Seattle, Washington, (Accesswire - September 26, 2013) - Ventripoint Diagnostics Ltd. ("Ventripoint") (TSXV:VPT) announces that it has received the complete dataset for the new analysis of the clinical trial in Pulmonary Arterial Hypertension ("PAH"). The Company previously reported the Food and Drug Administration ("FDA") had asked for additional information concerning the Company's submission for PAH. Through a dialogue with the FDA, the Company prepared a detailed statistical plan to obtain the information required. The Company completed the collection of an additional 21 clinical cases, which, along with the 54 studies used in the first analysis, yielded 75 total cases. This was the original plan for the clinical trial. The new analysis used all 75 cases and has been completed. The data have been sent for statistical computation. We expect the statistical results this week and expect to file a revised 510(k) submission addressing all the FDA's questions immediately thereafter.
"We thank the cardiology team at The Hospital for Sick Children in Toronto for completing the new analysis so diligently" said Jim Bodtke, Vice-President for Clinical Affairs for Ventripoint.
The VMS(TM) heart analysis system will enable physicians to quickly and non-invasively determine the size and function of the right heart - transforming patient care and reducing healthcare costs. Right heart function remains one of the most significant prognostic parameters in PAH.
The VMS(TM) is approved for clinical use in PAH patients in Canada and Europe and is for investigational use only in the United States.
About Ventripoint Diagnostics Ltd.
Ventripoint has created diagnostic tools 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. 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.
For further information, please contact:
Dr. George Adams, CEO
Telephone: (206) 910-9125
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FORWARD-LOOKING STATEMENTS: This news release may contain certain forward-looking information and statements, including without limitation, statements pertaining to the closing of the Offering including the Corporation's ability to obtain necessary approvals from the TSX Venture Exchange. 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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