TheManagement Board of Medinice S.A. (the "Company") hereby informs that on 06March 2026 the Company submitted to the U.S. Food and DrugAdministration (FDA) a pre-submissionrequest under the Q-Submission (Q-Sub) program concerning the AtriClampproject. Together with the request, the Company providedthe FDA with documentation intended for preliminary review prior to themeeting.Thepurpose of the meeting under the pre-submission is to obtain feedbackfrom the FDA with respect to the submitted documentation, in particularregarding the scope and manner of conducting the planned preclinicalstudies and their adequacy for the purposes of the subsequent stages ofthe regulatory process for the AtriClamp project.
Inaccordance with FDA procedures, the date of the meeting is set by theAgency within standard timeframes, generally within 75 days fromsubmission of the request.
TheCompany will inform about further material events concerning theAtriClamp project in accordance with its disclosure obligations.