Q Patch technology registration delay – disclosure of delayed confidential information
Current report no.: 54/2022
Legal basis: Art. 17 sec. 1 of the MAR Regulation – confidential information
Management Board of Medicalgorithmics S.A. (“Company“, “Issuer“) informs that on September 20, 2022, in accordance with Art. 17 sec. 4 of the Regulation of the European Parliament and of the EU Council No. 596/2014 of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6 / EC of the European Parliament and of the Council and Commission Directive 2003/124 / EC, 2003/125 / EC and 2004/72 / EC, it decided to delay the disclosure of inside information to the public.
The confidential information concerned a change for a later date of obtaining full certification of the Q Patch technology, which technology gives the possibility of automatic analysis of the ECG signal using the Company’s algorithms. The issue of certification and its time horizon were disclosed by the Company in the current report No. 33/2022 of 03/06/2022.
The Issuer consulted with the American Food and Drug Administration (FDA; hereinafter “FDA“) on the detailed steps required to obtain the planned full certification. As a result of these consultations, the Company decided that it would not be beneficial for the Company to seek certification with the current algorithm under the Special 510(k) procedure on the previously indicated dates. Certification under the Special 510(k) procedure has a low chance of success. In addition the product certified this way may have little value from the point of view of diagnostics and the possibility of its development in relation to today’s and anticipated customer expectations.
The Management Board analyzed a number of available alternatives and decided that it would be optimal for the Company to obtain certification taking into account the latest generation of algorithms developed by the Company, based on the NextGen system and the DRAI algorithm, which algorithm itself recently obtained FDA certification, about which the Company informed in the current report No. 51 / 2022 from 28/07/2022. These activities require FDA certification in accordance with the Traditional 510(k) procedure.
Based on the conducted analyzes, the Management Board informs that it is not possible to provide the precise date of obtaining this certification. The Management Board estimates that it will take place between the second half of 2023 and the first half of 2024.
At the same time, the Management Board will analyze the possibilities of commercializing the device along with the algorithms currently implemented on the market in other markets outside the US.