Ventripoint Receives Market Clearance from US-FDA for Complete Heart Analysis System
using 2D Ultrasound
Toronto, Ontario – May 15, 2018 - Ventripoint Diagnostics Ltd. (“Ventripoint” or the “Company”) (TSXV:VPT) announces that it has received market clearance from the US Food and Drug Administration (“FDA”) to sell its VMS+™ machine with the 4-chamber heart analysis system in the United States. The intended use is for the analysis of ejection fraction (function) and volumes of any chamber of the heart, where they are warranted or desired.
”The VMS+ is the first simple echocardiography system to be approved by the FDA for the 3D volumetric analysis of all four chambers of the heart using 2D ultrasound,” stated Dr. George Adams, CEO of Ventripoint. “Now we can offer the VMS+ to American physicians so they can accurately and easily evaluate and monitor hearts in children and adults during a routine cardiology appointment.” The USA is the largest medical device market in the world with over 40 million cardiac ultrasound exams per year. 2D ultrasound is the modern stethoscope and is employed worldwide as the first step in evaluating heart disease. The VMS+ product allows for the determination of heart function, expressed as ejection fraction or volumes of any of the four chambers of the heart using conventional 2D ultrasound. These measurements are increasingly recognized as critically important in monitoring the heart and predicting outcomes of patients. This applies to patients with heart failure, abnormal heart rhythms, congenital heart disease, pulmonary hypertension and hypertension. With the VMS+, it is now possible to obtain this valuable information quickly, easily and cost effectively. Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
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.
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For further information please contact:
George Adams, CEO
Phone: (519) 803-6937
Email: gadams@ventripoint.com
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