Toronto, Ontario (September 24, 2026) – TheNewswire - Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company"), (TSXV:VPT; OTC:VPTDF) today announced the completion of its annual quality and regulatory audits covering the Medical Device Single Audit Program (MDSAP), ISO 13485:2016 Quality Management System and the European Union Medical Device Regulation (MDR 2017/745).

The completion of the audits confirms the continued effectiveness of Ventripoint’s quality management system and its conformity with the applicable quality and regulatory requirements governing the development and manufacture of its medical devices in key international markets that are regulatory approved/cleared.

The successful audits are particularly relevant as Ventripoint continues to advance the commercialization of its VMS+ cardiac imaging platform and expand its activities across multiple markets. Maintaining these certifications provides an important foundation for ongoing product development, manufacturing and international market access.

The scope of the audits included:

Medical Device Single Audit Program (MDSAP): MDSAP provides a common framework for assessing compliance with medical device regulatory requirements in participating jurisdictions, including the United States and Canada. Successful completion supports Ventripoint’s ability to maintain its regulatory standing across these important markets through a coordinated audit process.

ISO 13485:2016: This internationally recognized standard establishes requirements for quality management systems applicable to medical device manufacturers. Ventripoint’s successful audit confirms the continued operation of a quality system designed to support consistent product performance, safety and manufacturing quality.

EU Medical Device Regulation (MDR 2017/745): Completion of the MDR surveillance audit supports Ventripoint’s continued conformity with applicable EU Regulation 2017/745 , including requirements relating to safety, performance, traceability and post-market surveillance.

 

“We are pleased with the successful completion of these audits, which provide further confirmation of the strength and maturity of Ventripoint’s quality and manufacturing processes,” said Hugh MacNaught, President and CEO of Ventripoint. “The successful TÜV manufacturing audit completed in August, together with this latest review of our quality management system, demonstrates that our processes are supporting both the continued development of VMS+ 4.0 and the requirements of an expanding commercial business. Maintaining rigorous quality standards across product design and development, manufacturing, production and software validation, and regulatory compliance is essential as we increase adoption of VMS+ and expand into additional markets.”

About Ventripoint Diagnostics Ltd.

Ventripoint is an industry leader in the application of AI (Artificial Intelligence) to echocardiography. Ventripoint's VMS products are powered by its proprietary Knowledge Based Reconstruction technology, which is the result of a decade of development and provides accurate volumetric cardiac measurements equivalent to MRI. This affordable, gold-standard alternative allows cardiologists greater confidence in the management of their patients. Providing better care to patients serves as a springboard and basic standard for all of Ventripoint's products that guide our future developments. In addition, VMS+ is versatile and can be used with all ultrasound systems from any vendor supported by regulatory market approvals in the U.S., Europe, and Canada.

For further information, please contact:

Hugh MacNaught

hmacnaught@ventripoint.com

604-671-4201

 

Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this news release.

 

Forward Looking Statements

This news release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. The use of any of the words "expect", "anticipate", "continue", "estimate", "objective", "ongoing", "may", "will", "project", "should", "believe", "plans", "intends'' and similar expressions are intended to identify forward-looking information or statements. The forward-looking statements and information are based on certain key expectations and assumptions made by the Company. Although the Company believes that the expectations and assumptions on which such forward-looking statements and information are based are reasonable, undue reliance should not be placed on the forward-looking statements and information because the Company can give no assurance that they will prove to be correct.

Since forward-looking statements and information address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results could differ materially from those currently anticipated due to a number of factors and risks. Factors which could materially affect such forward-looking information are described in the risk factors in the Company's most recent annual management's discussion and analysis that is available on the Company's profile on SEDAR at www.sedar.com. Readers are cautioned that the foregoing list of factors is not exhaustive. The forward-looking statements included in this news release are expressly qualified by this cautionary statement. The forward-looking statements and information contained in this news release are made as of the date hereof and the Company undertakes no obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws.