Current report no.: 27/2023
Date of preparation: October 3, 2023
Legal basis: Article 17(1) of the MAR Regulation – inside information.
The Management Board of Medicalgorithmics S.A. with its registered office in Warsaw (the “Company“; “Issuer“) informs about the conclusion of an agreement with TÜV Rheinland Polska Sp. z o.o. concerning among others: extension audit for compliance with the requirements of the Medical Devices Regulation 2017/745 (MDR) Appendix IX Chapter I (“Agreement”).
The subject of the Agreement includes among other: (i) certification of the VCAST technology developed at the Company’s subsidiary Kardiolytics Inc., for compliance with the requirements of the Medical Devices Regulation 2017/745 (MDR) Annex IX Chapter I, category IIa, Z129092.
Obtaining EU certification for compliance with Regulation 2017/745 (MDR) allows to start the registration process in the following markets: European Union, Australia, UK, Switzerland, and Asia.
The initiation of the VCAST technology certification process marks the achievement of a milestone in the Company’s strategy for the years 2023-2026 concerning the development of VCAST technology, as published in the current report No. 16/2023 dated June 19, 2023. Therefore, the Company’s Management decided to release this information, deeming it confidential as per the MAR Regulation, to the public. The execution of the certification will enable the Company to commercialize the VCAST technology in the European Union markets, including Poland, and will expedite certification and commercialization in Asian markets (as described above). This could potentially lead to increased company revenue in 2024, provided the certification process concludes positively. The Company will announce the completion of the certification process in a separate issuer’s current report.