Ventripoint Applies to US FDA for Market Clearance for the VMS+ Whole-Heart Analysis System
Toronto, Ontario, January 17, 2018 – Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”, TSXV:VPT) is pleased to announce that it has submitted a traditional 510(k) application to the FDA’s Center for Devices and Radiological Health (CDRH) to request clearance for sale of the VMS+ whole-heart analysis system.
“Once again, I commend our regulatory and development teams for this milestone event,” stated Dr. George Adams, CEO of Ventripoint. “The Company is focused on making cardiac ultrasound assessments faster, easier and available to all to overcome the costs, delays and limitations of cardiac MRI.”
The Company has submitted a new FDA 510(k) to extend the capabilities of our current model to all 4 chambers of the heart. The submission uses the existing VMS as the predicate device and provides testing data to show that the databases for the left atrium, right atrium and left ventricle perform equally well in assessing the chamber volumes in a wide variety of heart conditions, and shapes and sizes of hearts. The volumes and ejection fraction determination by VMS+ were equivalent to MRI measurements, which is the gold standard for these types of cardiac assessments. The data also demonstrate excellent reproducibility between operators.
The submission references the data wherein Ventripoint assessed and measured the safety, quality, and performance of the product. As previously announced (See NR December 19, 2017) the VMS+ device has passed the ISO 60601 testing.
About Ventripoint Diagnostics Ltd.
Ventripoint’s technology is a leading Artificial Intelligence (AI) approach known as Knowledge-Based Reconstruction (KBR) to create applications to monitor heart disease, a leading cause of death worldwide. The VMS+ is the first cost-effective and accurate AI tool for measuring whole heart function using conventional ultrasound. The Corporation has developed a suite of applications for all major heart diseases and is actively commercializing the approach to improve cardiac care.
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FORWARD-LOOKING STATEMENTS: The statements made in this press release that are not historical facts contain forward-looking information that involves risk and uncertainties. All statements, other than statements of historical facts, which address Ventripoint’s expectations, should be considered forward-looking statements. Such statements are based on management’s exercise of business judgment as well as assumptions made by and information currently available to management. When used in this document, the words "may", "will", "anticipate", "believe", "estimate", "expect", "intend" and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect a current view of future events and are subject to certain risks and uncertainties as contained in the Corporation's filings with Canadian securities regulatory authorities. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements. The Corporation undertakes no obligation, and does not intend, to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of any unanticipated events. Although management believes that expectations are based on reasonable assumptions, no assurance can be given that these expectations will materialize.