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Medicalgorithmics S.A. — Regulatory Filings 2023
Oct 3, 2023
5705_rns_2023-10-03_33e21b58-9d7a-4c5d-81d5-207ff94c5d88.html
Regulatory Filings
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Subject:Information on the conclusion by Medicalgorithmics S.A. of an agreementwith a certification body regarding CE certification of VCAST technology
Currentreport no.: 27/2023
Date ofpreparation: October 3, 2023
Legal basis:Article 17(1) of the MAR Regulation - inside information.
The ManagementBoard of Medicalgorithmics S.A. with its registered office in Warsaw(the _quot;Company_quot;; _quot;Issuer_quot;) informs about theconclusion of an agreement with T_#220;V Rheinland Polska Sp. z o.o.concerning among others: extension audit for compliance with therequirements of the Medical Devices Regulation 2017/745 (MDR) AppendixIX Chapter I (_quot;Agreement_quot;).
The subject of theAgreement includes among other: (i) certification of the VCASTtechnology developed at the Company's subsidiaryKardiolyticsInc.,_#160;for compliance with therequirements of the Medical Devices Regulation 2017/745 (MDR) Annex IXChapter I, category IIa, Z129092.
Obtaining EUcertification for compliance with Regulation 2017/745 (MDR) allows tostart the registration process in the following markets: European Union,Australia, UK, Switzerland, and Asia.
The initiation ofthe VCAST technology certification process marks the achievement of amilestone in the Company's strategy for the years 2023-2026 concerningthe development of VCAST technology, as published in the current reportNo. 16/2023 dated June 19, 2023. Therefore, the Company's Managementdecided to release this information, deeming it confidential as per theMAR Regulation, to the public. The execution of the certification willenable the Company to commercialize the VCAST technology in the EuropeanUnion markets, including Poland, and will expedite certification andcommercialization in Asian markets (as described above). This couldpotentially lead to increased company revenue in 2024, provided thecertification process concludes positively. The Company will announcethe completion of the certification process in a separate issuer'scurrent report.