Medinice S.A.

Regulatory Filings • Mar 10, 2025

The Management Board of MEDINICE S.A., based in Warsaw (the "Company"),referring to ESPI 18/2021 dated May 25, 2021, regarding the approvalreceived from URPL for conducting clinical trials in the PacePressproject, and to ESPI 42/2024 dated December 19, 2024, concerning theachievement of a key milestone in the PacePress clinical trialnamely,enrolling the required number of patients to initiate the InterimAnalysishereby announces that today, the Company has received apositive Interim Analysis Report from the CRO.

The objective of the Clinical Trial was to assess the safety andeffectiveness of PacePress in preventing hemorrhagic complications inpatients at high risk of bleeding undergoing procedures such as primaryimplantation (CIED implantation), system replacement (ICD, CRT), systemexpansion, or lead revision. The results of the Interim Analysisdemonstrated significant differences in the effects of theinvestigational PacePress dressing compared to a standard dressing.

Based on the obtained results, the Management Board has decided thatthere is no need to continue the clinical trial. This decision will havea positive impact on the ongoing project costs and facilitate itscommercialization.