SEATTLE, WASHINGTON--(Marketwire - July 17, 2012) - VentriPoint Diagnostics Ltd (TSX VENTURE:VPT) (OTCQX:VPTDF) announces the Children's Hospital of Colorado, The Children's Hospital of Philadelphia (CHOP), and The Hospital for Sick Children (SickKids) in Toronto have joined the multi-centre clinical trial studying the most common form of congenital heart disease, Tetralogy of Fallot or Blue-Baby Syndrome.
"We are very excited to be installing the VentriPoint Diagnostic System in our echocardiography lab in the Heart Institute at Children's Hospital Colorado and to be participating in the FDA trial. We feel this system has the potential to tremendously impact how we manage our patients with heart disease and we look forward to putting this system into everyday use", stated Dr. Bruce (Biff) F. Landeck II, assistant professor of pediatric cardiology.
The Tetralogy of Fallot clinical trial is designed to show substantial equivalency between the gold-standard MRI method, and the 2D-ultrasound VMS™ technique. Based on advice from the FDA, the study has been designed to collect images at multiple sites and to analyze them at core labs. Nationwide Children's Hospital in Columbus Ohio is the lead center for the study and the MRI core lab and the University of Nebraska has been announced as a second image-collection site. Along with the three new image-collection sites, we are also announcing SickKids will be the core lab for the VMS analysis.
To date, with only two centres, the study has enrolled 40 patients in the clinical trial, which is designed to complete 75 evaluable cases. With five centres now enrolling, the study is expected to be completed and submitted to the FDA in 3Q12 in support of regulatory approval through a 510(k) process by the end of the year.
"Enrollment has been slow as patients are reluctant to have an MRI for research purposes. Only one out of twenty patients approached agrees to volunteer. In addition, it takes several weeks to schedule the MRI," stated Dr. George Adams, CEO of VentriPoint, "This clinical experience reinforces the need for the VMS™ approach, which takes 5 minutes of patient time compared to over an hour in the MRI and can be done immediately by a sonographer without the need for patient sedation."
The VMS™ is for investigational use only in the United States and is approved for clinical use in Canada and Europe.
About Children's Hospital Colorado
Children's Hospital Colorado has defined and delivered pediatric healthcare excellence for more than 100 years. Founded in 1908, Children's Colorado is a leading not-for-profit pediatric network entirely devoted to the health and well-being of children. Continually recognized as one of the nation's outstanding hospitals by U.S. News & World Report and ranked fifth in their Best Children's Hospitals 2011-12 Honor Roll, Children's Colorado is known both for its nationally and internationally recognized medical, research and education programs as well as the full spectrum of everyday care for kids throughout Colorado and surrounding states. Children's Hospital Colorado Heart Institute is an international leader in pediatric cardiac care. It is one of only eight stand-alone pediatric research centers in the nation and one of the fastest-growing pediatric cardiac programs in the country. With more than 1,000 healthcare professionals representing the full spectrum of pediatric specialties, the network for Children's Colorado includes 15 regional locations including its main campus on the Anschutz Medical Campus, and more than 400 outreach clinics throughout Colorado and Wyoming.
For more information, visit www.childrenscolorado.org and connect with Children's Colorado on Facebook (www.facebook.com/childrenshospitalcolorado) and Twitter (www.twitter.com/ChildrensColo).
About The Children's Hospital of Philadelphia
Since its start in 1855 as the first hospital in the United States devoted exclusively to caring for children, The Children's Hospital of Philadelphia has been the birthplace for many dramatic firsts in pediatric medicine. The Hospital has fostered medical discoveries and innovations that have improved pediatric healthcare and saved countless children's lives. The Children's Hospital of Philadelphia was ranked No. 1 in more specialties than any other pediatric hospital in the United States, earning it top honors in U.S. News & World Report's 2012-13 survey of Best Children's Hospitals. The Cardiac Centre performs more than 50,000 diagnostic tests per year, including electrocardiograms, echocardiograms and cardiac MRI, for expert diagnosis and ongoing treatment of congenital heart disease.
About The Hospital for Sick Children
The Hospital for Sick Children (SickKids) is recognized as one of the world's foremost pediatric health-care institutions and is Canada's leading centre dedicated to advancing children's health through the integration of patient care, research and education. Founded in 1875 and affiliated with the University of Toronto, SickKids is one of Canada's most research-intensive hospitals and has generated discoveries that have helped children globally. Its mission is to provide the best in complex and specialized family-centered care; pioneer scientific and clinical advancements; share expertise; foster an academic environment that nurtures health-care professionals; and champion an accessible, comprehensive and sustainable child health system. SickKids is proud of its vision of Healthier Children. A Better World.™ For more information, please visit www.sickkids.ca.
The Labatt Family Heart Centre brings together significant interdisciplinary and interprofessional activities within Pediatric Cardiology, Cardiovascular Surgery, Cardiac Critical Care, Cardiovascular Research and Adult Congenital Heart Disease programs, thus allowing the Heart Centre to address the needs of patients and families from fetal life through to adulthood.
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 is the first application in a suite of applications for all major heart diseases including pulmonary hypertension, 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™ diagnostic tool and is pursuing the US-FDA approval through the 510(k) process.
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