SEATTLE, WASHINGTON--(Marketwire - Dec. 10, 2009) - VentriPoint Diagnostics Ltd. ("VentriPoint" or the "Corporation") (TSX VENTURE:VPT) is pleased to announce that it has received approval to CE Mark its VentriPoint Medical System (VMS) which generates critical heart measurements from 2D ultrasounds in a rapid, accurate and inexpensive manner not currently available. Rapid and accurate right ventricle measurements is essential for assessment of patients with cardiovascular disease. As reported in a recent Journal of American Heart Association, Circulation, and confirmed in other publications, …"many studies have demonstrated the prognostic value of RV function in cardiovascular disease".
The CE Mark enables VentriPoint to sell its VentriPoint Medical System broadly around the globe. The device has already received Health Canada clearance and the submission to the FDA for US approval was recently filed.
"Accomplishing CE Mark approval is the latest step in what continues to be the steady advance toward commercializing our VentriPoint Medical System," said Joseph Ashley, CEO of VentriPoint. "It's also an important milestone in our strategy for reaching the worldwide market for critical heart monitoring, which is estimated to be more than $5 billion annually. We are encouraged by our progress and look forward to announcing other achievements in the near future."
Mr. Ashley said that efforts to commercialize the VentriPoint Medical System in Europe will benefit from having three highly esteemed European investigators as co-authors of the recently announced manuscript accepted for publication by the peer reviewed American Journal of Cardiology. The Manuscript presented the exceptionally accurate and reproducible results of a multinational clinical validation study of the VentriPoint Medical System's Knowledge Based Reconstruction. The results agreed closely with true values for end-diastolic volume (r=0.993), end-systolic volume (r=0.992), and ejection fraction (EF; r=0.930). By using information produced from currently deployed 2D ultrasounds which are ubiquitous around the world, the VentriPoint Medical System will provide these critical results to medical professionals for less than $100/ study as compared to the expenditure of multiple $100 thousands for a new 3D ultrasound with recently published accuracies of 0.93, 0.92 and 0.72 (ED, ES and EF) or the even more expensive MRIs.
VentriPoint creates diagnostic tools to monitor patients with heart disease – the number one cause of death in developed countries. By using images produced from existing medical imaging systems, the VentriPoint Medical System ("VMS") generates critical heart measurements in a rapid, accurate and inexpensive manner not currently available. Health Canada and Europe have granted licensed approval for the VMS breakthrough diagnostic tool which is based upon technology received by VentriPoint through its exclusive technology license with the University of Washington. The VMS, together with its associated online service, is being developed for a variety of heart related disease states, including congenital heart disease and pulmonary hypertension.