Ventripoint Announces Successful Completion of Annual Quality and Regulatory Audits

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.

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.