Current Report No: 22/2024
Date: 17.10.2024 r.
Legal Basis: Article 17(1) of the MAR Regulation – confidential information.
The Management Board of Medicalgorithmics S.A., based in Warsaw (“Company”; “Issuer”), informs that the Company has received notification from the notified body TÜV Rheinland Polska Sp. z o.o. regarding the successful completion of the CE certification process for the VCAST software, designed for non-invasive coronary artery disease diagnostics. The issuance of the certificate for compliance with the requirements of the Medical Devices Regulation 2017/745 (MDR) Annex IX Chapter I, Class IIa, Z129092, will occur within the usual timeframe of several weeks following receipt of the notification.
The Virtual Cardiac Stress Test (VCAST) is a technology that enables non-invasive analysis of coronary artery conditions for the diagnosis of coronary artery disease. The diagnosis is based on data from cardiac CT images, analyzed by a set of artificial intelligence algorithms developed by Kardiolytics Inc., the Issuer’s American subsidiary. VCAST supports doctors in diagnosing coronary artery disease, offering a quick and non-invasive alternative to traditional invasive diagnostic methods, such as coronary angiography.
The commencement of the VCAST technology certification process was reported by the Management Board in current report No. 27/2023, published on October 3, 2023.
In the Management Board’s opinion, receiving notification of the completion of the process and the pending issuance of the CE certificate for VCAST technology represents a significant milestone in the Company’s strategy, enabling an intensification of efforts towards the commercialization of the technology. Upon obtaining the CE certificate, Medicalgorithmics will begin the process of registering the VCAST technology in Poland (with the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products). Following this, the solution will be commercially available in the European Union (and in some countries after additional national registration).
The CE certificate also allows the Company to apply for product registration with national regulators in selected non-EU countries, such as the United Kingdom, Canada, Switzerland, or Australia, enabling VCAST to be offered to customers outside the EU.
The Company also plans to apply to the FDA (U.S. Food and Drug Administration) for approval to introduce the technology to the U.S. market under the so-called 510(k) procedure, about which the Company will inform in a separate report.