VentriPoint Diagnostics Ltd.

VentriPoint Diagnostics Ltd.

September 20, 2011 09:20 ET

VentriPoint Launches Multicenter Clinical Trial for FDA Submission

Nationwide also to Study Difficult-to-Image Patients Undergoing Valve Replacement

SEATTLE, WASHINGTON--(Marketwire - Sept. 20, 2011) - VentriPoint Diagnostics (TSX VENTURE:VPT) (PINK SHEETS:VPTDF) today announced the start of a clinical trial to validate its VMS™ 3D imaging technology in patients with the most common form of congenital heart disease, Tetralogy of Fallot or Blue-baby Syndrome. This trial is being led by Dr. John Kovalchin, Director of Echocardiography at The Heart Center at Nationwide Children's Hospital in Columbus Ohio. Dr. Kovalchin has already enrolled eight patients into the trial, which is planned to enroll a total of 83 patients at five centers in the United States. Other centers will be announced as they begin enrollment.

"We are pleased to be collaborating with VentriPoint on this project" said Dr. Kovalchin.

Data from the trial will underpin a submission to the FDA, which is slated for the end of this year.

According to Dr. George Adams, CEO, "With this trial, the company is positioning itself to become the standard of care for measuring right ventricular volumes in a manner that is cost-effective, accessible and accurate".

In addition to the multicenter trial, Dr. Kovalchin and his colleagues will be evaluating the risks and benefits of the VMS™ in difficult-to-image adult and pediatric patients. They will explore the usefulness of the VMS in the 'hybrid cath lab'* for the assessment of right-ventricular function before and after percutaneous-valve replacement.

*(A hybrid catheterization lab combines diagnostic functions, e.g. 'cath' lab, with the surgical functions of an operating room.)

The VMS™ is an investigational use device only in the United States and approved for clinical use in Canada and Europe.

About John Kovalchin, M.D.

John P. Kovalchin, MD, is Director of Echocardiography at The Heart Center at Nationwide Children's Hospital and Associate Professor of Pediatrics at The Ohio State University College of Medicine. Dr. Kovalchin received his medical degree from the Northeastern Ohio Universities College of Medicine. He completed his residency at Nationwide Children's Hospital and fellowships at Texas Children's Hospital and the University of California Medical Center Parnassus. He is certified in both Pediatric Cardiology and Pediatrics.

About Nationwide Children's Hospital

Nationwide Children's Hospital has been ranked in the top 10 in Cardiology/Heart Surgery in U.S. News Media Group's Best Children's Hospitals 2011-12 rankings ( The Heart Center at Nationwide Children's has expertise, compassion and the most-advanced technologies. Pediatric and adult patients with all forms of congenital heart disease and acquired cardiomyopathy have access to world-class diagnostic, treatment and research facilities. The Research Institute at Nationwide Children's Hospital is one of the nation's ten largest free-standing pediatric research centers and works to enhance the health of children by engaging in high-quality, cutting-edge research.

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. 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 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.

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