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VentriPoint Receives Request for Clarification to 510 (k) Submission for Pulmonary Arterial Hypertension

Apr 25 2013 12:00AM

Marketwire

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SEATTLE, WASHINGTON -- (Marketwired) -- 04/25/13 -- VentriPoint Diagnostics (TSX VENTURE: VPT) (OTCQX: VPTDF) has received from the U.S. Food and Drug Administration (US-FDA) a short list of suggestions, clarifications and requests for additional information that they require to complete the review of the Pulmonary Arterial Hypertension (PAH) 510(k) submission. The Interactive Review Process was implemented by FDA to help facilitate the efficient and timely completion of premarket medical device submissions. The substantive review of the submission is now on hold until the Company responds.

The Company and its regulatory consultants are reviewing the list and through the Interactive Review Process will be seeking some clarification from the US-FDA on their comments.

"We are very pleased the FDA has reviewed our submission so expeditiously and we now have a small number of modifications to the filing to prepare," said, Dr. George Adams, CEO of VentriPoint.

PAH is the most serious form of the five recognized groups of pulmonary hypertension and is a devastating disease with an average patient lifespan of less than 3 years after diagnosis if untreated. It affects individuals from infancy to the elderly. Although treatment started early after detection appears more effective than when started later, the majority of patients with PAH continue to be diagnosed too late for treatment to be fully effective.

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

About VentriPoint Diagnostics Ltd.

VentriPoint has created diagnostic tools to monitor patients with heart disease, a leading cause of death in developed countries. Management believes that the VMS™ is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. The Company 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. Canada and Europe (CE Mark) have granted approval for the sale of its VMS-2DE™ product.

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.



Contacts:
VentriPoint Diagnostics Ltd.
Dr. George Adams
CEO
(206) 283-0221, ext. 401
gadams@ventripoint.com





Source: Marketwire