Mr. Hugh MacNaught reports

VENTRIPOINT DIAGNOSTICS ANNOUNCES U.S. FDA 510(K) CLEARANCE FOR VMS+(TM) 4.0 AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE/SYSTEM

Ventripoint Diagnostics Ltd. has received United States Food and Drug Administration (FDA) 510(k) clearance for the VMS+ 4.0 automated radiological image processing software/system.

This latest advancement of Ventripoint's proprietary technology, VMS+ 4.0, delivers a number of significant enhancements including:

• Artificial-intelligence-assisted automated point placement to improve user workflow efficiency;
• Magnet-free sensors enabling more efficient pairing and improved workflow;
• User tools to assist with analysis of the cardiac views;
• Enhanced visualization tools;
• Measurements generated from the 3-D wire mesh:
  • ED volume;
  • ED volume index;
  • ES volume;
  • ES volume index;
  • Ejection fraction;
  • Cardiac output;
  • Cardiac index;
  • Stroke volume;
  • Stroke volume Index.
• Eporting of all measurements and derived parameters.

In addition, the introduction of the magnet-free sensors to VMS+ 4.0 enables VMS+ to be used for patients with cardiac pacemakers. There are an estimated three million people in the U.S. with cardiac pacemakers who are unable to be imaged with MRI and who depend on echocardiography to monitor their heart disease. VMS+ is unique in its ability to report volumes and ejection fractions for all four chambers of the heart with MRI levels of accuracy.

The VMS+ 4.0 system connects to standard echocardiography machines, the most widely used cardiac imaging technology globally. The system uses Ventripoint's proprietary knowledge-based reconstruction technology to create 3-D images of the heart and calculates volumes and ejection fraction for all four cardiac chambers with accuracy equivalent to MRI. The system can reduce the need for MRI in children and adults.

"Ventripoint has deep experience in the application of AI to echocardiography and this FDA clearance is the culmination of more than two years of research and development," said Ventripoint president and chief executive officer Hugh MacNaught. "We are thrilled with the opportunity to offer U.S. hospitals an efficient and effective, non-invasive heart-imaging tools available. AI enhanced echocardiograms are a fast, affordable and accessible tool for diagnosis and monitoring of the growing numbers of cardiac patients in America and worldwide."

VMS+ 4.0 has already received 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 EU 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 (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 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 U.S., Europe and Canada.

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