

VentriPoint VMS(TM) Heart Analysis System Installed at the Prestigious Baylor Heart Clinic in Houston
July 10, 2012 07:00 ET
VentriPoint VMS™ Heart Analysis System Installed at the Prestigious Baylor Heart Clinic in Houston
Patients Enrolled in Pulmonary Arterial Hypertension Clinical Trial
SEATTLE, WASHINGTON--(Marketwire - July 10, 2012) - VentriPoint Diagnostics Ltd. (TSX VENTURE:VPT) (OTCQX:VPTDF) has installed its VMS™ heart analysis system at the Baylor Heart Clinic at Baylor College of Medicine (BCM) in Houston. Physicians at BCM will use the device to support VentriPoint's clinical trials program and for other research purposes.
"Current echocardiographic evaluation of the right ventricle (RV) of the heart is largely based on a doctor's subjective evaluation and other semi-quantitative methods which are often difficult to replicate especially in patients with enlarged RVs. In the case of Pulmonary Arterial Hypertension (PAH), in addition to evaluation of the pulmonary artery pressures, evaluation of the size and function of the RV is key to making many difficult clinical decisions regarding initiation and monitoring responses to specific treatments," stated Dr. Basant Arya, Assistant Professor of Medicine-Cardiology and Medical Director, Echocardiography and Nuclear Cardiology, Division of Cardiology, Baylor Heart Clinic.
"With its ability to reconstruct an accurate 3D model of the RV from the 2D images, the VMS™ is an important tool to quantitatively evaluate the RV volumes and systolic function. Early experience with this technology to evaluate pediatric patients with congenital heart disease has provided consistent results with MRI data. As one of the major sites for VentriPoint's study of adults with PAH, the ease of image processing and the speed of reconstruction of the 3D volumes by the VMS™ are important. Establishing the reproducibility and correlation of the RV volumes and ejection fraction as evaluated by VMS™, with MRI data will enable more accurate, reproducible and quantitative evaluation of the RV function by echocardiography," continued Dr. Arya.
"Baylor College of Medicine is world renowned for its heart program and we are delighted to have the VMS™ fully operational," said Dr. George Adams, CEO of VentriPoint. "They have already enrolled their first four patients in the multi-centre clinical trial in PAH and are on a pace to complete their portion of the trial on schedule."
The Company's expectation is the results of this multi-centre clinical study will be satisfactory and supportive of a 510(k) submission to the US FDA. The study will compare the functional heart information obtained by VMS™ ultrasound and cardiac MRI in 75 patients with PAH. All sites are now operational and to date 19 cases have been completed. The study is expected to be complete for submission in 3Q12 and a response from FDA within the mandatory 90 days, which would be by the end of the year.
PAH, the most serious form of the five recognized groups of pulmonary hypertension is a devastating disease, and if left untreated has an average patient lifespan of less than 3 years after diagnosis. It affects individuals from infancy to the elderly. It is widely known that PAH patients detected early in the disease's progression have better results than patients that start therapy later.
The VMS™ is for investigational use only in the United States and is approved for sale and clinical use in Canada and Europe.
About The Baylor Heart Clinic
Baylor Heart Clinic expert cardiologists practice a collaborative approach to healthcare. They provide an evidence-based treatment plan that addresses existing heart concerns and helps modify risk factors for a lifetime of optimal cardiac health. Patients benefit from the latest in emerging therapeutics and technologies. Baylor College of Medicine also enjoys a unique affiliation with the Texas Heart Institute (THI)-an institution ranked among the nation's top 10 heart centers by U.S. News and World Report. Baylor College of Medicine ([ www.bcm.edu ]) in Houston is recognized as a premier academic health science center and is known for excellence in education, research and patient care. It is the only private medical school in the greater southwest and is ranked as one of the top 25 medical schools for research in U.S. News & World Report. BCM is listed 13th among all U.S. medical schools for National Institutes of Health funding, and 2nd in the U.S. in federal funding for research and development in the biological sciences at universities and colleges by the U.S. National Science Foundation. Follow Baylor College of Medicine on Facebook ([ http://www.facebook.com/BaylorCollegeOfMedicine ]) and Twitter ([ http://twitter.com/BCMHouston ]).
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. Management believes the VMS™ is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. Congenital heart disease is the first application in a suite of applications for all major heart diseases including pulmonary hypertension, cardiovascular disease and heart failure, which management believes has a multibillion-dollar market potential. Canada and Europe (CE Mark) have granted approval for the sale of VentriPoint's VMS™ heart analysis system and VentriPoint is pursuing the US-FDA approval through the 510(k) process.
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