Cardiac Biomarker Shows Great Promise, Announces Critical Diagnostics.

Milestone Study Reveals Mortality Prediction Power of ST2 in Dyspneic Patients

NEW YORK -- Critical Diagnostics today announced that a pivotal research paper has been published in The Journal of the College of Cardiology (www.onlinejacc.org), titled, "Measurement of the Interleukin Family Member ST2 in Patients with Acute Dyspnea: Results from the ProBNP Investigation of Dyspnea in the Emergency Department (PRIDE) Study." The results of the study clearly demonstrate the strength of ST2 as a biomarker for risk stratification and prediction of mortality in patients who present to the emergency department with shortness of breath and suspected acute decompensated heart failure, according to lead researcher and author Dr. James L. Januzzi.

Dr. Januzzi, Associate Professor of Medicine at Harvard Medical School, and Physician in the Division of Cardiology at the Massachusetts General Hospital where he is also the Chief of the Coronary Care Unit, declared "Even in the presence of many established predictors of risk, ST2 provided remarkable prognostic information that frequently was stronger than other traditional risk factors, such as age or renal function. Furthermore, ST2 provided prognostic information that was at least as powerful, if not more so, as that from natriuretic peptide testing, the current 'gold standard' for predicting outcomes among patients with heart failure. We are very excited to continue working with ST2, as this promising assay appears to be the one of the best candidates among new heart failure biomarkers."

Cardiovascular disease is the leading cause of death in the US and incidence of heart failure, as a form of cardiovascular disease, is increasing. There are currently over five million Americans living with heart failure with another 500,000 new diagnoses each year. ST2 is a mechanically-induced cardiomyocyte protein, and serum levels of ST2 have been shown to predict outcome in patients with acute myocardial infarction or heart failure. The research described in this paper illustrates that ST2 is a powerful biomarker for prediction of near term mortality in dyspneic as well as acute decompensated heart failure patients. "Determination of disease severity in patients with symptoms of heart failure or who are diagnosed with heart failure is particularly challenging for physicians with the tools available to them today. We are very excited about these results and the potential utility of ST2 as a risk stratification and disease severity determination biomarker," comments Critical Diagnostics President James V. Snider, Ph.D., adding, "other ST2 studies in progress are expected to yield confirmatory as well as new clinically-useful results, which should lead to several other publications and additional excitement about the prospects of ST2."

About Critical Diagnostics

Critical Diagnostics (www.criticaldiagnostics.com) is the exclusive developer of the Presage[TM] laboratory assays employing ST2 for the diagnosis and prognosis of cardiovascular disease1. Critical Diagnostics was founded in 2004 and is funded by Carrot Capital Healthcare Ventures (CCHV) of New York. CCHV focuses on promising seed- and early-stage investment opportunities across a broad spectrum of the healthcare industry.

The company is currently managed by James V. Snider, Ph.D., as President, and a board of directors comprised of CCHV principals. Management is supported by a world class Scientific Advisory Board and retained consultants who actively participate in development of this essential technology. Members of the Scientific Advisory Board include Dr. Januzzi, as well as, in alphabetical order; Donna J. Edmonds, COO of Vital Sensors, Inc., Robert L. Jesse, MD, Ph.D., Director of Acute Cardiac Care for Virginia Commonwealth University Health System, Chairman of the Cardiology Division at the Veteran Affairs Medical Center in Richmond, and National Program Director for Cardiology for the Veterans Health Administration in Washington, DC., Alan Stewart Maisel, MD, Professor of Medicine at the University of California, San Diego as well as the Director of the Coronary Care Unit and Heart Failure Program at the VA Medical Center in La Jolla, CA, David A. Morrow, MD, MPH, Associate Physician in the Division of Cardiovascular Medicine at Brigham and Women's Hospital, Boston, MA, William Franklin Peacock IV, MD, FACEP, Vice Chief of Emergency Medicine at The Cleveland Clinic, Cleveland, OH and is also an Associate Professor at The Ohio State University, and Alan Wu, Ph.D., D.A.B.C.C. Chief of Clinical Chemistry and Toxicology at San Francisco General Hospital and Professor of Laboratory Medicine, University of California, San Francisco.

1Presage and assays employing ST2 are not currently approved by the FDA for clinical use and are not available for sale in the US for clinical use.