

VentriPoint Launches Clinical Trial in Pulmonary Arterial Hypertension (PAH) With Top Pulmonary Hypertension Centres in the Uni
May 02, 2012 07:00 ET
VentriPoint Launches Clinical Trial in Pulmonary Arterial Hypertension (PAH) With Top Pulmonary Hypertension Centres in the United States and Canada
Dr. Robyn Barst is the Principal Investigator for the Clinical Trial
SEATTLE, WASHINGTON--(Marketwire - May 2, 2012) - VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) today announced the commencement of the pivotal clinical trial to demonstrate that the VentriPoint VMS™ heart analysis system is equivalent to cardiac MRI in patients with pulmonary arterial hypertension (PAH). The trial will be lead by Dr. Robyn Barst.
"With our successful pilot study completed and the PAH application validated, we are ready to start the clinical trial which will study 75 patients with PAH using both cardiac MRI and the VMS™ ultrasound approach," stated Dr. George Adams, CEO of VentriPoint. "It is exciting to have such a high-powered team conducting the study."
"If this technology if successful, it could revolutionize our ability to non-invasively assess disease severity and the effects of therapeutic interventions - minimizing the need for frequent invasive cardiac catheterizations" stated Dr. Robyn Barst.
The clinical site and the lead clinical investigators at each site are: |
Allegheny | Pittsburgh, PA | Dr. Ray Benza |
Baylor | Houston, TX | Dr. Adaani Frost |
Brigham and Women's | Boston, MA | Dr. Aaron Waxman |
Cleveland Clinic | Cleveland, OH | Dr. Richard Krasuski |
Johns Hopkins | Baltimore, MA | Dr. Paul Hassoun |
Toronto General Hospital | Toronto, ON | Dr. John Granton |
University of Chicago | Chicago, IL | Dr. Mardi Gomberg-Maitland |
The Company's expectation is the study results will be satisfactory and supportive of a 510 (k) submission to the US FDA. The Company will be installing VMS™ devices at the centres that do not already have a system. The individual clinical centres will begin recruiting patients as soon as they are operational. It is expected all sites will be operational in May and the study will take 3 months to complete for submission 3Q12 and a response from FDA within the mandatory 90 days.
The VMS™ is for investigational use only in the United States and is approved for clinical use in Canada and Europe.
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 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 its VMS™ diagnostic tool and is pursuing the US-FDA approval through the 510(k) process.
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