VentriPoint Diagnostics Ltd.

VentriPoint Diagnostics Ltd.

November 01, 2011 07:00 ET

VentriPoint Commences Clinical Studies of Pulmonary Arterial Hypertension Application of Right Heart Analysis System

- The University of Chicago Completes First Patient -

SEATTLE, WASHINGTON--(Marketwire - Nov. 1, 2011) - VentriPoint Diagnostics (TSX VENTURE:VPT)(PINK SHEETS:VPTDF) announces the University of Chicago has secured a VentriPoint Medical System (VMS™) and has begun the clinical evaluation of the database for patients with Pulmonary Arterial Hypertension (PAH).

The study will be led by four highly regarded cardiac specialists from the University of Chicago; Dr. Roberto Lang, former President of the American Society of Echocardiography and Director of the Echo Lab; Dr. Mardi Gomberg, expert clinician and researcher in the field of pulmonary hypertension; Dr. Amit Patel, Director of Cardiac MRI; and Dr. Benjamin Freed, Lead Cardiologist.

"I expect that an assessment of RV volume and function using the VMS™ will become part of the routine clinical ultrasound evaluation for patients at risk for PAH," stated Dr. Roberto Lang. "A simple way to detect and monitor PAH is gravely needed and this methodology will be extremely useful to quantify interventions (therapeutic and surgical) performed on the right ventricle," Dr. Lang added.

It is anticipated this first clinical study will take four to six weeks and will verify the accuracy of the system in patients known to have PAH. If successful, a multicenter clinical trial will be initiated to compare VMS™ with MRI as part of a submission to the FDA as part of a 510K submission.

Dr. George Adams, VentriPoint President and CEO stated, "The Company will leverage the success of the VentriPoint technology with congenital heart disease to address the needs of a significantly larger population of patients at risk for pulmonary hypertension."

The VMS™ is for investigational use only in the United States and approved for clinical use in Canada and Europe.

About Roberto Lang, M.D.

Director, Professor of Medicine, University of Chicago Medical Center

Roberto M. Lang, MD, is an internationally renowned cardiologist and specialist in echocardiography. Dr. Lang uses his vast knowledge of cardiac imaging techniques to evaluate patients with a wide variety of heart conditions, including heart failure and valve disease. He is a past president of the American Society of Echocardiography.

About Mardi Gomberg-Maitland, MD

Director, Pulmonary Hypertension Program, University of Chicago Medical Center

Dr. Mardi Gomberg-Maitland is an expert clinician and researcher in the field of pulmonary heart disease. In recent years, she has participated in dozens of multi-center, multinational research trials to explore new therapies for pulmonary hypertension. She is a former Doris Duke Clinical Scientist winner. She is currently focusing on pulmonary arterial, pulmonary venous hypertension/diastolic dysfunction, and biomarker development.

Dr. Gomberg-Maitland has published numerous articles in leading medical journals, including the New England Journal of Medicine, the Journal of the American College of Cardiology, the American Journal of Respiratory and Critical Care Medicine, and the Archives of Internal Medicine.

About Amit Patel, MD

Director, Assistant Professor of Medicine, University of Chicago Medical Center

Dr. Amit Patel is a cardiologist who specializes in cardiac magnetic resonance imaging (CMR) and cardiac computed tomography (CT)--new, noninvasive techniques for evaluating diseases of the heart and coronary arteries. CMR and cardiac CT are important diagnostic tools that provide clinicians with detailed images of a beating heart and its blood vessels. Dr. Patel's research is focused on refining and expanding clinical applications of CMR and cardiac CT. He is particularly interested in using Command CT to perform stress testing of the heart.

About the University of Chicago Hospital

The University Of Chicago Medical Center (UCMC) has been at the forefront of medicine since opening in 1927. The hospital is a recognized leading cardiology institution. More than just a hospital, the UCMC consists of:

  • Bernard A. Mitchell Hospital, the primary adult inpatient care facility
  • Comer Children's Hospital for children at the University of Chicago
  • Chicago Lying-in Hospital, a maternity and women's hospital
  • Duchossois Center for Advanced Medicine, a state-of-the-art outpatient care facility
  • Outpatient locations throughout the Chicago area
  • University of Chicago Pritzker School of Medicine, one of the nation's premier medical schools

About Pulmonary Arterial Hypertension

Pulmonary arterial hypertension (PAH) is the most serious form of the five recognized groups of pulmonary hypertension. PAH is a devastating disease with an average patient lifespan of less than 3 years after diagnosis if untreated. It affects individuals of all ages from infancy to the elderly. Although treatment started early after detection appears more effective than when started later, the majority of patients with PAH continue to be diagnosed too late for treatment to be fully effective. PAH can occur for no known reason but will typically occur in association with many common conditions such as chronic liver disease and liver cirrhosis; connective tissue disorders such as scleroderma or systemic lupus erythematosus (lupus); congenital heart disease (even if repaired) and HIV. With increasing availability of effective therapies, and evidence-based treatment guidelines recommending starting treatment early, tests enabling detection as early as possible should prove invaluable.

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. The VMS™ is the first cost-effective and accurate diagnostic tool for measuring right ventricle heart function. Monitoring 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 - 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 US-FDA approval through the 510(k) process.

FORWARD-LOOKING STATEMENTS: The statements made in this press release that are not historical facts contain forward-looking information that involves risk and uncertainties. All statements, other than statements of historical facts, which address VentriPoint's expectations, should be considered forward-looking statements. Such statements are based on management's exercise of business judgment as well as assumptions made by and information currently available to management. When used in this document, the words "may", "will", "anticipate", "believe", "estimate", "expect", "intend" and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect a current view of future events and are subject to certain risks and uncertainties as contained in the Corporation's filings with Canadian securities regulatory authorities. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements. The Corporation undertakes no obligation, and does not intend, to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof, or to reflect the occurrence of any unanticipated events. Although management believes that expectations are based on reasonable assumptions, no assurance can be given that these expectations will materialize.

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