TheManagement Board of Medinice S.A. with its registered office in Warsaw("Issuer") hereby informs about the completion of the clinicalinvestigation of the CoolCryo medical device, which confirms thecompleteness of the data and allows for the formal transition to thestage of results analysis and further regulatory work.
Thecompletion of subjects' participation in the clinical investigationconstitutes the basis for commencing the next stage of regulatory workon CoolCryo, including in particular the analysis of clinical data andthe preparation of documentation for the purposes of conformityassessment and CE marking in accordance with the requirements of the MDRRegulation.
Apositive assessment of the results of the clinical investigation will bean important element of the process aimed at obtaining CE marking,authorising the placing of the device on the market in the EuropeanUnion. Obtaining CE marking will complement the regulatory clearancesheld by the Issuer, including the U.S. Food and Drug Administration(FDA) clearance, strengthening the possibilities for commercializationof the device on international markets.
TheIssuer will inform about further material events concerning the CoolCryoproject by way of the relevant current reports.