GROWING BODY OF RESEARCH INTO CARDIAC BIOMARKER ST2
OFFERS GREAT PROMISE IN THE CARE OF HEART FAILURE AND HEART ATTACK PATIENTS

New York, NY - -(Business Wire) - - April 15, 2008 - - Critical Diagnostics today announces the publication of two important research papers further refining the clinical value and mortality prediction power of the cardiac biomarker ST2.  On April 1, 2008 the research paper, “Increased Plasma Concentrations of Soluble ST2 are Predictive for 1-Year Mortality in Patients with Acute Destabilized Heart Failure” was published in the journal Clinical Chemistry, (www.aacc.org), and on April 15, 2008 the research paper “Complementary Roles for Biomarkers of Biomechanical Strain ST2 and N-Terminal Prohormone B-Type Natriuretic Peptide in Patients with ST-Elevation Myocardial Infarction” was published in the journal Circulation, (http://circ.ahajournals.org). The result of these latest studies is to confirm the clinical value of ST2 in the two cardiovascular diseases impacting the most patients, acute destabilized heart failure (ADHF) and myocardial infarction (MI).

The April 1 paper describing the prognostic strength of ST2 in patients diagnosed with ADHF provides an independent validation of the work published in August of 2007 in The Journal of the College of Cardiology, “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 just-published study analyzed a cohort of 137 patients diagnosed with ADHF from a total population of 251 patients who presented with dyspnea. This study unequivocally establishes that ST2 independently predicts mortality and provides the most accurate prediction of mortality, exceeding the mortality predictive values of natriuretic peptide biomarkers, such as BNP. First author on this paper, Dr. Thomas Mueller of the Konventhospital Barmherzige Brueder in Linz, Austria adds, "It can be derived from our data that ST2 seems to be an excellent marker for risk stratification in patients with acute destabilized heart failure providing prognostic information being stronger than other traditional risk factors, such as age or renal dysfunction. Thus, ST2 determination might offer significant value in helping physicians in cardiac patient care in the emergency department." 

The second paper, produced by the TIMI Study Group at Brigham and Women’s Hospital in Boston, analyzed a large cohort of 1239 patients with STEMI who underwent coronary angiography. This study concluded that in contrast to NT-proBNP the baseline level of ST2 strongly predicted risk of cardiovascular death or heart failure and was independent of clinical factors potentially related to increased left ventricular wall stress, such as age, hypertension, prior MI and prior heart failure. Lead author of this paper, Dr. Marc Sabatine comments, “Measurement of ST2 provides significantly improved risk prediction in patients with acute myocardial infarction, beyond traditional clinical risk factors and existing biomarkers such as NT-proBNP.” The study went on to report that, as had been observed in earlier studies, although NT-proBNP and ST2 are independent biomarkers for prediction of mortality there is a complementary value in using the markers together.    

Cardiovascular disease is the leading cause of death in the US and the incidence of heart failure, as a form of cardiovascular disease, is increasing. The research described in these papers confirms that ST2, which is a mechanically-induced cardiovascular protein, is a powerful and accurate biomarker for prediction of near term mortality in ADHF as well as MI patients. “Determination of disease severity in patients with acute cardiovascular disease, such as heart failure or myocardial infarction, is particularly challenging for physicians with the tools available to them today,” comments Critical Diagnostics President James V. Snider, Ph.D. adding, “The results described in these research papers confirm the potential clinical value of ST2 as a risk stratification and disease severity determination biomarker for patients with cardiovascular disease.”  

About Critical Diagnostics
Critical Diagnostics is the exclusive developer of the Presage™ laboratory assays employing ST2 for the diagnosis and prognosis of cardiovascular disease.¹ 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.

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.

LEADING EXPERTS PRAISE CARDIAC BIOMARKER ST2
Biomarker Shows Promise For Improving Patient Outcomes and Reducing Costs

New York, NY - - January 2, 2008 - - Critical Diagnostics today announced publication of a key opinion article describing the utility of the cardiac biomarker ST2 for assessing cardiac risk in the emergency department. The article, published in the College of American Pathologists journal CAP Today is titled “ST2 in the ED: Will it nail cardiac risk.” The article summarizes the opinion and experience of an international group of key thought leaders in the utilization of biomarkers in the application of emergency medicine and cardiology. The consensus is that, although still at an early stage of development, the ST2 assay shows great promise as a valuable tool in treating patients who are diagnosed with cardiovascular disease or who present with symptoms of cardiovascular disease.

