Clinical Trial Achieved all the Primary Endpoints for Heart Analysis
Seattle, Washington, October 7, 2013 - Ventripoint Diagnostics Ltd. ("Ventripoint") (TSXV:VPT) announces it has completed the statistical analysis of its 75-patient, clinical trial in patients with Pulmonary Arterial Hypertension (PAH). The clinical trial achieved all its primary endpoints of accurately measuring the volume and ejection fraction of the right heart as compared to the traditional MRI analysis using the method of summation of disks.
Ventripoint has submitted a modified 510(K) application to the FDA for consideration for approval of the Ventripoint Medical System (VMS(TM)) for use in PAH. The submission addresses all the clarifications requested by the FDA and includes the analysis of the clinical data.
"These results from the PAH clinical trial are the best we could have imagined and we believe support the request for approval," said Dr. George Adams, President and CEO of Ventripoint. "People with PAH require frequent monitoring and adjustments to their treatments, which requires a detailed assessment of right heart function."
Right heart function remains one of the most significant prognostic parameters in PAH. The VMS heart analysis system enables physicians to quickly and non-invasively determine the size and function of the right heart - transforming patient care and reducing healthcare costs.
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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