Ventripoint Diagnostics Ltd.
TSX VENTURE : VPT

Ventripoint Diagnostics Ltd.

April 02, 2014 15:27 ET

Ventripoint VMS™ Heart Analysis System Used to Monitor Therapy in Pulmonary Hypertension and Valve Replacement in Congenital Heart Disease

SEATTLE, WASHINGTON--(Marketwired - April 2, 2014) - Ventripoint Diagnostics Ltd. ("Ventripoint") (TSX VENTURE:VPT) announces that following the clearance by the US Food and Drug Administration (FDA) of the VMS™ heart analysis system for right ventricle assessment in adult patients with Pulmonary Arterial Hypertension (PAH), the Company has focused on advancing marketing strategies, furthering partnership discussions for technology integration and establishing clinical studies to broaden the application of the VMS. We report today on the completion of two studies, one in PAH and one in congenital heart disease. Both studies verify the utility of the VMS™ in monitoring patients after treatment to determine if the therapy has been effective.

"The VMS™ is the first ultrasound system to be cleared as equivalent to MRI for right ventricle analysis," said Dr. George Adams, President and CEO of Ventripoint. "Now there is no need to wait to have an expensive MRI to functionally evaluate the right ventricle. We continue to build value for the Company by looking at all possible ways to market and advance the VMS™ with a focus on the upcoming cardiology meetings in the United States."

Right heart function remains a significant prognostic parameter for all heart disease. The recent clearance has paved the way to further our product's value by expanding its application to all major heart conditions. We have developed a regulatory strategy and although it is difficult to gauge timelines for FDA processes, we anticipate utilizing the Special 510(k) process using the VMS™ as the predicate device, and expect additional applications will be approved by the 3rd quarter this year.

We are pleased to announce that at the 13th International Pulmonary Hypertension Forum in Lisbon this week, Dr. Johannes Schwaiger of the Department of Cardiology at Royal Free Hospital in London will be lecturing on his experiences using the VMS™ to verify a significant change in RV ejection fraction after novel targeted treatments, which resulted in significant improvements in patients with PAH in a session entitled "Progress and future challenges in the management of PAH".

We are also pleased to report that the group at the Rikshospitalet University Hospital in Oslo, Norway, led by Dr. Henrik Brun, has published a paper in the Congenital Heart Disease Journal entitled "Right Ventricular Volumes Assessed by Echocardiographic Three-dimensional Knowledge-based Reconstruction Compared with Magnetic Resonance Imaging in a Clinical Setting". The paper reports on patients with Congenital Heart Disease, who had undergone pulmonary valve replacement and found excellent feasibility (97% of patients could be assessed) with VMS™ and clinically useful correlations with MRI for RV volumes. The paper concludes with the comment "Knowledge-based reconstruction [VMS] may replace MRI measurements for serial follow-up...".

The VMS™ is approved for clinical use in PAH patients in Canada and Europe, and now in the United States.

About Ventripoint Diagnostics Ltd.

Ventripoint has created tools to monitor patients with heart disease, a leading cause of death in developed countries. VMS™ is the first cost-effective and accurate tool for measuring right ventricle heart function. The Corporation has a suite of applications for all major heart diseases and imaging modalities including congenital heart disease, left or right heart failure and normal hearts - a multi-billion dollar market potential.

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

FORWARD-LOOKING STATEMENTS: The statements made in this news release that are not historical facts may 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. A description of assumptions used to develop such forward-looking information and a description of risk factors that may cause actual results to differ materially from forward-looking information can be found in Ventripoint's disclosure documents on the SEDAR website at www.sedar.com. 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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