VentriPoint Diagnostics Receives CE Mark for Its NRV Application
Published: Apr 17, 2013
"Leading cardiologists, who have the VMS-2DE™ heart analysis system, have been requesting the NRV™ application so they can examine almost every patient they see," said Dr. George Adams, CEO of Ventripoint. "This approval will allow our sales force to offer this major expansion of the capability of the VMS-2DE™ to our existing and pending customers in Europe, where heart disease remains the leading cause of death at a financial cost of 196 billion Euros each year."
The NRV™ database will be used with the VMS-2DE™ heart analysis system for patients where knowledge of the function of the right heart would be useful in assessing the overall heart function and optimally treat the patient. It is estimated that 27 million people have some form of heart disease and the addition of this application to the VMS™ heart analysis systems will provide a direct avenue for clinicians to better evaluate and care for these individuals. It is anticipated that the NRV™ application can also be used to provide a reference baseline study for patients at risk for developing right heart dysfunction and would benefit from frequent monitoring.
The VMS-2DE™ is approved for clinical use in Europe and Canada and is available for investigational use only in the United States.
The company is also announcing it has passed the annual surveillance audit its quality management system and has received renewal compliance certificates for ISO 13485:2003/CMDCAS and MDD 93/42/EEC - Annex II standards. These certificates are required to maintain the Company's licenses to sell its medical devices in Europe and Canada.
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.
VentriPoint Diagnostics Ltd.
Dr. George Adams
(206) 283-0221, ext. 401