Mr. Hugh MacNaught reports

VENTRIPOINT UPDATES SUBMISSION TO U.S. FOOD AND DRUG ADMINISTRATION FOR ITS NEXT GENERATION, AI-POWERED HEART-SCANNING TECHNOLOGY

Ventripoint Diagnostics Ltd. has reached another development milestone by updating the submission of its next generation of software, VMS+ 4.0, to the U.S. Food and Drug Administration for clearance. The update addresses questions regarding cybersecurity and artificial intelligence.

This latest advancement of Ventripoint's proprietary technology, VMS+ 4.0, delivers two significant enhancements to improve clinical workflows:

• Artificial-intelligence-assisted echocardiogram image analysis;
• Simplified sensors pairing workflow.

These new improvements are in addition to the benefits of VMS+ 3.0:

• Full-scope use so all patient groups can be easily scanned and assessed;
• Magnet-free sensors increasing the scope of patients who can benefit;
• Vendor-neutral interfacing with any ultrasound machine.

"Ventripoint is a pioneer in the application of AI to echocardiography and VMS+ 4.0 is the result of over two years of research and development," said Ventripoint president and chief executive officer Hugh MacNaught. "We are grateful for the collaboration by the Avania team to support this update to our submission. Upon FDA clearance, we look forward to offering U.S. hospitals one of the simplest, most effective, non-invasive heart-imaging tools available."

"Avania is proud to support Ventripoint on this important innovation. As a long-term partner, we have been continually impressed with Ventripoint's progress and the continual improvements they have made to their products," said Joel Ironstone, vice-president, regulatory and advisory services, for Avania. "We excitedly look forward to working with them on their next innovation."

Ventripoint updated its submission of VMS+ 4.0 for clearance by the FDA on Jan. 17, 2025, to meet a requirement for significant software and hardware updates and diagnostic advances. VMS+ 4.0 has already secured regulatory clearance in other key markets such as the European Union, United Kingdom and Canada, making this latest version of VMS+ available to the global community. Earlier versions of Ventripoint's scanning technology received FDA, Health Canada and E.U. regulatory approvals, and are being used by leading hospitals in the United States, EU, United Kingdom and Canada.

About Ventripoint Diagnostics Ltd.

Ventripoint is an industry leader in the application of AI 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 its 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.

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