Medicalgorithmics S.A.

Regulatory Filings • Oct 17, 2024

Report Content Subject:Information on the Completion of the CE Certification Process for VCASTTechnology by Medicalgorithmics S.A._#160;

CurrentReport No: 22/2024_#160;

Date ofPreparation: October 17, 2024_#160;

Legal Basis:Article 17(1) of the MAR Regulation - confidential information.

The ManagementBoard of Medicalgorithmics S.A., based in Warsaw (_quot;Company_quot;; _quot;Issuer_quot;),informs that the Company has received notification from the notifiedbody T_#220;V Rheinland Polska Sp. z o.o. regarding the successful completionof the CE certification process for the VCAST software, designed fornon-invasive coronary artery disease diagnostics. The issuance of thecertificate for compliance with the requirements of the Medical DevicesRegulation 2017/745 (MDR) Annex IX Chapter I, Class IIa, Z129092, willoccur within the usual timeframe of several weeks following receipt ofthe notification.

The VirtualCardiac Stress Test (VCAST) is a technology that enables non-invasiveanalysis of coronary artery conditions for the diagnosis of coronaryartery disease. The diagnosis is based on data from cardiac CT images,analyzed by a set of artificial intelligence algorithms developed byKardiolytics Inc., the Issuer's American subsidiary. VCAST supportsdoctors in diagnosing coronary artery disease, offering a quick andnon-invasive alternative to traditional invasive diagnostic methods,such as coronary angiography.

The commencementof the VCAST technology certification process was reported by theManagement Board in current report No. 27/2023, published on October 3,2023.

In theManagement Board's opinion, receiving notification of the completion ofthe process and the pending issuance of the CE certificate for VCASTtechnology represents a significant milestone in the Company's strategy,enabling an intensification of efforts towards the commercialization ofthe technology. Upon obtaining the CE certificate, Medicalgorithmicswill begin the process of registering the VCAST technology in Poland(with the Office for Registration of Medicinal Products, MedicalDevices, and Biocidal Products). Following this, the solution will becommercially available in the European Union (and in some countriesafter additional national registration).

The CEcertificate also allows the Company to apply for product registrationwith national regulators in selected non-EU countries, such as theUnited Kingdom, Canada, Switzerland, or Australia, enabling VCAST to beoffered to customers outside the EU.

The Company alsoplans to apply to the FDA (U.S. Food and Drug Administration) forapproval to introduce the technology to the U.S. market under theso-called 510(k) procedure, about which the Company will inform in aseparate report.