on June 23, 2025, it submitted a Premarket Notification 510(k) application to the US Food and Drug Administration (FDA) for its CoolCryo device, thereby initiating the formal regulatory review process. The standard review period for a 510(k) submission by the FDA is 90 days; however, the actual timeline for a decision may vary depending on potential requests for additional information. The Management Board will continue to keep the market informed about subsequent stages of the FDA review process.
"The submission of the 510(k) application represents a key milestone in the commercialization of CoolCryo in the world's largest medical device market. We would like to highlight the highly collaborative approach of the FDA team and express our gratitude for their substantive support during the series of pre-submission meetings. We are confident that this spirit of partnership will accelerate the review process and facilitate the swift approval of our technology for the US market." - says Sanjeev Choudhary, CEO of Medinice.
The potential approval of CoolCryo for commercialization in the US represents a pivotal milestone in Medinice's strategy to globally scale its innovative cardiac and electrophysiological technologies. The global cardiac ablation device market was valued at approximately $8 bn in 2024 and is projected to reach $18 bn by 2033.
The cardiac surgery cryoablation segment targeted by CoolCryo represents the fastest-growing niche within the entire ablation market. Regulatory clearance via the 510(k) pathway significantly reduces both regulatory risk and capital intensity compared to the PMA process, thereby substantially enhancing the ROI profile of the CoolCryo project," says Piotr Łoziński, CFO of Medinice S.A.
The CoolCryo system represents a breakthrough in surgical cryoablation of the heart, delivering unprecedented freezing power through the use of liquid nitrogen. An additional advantage is its flexible, heated applicator tip, designed to reduce procedure time and enhance the effectiveness of treating various cardiac arrhythmias. In May 2025, the CoolCryo system was introduced to the cardiothoracic surgery community during the 25th Annual Scientific Meeting of the International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) in Istanbul. The system attracted significant interest from specialists, leading to further upcoming presentations, which the company will announce in the near future.
See the slide deck from the conference call on June 24, 2025 [PL].See the video from the management presentation on June 24, 2025.About Medinice S.A.
Medinice is a medtech company listed on the Warsaw Stock Exchange, specializing in the development of a portfolio of novel solutions in cardiology and cardiac surgery. The company focuses on the design, clinical research, and commercialization of high-potential medical devices aimed at significantly improving patients' quality of life.
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