Medinice S.A. obtains positive Interim Analysis results in the clinical trial of PacePress^® - early completion and a quick step towards certification

March 10, 2025

Medinice S.A. announced that it has received a positive Interim Analysis report from the clinical trial of the innovative PacePress^® dressing. The study demonstrated significantly better outcomes in preventing hemorrhagic complications, including hematomas, after CIED implantation procedures, compared to the standard dressing used to date.

The Interim Analysis, prepared by KCRI (CRO), included 124 patients treated either with PacePress^® or with a standard dressing. The results showed statistically significant differences in favor of PacePress^®, confirming its clinical superiority.

In light of these results, the Management Board of Medinice S.A. made the key decision to terminate the clinical trial early, enabling cost optimization and accelerating the commercialization process of the device. As emphasized by the company's CEO, Sanjeev Choudhary: "This is the first completed clinical trial in the history of Medinice. Once the trial is closed, we will gain access to data that will allow us to move forward with large-scale commercialization efforts."

In its Q1 2025 report, the company highlighted that the outcome of the Interim Analysis has made it possible to start preparations for obtaining CE MDR certification for the PacePress Fast system. This marks an important step in the implementation of Medinice’s strategy to bring its products to European and global markets.