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

SEATTLE, WASHINGTON--(Marketwired - April 25, 2013) - 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.

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