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VentriPoint Completes Validation Study for Pulmonary Arterial Hypertension Application
February 27, 2012 07:00 ET
VentriPoint Completes Validation Study for Pulmonary Arterial Hypertension Application
-Results show VMS™ has Equivalent Accuracy to Cardiac MRI-
SEATTLE, WASHINGTON--(Marketwire - Feb. 27, 2012) - VentriPoint Diagnostics (TSX VENTURE:VPT) (PINKSHEETS:VPTDF) announces it has completed the validation test, which compared the VentriPoint Medical System (VMS™) to cardiac Magnetic Resonance Imaging (MRI) in patients with Pulmonary Arterial Hypertension (PAH).
"This a world's first - accurate cardiac information with the convenience and speed of 2-D ultrasound", stated Dr. George Adams, VentriPoint President and CEO. "The Company will begin sales efforts for the PAH application in Europe and Canada as soon as regulatory approvals are received, which should be in the second calendar quarter this year."
The company will immediately begin to write the submission to the European Notified Body and Health Canada to extend its already received approvals to include PAH. A multicenter clinical trial in the United States has been in planning for many months and will now be initiated. As a first step, VentriPoint will install the VMS™ at each centre and train the sonographers and cardiologists. An announcement of the complete study design and the participants will be made as soon as contractual arrangements have been finalized.
The VMS™ is for investigational use only in the United States and is approved for clinical use in Canada and Europe.
About Pulmonary Arterial Hypertension
Pulmonary arterial hypertension (PAH) is the most serious form of the five recognized groups of pulmonary hypertension. PAH is a devastating disease with an average patient lifespan of less than 3 years after diagnosis if untreated. It affects individuals of all ages from infancy to the elderly. Although treatment started early after detection appears more effective than when started later, the majority of patients with PAH continue to be diagnosed too late for treatment to be fully effective. PAH can occur for no known reason but will typically occur in association with many common conditions such as chronic liver disease and liver cirrhosis; connective tissue disorders such as scleroderma or systemic lupus erythematosus (lupus); congenital heart disease (even if repaired) and HIV. With increasing availability of effective therapies, and evidence-based treatment guidelines recommending starting treatment early, tests enabling detection as early as possible should prove invaluable.
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. The VMS™ is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. Monitoring congenital heart disease is the first application in a suite of applications for all major heart diseases including pulmonary hypertension, cardiovascular disease and heart failure - a multibillion-dollar market potential. Canada and Europe (CE Mark) have granted approval for the sale of VentriPoint's VMS™ heart analysis system and VentriPoint is pursuing US-FDA approval 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.
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