SEATTLE, WASHINGTON -- (Marketwire) -- 02/19/13 -- VentriPoint Diagnostics (TSX VENTURE: VPT)(OTCQX: VPTDF) is providing a status report on its 2D echocardiographic (2DE) products, clinical research and regulatory submission plans.
VentriPoint is pleased to announce completion of its right ventricle (RV) database. Until now, databases have been disease specific, covering Pulmonary Artery Hypertension (PAH), Tetrology of Fallot (TOF) or dextro-Transposition of the Great Arteries (d-TGA). This new normal and RV database (NRV) allows clinicians to rapidly and accurately assess the status of the right ventricle in all patients that do not have significant congenital heart defects or PAH, yet may have a variety of other conditions, such as left-heart failure or valve disease. It is estimated that 27 million people have some form of heart disease and the addition of this database to the VMS heart analysis systems will provide a direct avenue for clinicians to better evaluate and care for these individuals.
The NRV database will be used with the VMS-2DE heart analysis system for patients where knowledge of the function of the right heart would be useful in assessing the overall heart function and optimally treat the patient. It can also be used to provide a reference baseline study for patients at risk for developing right heart dysfunction and would benefit from regular monitoring. The 2DE-NRV application is undergoing clinical evaluation in Europe and the Company intends to submit for European CE Mark and Health Canada approvals in the next 30 days.
The Company is discussing clinical research projects with its existing 26 users and other leading cardiac centers worldwide to study the 2DE-NRV application in as many heart conditions as possible.
New VMS Model Extends Care to Patient's Bedside for European and Canadian Hospitals
The Company has completed testing of the latest version of its VMS hardware technology, which was demonstrated at EuroEcho a few months ago. The new version works with conventional hospital beds and will allow the VMS to be used outside of the traditional echo laboratory any place in the hospital in a similar to conventional 2DE. This new device will greatly impact the number of patients that can benefit from the use of the VMS-2DE by allowing it to be used at the patient's bedside and alleviating the need to transfer critically-ill patients to the echo suite or MRI facility. This mobility should further lower the cost of right heart analysis and increase convenience over current practices. The Company expects to start shipping the newer VMS model in March and has already scheduled the first three installations. The Company will also offer a retrofitting service to existing users and will immediately contact all 26 existing users to determine if they wish to upgrade to the enhanced VMS-2DE system.
Ongoing Research and New Applications
The clinical trial in patients with Tetralogy of Fallot to support a 510(k) submission to the FDA is nearing completion with 9 new studies completed in the last 5 weeks. The trial has obtained 70 out of the 75 evaluable cases required for completion. The Company is preparing to train the core labs to conduct the MRI and VMS analyses in anticipation of full enrollment in the next few weeks. The analysis is expected to take 4-8 weeks.
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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