|By Marketwire .||
|May 2, 2012 07:00 AM EDT||
SEATTLE, WASHINGTON -- (Marketwire) -- 05/02/12 -- VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) today announced the commencement of the pivotal clinical trial to demonstrate that the VentriPoint VMS(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) diagnostic tool and is pursuing the US-FDA approval through the 510(k) process.
Cautionary Note Regarding 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