Contributing to the article were Robert H. Christenson, Ph.D. (Director of Core Laboratories at the University of Maryland Medical Center and Professor of Pathology and of Medical Research and Technology, University of Maryland School of Medicine), James L. Januzzi, MD (Associate Professor of Medicine at Harvard University, and Clinical Director of the Cardiac Intensive Care Unit at Massachusetts General Hospital), 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), Jordi Ordonez-Llanos, MD, Ph.D. (Professor of Clinical Biochemistry at Hospital Santa Creu I Sant Paul in Barcelona), W. Frank Peacock, MD (Vice Chief of Emergency Medicine at the Cleveland Clinic), and Richard L. Summers, MD (Professor of Emergency Medicine at the University of Mississippi Medical Center, Oxford).

“Researchers around the world have recognized the importance of this (ST2) marker in each study, and the consistency of results is really remarkable,” says Dr. Januzzi. Speaking of the evolution in cardiac markers, Dr. Christenson comments, “Everybody in this field is searching for that Holy Grail, a marker that will not only predict risk but also may be key to treatment…Then ST2 comes along and, consistently in trials for not only heart failure but also for acute coronary syndrome, it’s a better predictor of death…This is a marker that people will actually see become useful in laboratories in the next few years.” Dr. Peacock echoes some of the same sentiments. “ST2 could also work on acute coronary syndrome as well as heart failure,” adding, “...it’s a ‘this-dude-is-sick’ marker that’s extremely valuable in the emergency department.”

“It’s very consistent,” says Dr. Christenson, “If you come into the ER with shortness of breathe, and you have a value of ST2 greater than .2ng/ml., then you’re a high-risk patient.” According to the article’s author, Anne Paxton, “Christenson believes ST2 may be an even broader marker than BNP or NT-proBNP.” “While we think naturetic peptides are very useful, they are not perfect,” says Dr. Januzzi, adding, “…to have another cardiac biomarker with profound value to assist naturetic peptides testing in evaluating the acutely dyspneic patient – with or without heart failure – would be welcome. We may have found it,” “What ST2 adds is a much sharper risk assessment,” according to Dr. Peacock. “BNP won’t identify all the people who do worse. ST2 identifies more, so it’s a better prognostic tool. It’s a great discriminator.”

In addition to the previously published results describing the utility of ST2 in assessing the risk of mortality in patients presenting with symptoms of heart failure recent research results extend this to include patient monitoring. Alan Maisel, MD and Rob Fitzgerald, Ph.D. at the University of California, San Diego, have reported results from a cohort of patients hospitalized for acute decompensated heart failure showing that ST2 is a stronger prognostic indicator than natriuretic peptides. The conclusion from this study is that those patients whose ST2 levels remained high during treatment had a higher likelihood of mortality, irrespective of their BNP levels. In fact, among those patients destined to die, BNP levels often trended downward, while the ST2 concentrations did not. “So the take-home message – since we’re lately focusing on BNP as a tool to identify those patients not responding to medical therapy – is that ST2 may be superior for this indication” according to Dr. Januzzi. Expanding on the description of the utility that ST2 shows for patient monitoring Dr. Ordonez, describes results from analysis of an ADHF outpatient cohort. Dr. Ordonez comments, “ST2 was predictive of events in this population with long-term followup, even stronger than NT-proBNP.” 

 “Effectively managing and treating patients presenting with symptoms of cardiovascular disease is particularly challenging for emergency department physicians with the tools available to them today. And it doesn’t get any easier after admission or during outpatient monitoring. Our research results, as described by these key thought leaders and published in major journals, indicate that ST2 is a novel cardiac biomarker that, in these applications, is superior to the existing gold standard biomarkers for cardiovascular disease, troponin and natriuretic peptides. As a cardiovascular risk stratification and disease severity determination biomarker ST2 has the potential to significantly improve the delivery of patient care and lower overall cost.” comments Critical Diagnostics President James V. Snider, Ph.D., adding, “The body of evidence supporting the clinical value of ST2 is growing as several additional research studies have been completed with results being prepared for publication and new studies are being initiated.”  

