The Company continues to support a number of research projects to further validate the VMS-2DE product as well as develop new applications. For example, the Manchester Heart Centre in the UK is evaluating patients with TOF as well as patients with pulmonary stenosis, while the Seattle Children's Hospital is studying all patients undergoing a clinically-indicated cardiac MRI regardless of heart defect, to determine the overall benefit of the 2DE product in children.
The Company has initiated preliminary clinical work to assess the utility of the VMS to help physicians to better care for patients with Ventricular Assist Devices (VADs) or artificial hearts. These devices are temporarily implanted to allow a patient's heart to recover from massive heart attacks, bypass surgery or other causes of heart failure and sometimes as a bridge to a heart transplant for a chronically-failing heart. Physicians need to better understand how the right heart is functioning to determine when a patient is ready to have the assist device removed or if a heart transplant is needed.
The Company has started an investigational project to assess using the magnetic tracking system with pacemakers or other implantable heart devices, a current contra-indication to use. Several sites have indicated that they have used our device with pacemakers without adverse affects, however clinical research is required to validate the safety of the magnetic tracking apparatus on heart devices. The Company is facilitating research that will demonstrate the VMS-2DE can be used on patients with such devices and expects to have conference presentations this year.
In other developments, the University of Chicago has decided to expand the PAH pilot clinical study into a multicentre study and include the Krankenhaus der Elisabethinen Hospital in Austria. The University of Chicago will be presenting its latest PAH results at the American Cardiology Congress in March in San Francisco.
The VMS-2DE is approved for clinical use in TOF, dextro-Transposition of the Great Arteries (d-TGA) and 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 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 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
VentriPoint Diagnostics Ltd.
Dr. George Adams, CEO
(206) 283-0221, ext. 401
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