SEATTLE, WASHINGTON--(Marketwired - Mar 16, 2015) - Ventripoint Diagnostics Ltd. ("Ventripoint") (TSX VENTURE:VPT) is pleased to announce that it has recently filed an additional submission for 510(k) clearance to the U.S. Food & Drug Administration (FDA).
"The subject matter of the recent submission centers around the addition of Ventripoint's newest catalog, simply named 'Right Ventricle', which was developed to provide right ventricular volumes of individuals being evaluated, regardless of their cardiac diagnosis" stated Dr. George Adams, CEO of Ventripoint. "Clearance by the U.S. FDA will greatly increase the utility and market adoption of the Ventripoint Medical System (VMS™)."
According to Jeff Jellum, Director of Operations for Ventripoint, the submission is a traditional 510(k), however, it differs greatly from previous submissions. Mr. Jellum stated "Previous submissions to the FDA required us to prove the methodology, safety, and accuracy of the entire VMS product to the reviewers, which was challenging with such novel technology. By referring to our cleared product throughout the current submission as a Predicate Device, our path forward becomes much more predictable."
In terms of the significance of the current submission and its impact on the market, Jim Bodtke, V.P. Clinical Affairs and Development for Ventripoint, offered the following statement. "Heart disease is the number one killer of adults, taking more lives each year than all forms of cancer combined. With more than 27 million individuals in the U.S. alone that are living with cardiac disease, there is not a single person that will not be affected by this statistic at some point in their life. Our goal is to provide a product that will positively impact the outcomes for many of these individuals, regardless of their cardiac diagnosis. By gaining the additional clearance with this submission, we will be able to greatly increase the marketability of the VMS product."
The submission will involve a review process of up to 90 days from the date of acceptance by the US FDA.
About Ventripoint Diagnostics Ltd.
Ventripoint has created tools to monitor patients with heart disease, a leading cause of death in developed countries. VMS™ is the first cost-effective and accurate 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.
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FORWARD-LOOKING STATEMENTS: The statements made in this news release that are not historical facts may 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. 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.