(TheNewswire)
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VMS+4.0 submitted to FDA on May 1 for clearance
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Ventripoint will market new advances after FDA clearance
Toronto, Ontario – TheNewswire - May 6, 2024 - Ventripoint Diagnostics Ltd. ("Ventripoint" or the "Company"), (TSXV:VPT); (OTC:VPTDF) has reached another development milestone by submitting its next generation of software, VMS+4.0, to the U.S. Food and Drug Administration (“FDA”).
This latest advance of Ventripoint’s AI-powered technology, which rapidly processes ultrasound images of the heart to generate MRI-quality measurements of all four cardiac chambers, will seamlessly integrate into the workflow of hospitals, clinics and caregivers.
The advances achieved by VMS+4.0 means Ventripoint’s heart-scanning technology will now offer:
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Novel presentation of full cardiac motion of all four 3D reconstructed chambers of the heart through the cardiac cycle.
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Automated plotting of key anatomical landmarks of the heart, removing the need for manual inputs and providing greater confidence in the analysis. This provides greater reliability, consistency and reproducibility of the volumetric measurements.
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Increased analysis speed, making heart images available in minutes, not the hours needed for MRI imaging.
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Full-scope use — meaning newborns to adults can be easily scanned and assessed.
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Magnet-free sensors, reducing procedure time by eliminating a calibration procedure.
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Interfaced with any ultrasound machine within minutes.
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Enhanced visualization tools including strain and heat maps.
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Breakthrough vector-motion technology to show the wall movement of the different chambers of the heart. This provides a novel and unique way of visualizing the motion of the heart including twist.
“It has taken our team two years of research and development to reach this major milestone,” said Ventripoint Interim CEO, Hugh MacNaught. “With VMS+4.0, we will now be offering the world’s hospitals one of the simplest, most effective, non-invasive heart-imaging tools in the market.”
Ventripoint submitted VMS+4.0 for clearance by FDA on May 1, a requirement for significant software and hardware updates and diagnostic advances. We are also pursuing regulatory clearance in other key markets such as the E.U., U.K and Canada to make this newest version of Ventripoint available to the global community. Ventripoint’s current scanning technology has already received FDA, Health Canada and similar regulatory approvals in the United Kingdom and the European Union, and is being used by leading hospitals in the U.S., E.U., U.K. 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 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:
Jonathan Robinson
416-669-1001
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.
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