Ventripoint Receives Marketing Clearance from the FDA to Expand
the Use of the VMS Heart Analysis System
Seattle, Washington, May 22, 2015 – Ventripoint Diagnostics Ltd. ("Ventripoint") (TSXV:VPT) is pleased to announce that it has received Marketing Clearance from the U.S. Food & Drug Administration ("FDA") for the expanded Indications for Use of its VMS™ product which states; "The VMS system is indicated for use where RV (Right Ventricle) volumes and ejection fractions are warranted or desired".
"This change in use criteria means physicians in the USA can now use the VMS on patients that they believe will benefit from assessment of RV function, without being limited to a specific condition", stated Jim Bodtke, Vice-President, Clinical Affairs and Development for Ventripoint. "Accurate RV volume assessment is the key to the full understanding or treatment of many heart conditions, and the VMS is the only method on the market that provides results that are widely considered as accurate as the Gold Standard, MRI."
Previously the VMS was limited in use on adults with known Pulmonary Arterial Hypertension (PAH) which is newly diagnosed in approximately 200,000 individuals each year in the USA. Now the VMS can be used on the more than 20,000,000 people in the U.S. that suffer from heart disease.
The information about the function of the RV is known to predict the course of heart disease and can be used by the cardiologist to determine how frequently to evaluate the patient. Heart disease remains the leading cause of death globally with the RV being the determining factor for the vast majority of patient outcomes. The only comparable method used ith Cardiac Ultrasound to assess RV function is Real Time 3D Echo, which is widely accepted as being inaccurate in terms of volumetric data. Other methods of obtaining functional RV data are inconvenient and can take hours (MRI) or involve high doses of radiation (CT Scan). Further, both MRI and CT Scan may require the injection of Contrast, which can be detrimental in patients with concerns for Kidney failure.The use of VMS overcomes all of the concerns related to MRI and CT, from the most widely used method in the world for heart evaluation, that being 2D Echo. This remains the exam of choice as it is convenient, inexpensive, and fast, all of which are benefits gained when using the VMS.
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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.