The Company anticipates submitting the application for VMS-3DE for European CE Mark, Health Canada in the next 90 days and intends to seek FDA approval later this year.
About 3D Echocardiography
3D ultrasound captures in a single snapshot a complete 3D image of the heart. Like 2D ultrasound it has to be focused between the ribs and so has a narrow "window" to view the heart. The right heart is especially hard to image and often only a portion of the heart is captured making it impossible to analyze the beating heart functions. However, some people have good windows and small hearts and so a complete image can be obtained. Due to the complex shape of the right heart, it still requires an expert to identify the heart muscle from the blood in the heart. This can take many iterations and a lot of time. Nevertheless, Phillips, General Electric, Toshiba and Siemens have continued to improve their 3DE machines and they are now beginning to be used in paediatric centres to do quantitative analysis of the right ventricle.
About VentriPoint Diagnostics Ltd.
VentriPoint has created a diagnostic ultrasound tool to monitor patients with heart disease, a leading cause of death in developed countries. VMS is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. Congenital heart disease in children and adults and pulmonary arterial Hypertension are the first applications in a suite of applications for all major heart diseases including cardiovascular disease and heart failure - a multi-billion dollar market potential. Canada and Europe (CE Mark) have granted approval for the sale of its VMS tool and the Company is pursuing the US-FDA marketing clearance through the 510(k) process.
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.
Neither 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 release
VentriPoint Diagnostics Ltd.
Dr. George Adams
(206) 283-0221, ext. 401
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