Mr. Hugh MacNaught reports

VENTRIPOINT ANNOUNCES SUCCESSFUL COMPLETION OF KEY QUALITY AUDITS

Ventripoint Diagnostics Ltd. has successfully completed its annual audit under the medical device single audit program (MDSAP), ISO 13485 (quality management systems) and European Union Medical Device Regulation (MDR) requirements by a notified body. The audit resulted in zero major nonconformities and confirmed Ventripoint Diagnostics' continued compliance with global quality and regulatory standards.

This achievement reflects Ventripoint's continuing commitment to delivering safe, effective and high-quality medical devices to patients worldwide. It also reinforces the company's strong quality culture and dedication to meeting the evolving regulatory requirements across multiple jurisdictions. The audits addressed:

• MDSAP: The MDSAP audit, conducted by a third party auditing organization, ensures compliance with the medical device regulatory requirements of multiple jurisdictions, including the United States and Canada. This program streamlines the regulatory process, allowing Ventripoint to maintain certifications across these key markets efficiently.
• ISO 13485:2016 certification: ISO 13485:2016 is the globally recognized standard for quality management systems specific to the medical device industry. Passing this audit validates the company's comprehensive quality system, ensuring consistent performance, safety and product quality.
• MDR 2017/745: The successful audit under the European Union's MDR 2017/745 demonstrates that Ventripoint's products meet the rigorous new regulatory standards governing medical devices in the European market. This regulation focuses on patient safety, product traceability and postmarket surveillance, ensuring a high level of safety and performance for all medical devices sold in Europe.

"We are pleased to share that Ventripoint's dedication to maintaining a robust quality management system and ensuring that its products meet the stringent requirements of key international regulatory bodies is again reflected by a successful audit. This is an important aspect of our business that provides assurance to health care providers, patients and payers," said Ventripoint president and chief executive officer Hugh MacNaught. "The audit demonstrated that the advancements incorporated into VMS+4.0 were effectively managed within our quality system and provides confidence our team and processes will continue to meet the needs of our ongoing development and manufacturing programs."

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 (magnetic resonance imaging). 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 the company's 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 United States, Europe, and Canada.

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