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.
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