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VentriPoint Announces FDA 510(K) Submission for VMS(TM) Heart Analysis System for Pulmonary Arterial Hypertension
First Quantitative 2D-Ultrasound System for Pulmonary Arterial Hypertension
By: Marketwired .
Jan. 31, 2013 06:40 PM
SEATTLE, WASHINGTON -- (Marketwire) -- 01/31/13 -- VentriPoint Diagnostics (TSX VENTURE:VPT) (OTCQX:VPTDF) announced today that it has submitted to the U.S. Food and Drug Administration (FDA), for 510(k) clearance, the first 2D-ultrasound right-heart analysis system in patients with Pulmonary Arterial Hypertension (PAH). 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.
"This submission marks an important corporate milestone and represents the culmination of several years of dedicated work by VentriPoint and the support of our clinical collaborators at major cardiac centres in the United States, Europe and Canada," commented Dr. George Adams, CEO of VentriPoint. "I would like to thank Dr. Scott Solomon and his team at Harvard Brigham & Women's Hospital for performing the core-lab analysis in the clinical trial, which compared VMS(TM) to conventional cardiac MRI."
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 a diagnostic ultrasound tool 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. Congenital heart disease in children and adults and pulmonary arterial Hypertension are the first applications in a suite of applications for all major heart diseases including cardiovascular disease and heart failure - a multi-billion dollar market potential. Canada and Europe (CE Mark) have granted approval for the sale of its VMS(TM) tool and the company is pursuing the US-FDA marketing clearance through the 510(k) process.
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
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