Children's Hospital &; Medical Center in Omaha Joins VentriPoint Congenital Heart Disease Clinical Trial
November 30, 2011 19:14 ET
Children's Hospital & Medical Center in Omaha Joins VentriPoint Congenital Heart Disease Clinical Trial
Dr. Shelby Kutty will be the Principal Investigator for the Trial in Omaha
SEATTLE, WASHINGTON--(Marketwire - Nov. 30, 2011) - VentriPoint Diagnostics (TSX VENTURE:VPT) (PINK SHEETS:VPTDF) today announced that the Children's Hospital & Medical Center in Omaha, Nebraska has joined the clinical trial to validate VentriPoint's VMS™ 3D imaging technology in patients with the most common form of congenital heart disease, Tetralogy of Fallot or Blue- Baby Syndrome.
"We are pleased to be collaborating with VentriPoint on this project," said Dr. Shelby Kutty, Children's pediatric cardiologist and Assistant Professor of Pediatrics and Radiology at the University of Nebraska Medical Center.
"The clinical trial is progressing and will now accelerate with the assistance of the team in Omaha," stated Dr. George Adams, CEO of VentriPoint. "With this trial, the company is positioning itself to become the standard of care for measuring right ventricular volumes in a manner that is cost-effective, timely, and accurate."
The Company received a letter from the FDA in response to its latest submission (submitted July, 2011) and the FDA suggested clarifications to the clinical trial design and statistical analysis plan, which the company is implementing. The Company is preparing a written response to the FDA's questions and will meet with the FDA on January 5, 2012 to review its regulatory submissions for approval of the VMS(tm) heart analysis system. The company expects the data from the current clinical trial will underpin a 510k submission to the FDA as soon as possible after the meeting.
About Children's Hospital & Medical Center, Omaha
Proudly serving children since 1948, Children's Hospital & Medical Center ([ www.ChildrensOmaha.org ]) is recognized as a 2011-12 Best Children's Hospital by U.S. News & World Report in cardiology and heart surgery, and orthopedics. It is the only full-service, pediatric health care center in Nebraska providing expertise in more than 30 pediatric specialty services to children across a five-state region and beyond. Located in Omaha, the 145-bed, non-profit hospital houses the only dedicated pediatric emergency department in the region and offers 24-hour, in-house services by pediatric critical care specialists.
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 multibillion 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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