The complete CAP Today article is available online at www.cap.org or can be downloaded from the company website at www.criticaldiagnostics.com, by clicking here.

About Critical Diagnostics
Critical Diagnostics is the exclusive developer of the Presage™ laboratory assays employing ST2 for the diagnosis and prognosis of cardiovascular disease.¹ 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.

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.

Cardiac Biomarker Shows Great Promise
Milestone Study Reveals Mortality Prediction Power of ST2 in Dyspneic Patients

New York, NY - - (BUSINESS WIRE) - - August 7, 2007 - - 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.”

About Critical Diagnostics
Critical Diagnostics (www.criticaldiagnostics.com) is the exclusive developer of the Presage™ 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.

Critical Diagnostics Strengthens Leadership Team
Veteran Industry Executive Named President

NEW YORK, NY, August 11, 2005 - Critical Diagnostics, an early-stage healthcare company dedicated to the development of an important new category of diagnostic and prognostic markers that are useful both for the early detection and guiding therapy of both myocardial infarction (heart attack) and heart failure, announced that Dr. James Snider has joined the organization as President.

Prior to joining Critical Diagnostics, Dr. Snider spent over three years as the Executive Vice President of Business & Operations for IntelligentMD ("IMD"), an early-stage medical device company that focuses on the essential elements of disease diagnostics and therapeutic intervention. While at IMD he guided the company through three rounds of fundraising, staffing and resourcing for two product development projects and several business development deals. Prior to joining IMD, Dr. Snider spent eight years in a series of marketing and product development positions at Applied Biosystems (ABI).

Before his tenure at ABI, Dr. Snider was a Senior Scientist at Biotech Research Laboratories, a contracts and service research company specializing in retroviral technologies. Dr. Snider performed his post-doctoral research as a fellow in the Biological Response Modifiers Program at the Frederick Cancer Research & Development Center of the National Cancer Institute. He holds a BS in chemistry from Grand Valley State University, a Ph.D. in chemistry from the University of South Carolina and an MBA in technology management from the University of Phoenix.

For More Information
For more information, please email jsnider@criticaldiagnostics.com

Critical Diagnostic Secures Seed Financing
Company Has Test to Quickly Determine Heart Attacks

NEW YORK, NY October 18th, 2004 - Critical Diagnostic, an early stage healthcare company dedicated to the development of an important new category of diagnostic tests that are useful for both early detection of myocardial infarction, commonly referred to as a heart attack, and in crucial patient monitoring during treatment of myocardial infarction and heart failure, announced that it has closed a seed round of financing provided by Carrot Capital Healthcare Ventures. The size of the round was not disclosed.

Cardiovascular disease, despite all the recent medical advances -- such as coronary artery bypass grafting and drug-eluting coronary artery stents -- remains the leading cause of death in America. Emergency physicians, who are challenged to quickly and accurately evaluate heart attack-like symptoms common to a variety of diseases or conditions -- shortness of breath, numbness in the arms and legs, chest pain, dizziness, among others -- need quick, accurate answers. It is expected that with the introduction of Critical Diagnostic’s tests, physicians will be greatly aided in making these life-saving medical decisions within the first critical hour of the onset of symptoms on whether a patient is having a heart attack, the level of severity of the attack and its likely course, thereby improving the overall quality of patient care and contributing to cost-effective medical treatment.

Critical Diagnostic’s novel and advanced technology was created by noted molecular biologist Dr. Richard Lee, Associate Professor of Medicine at Brigham and Women’s Hospital and Harvard Medical School, and uses intellectual property licensed from Brigham and Women’s Hospital, Boston.

Initial funding for Critical Diagnostics was provided by Carrot Capital Healthcare Ventures (CCHV), a seed/early-stage fund that invests in opportunities across the healthcare sectors, including pharmaceuticals, diagnostics, medical devices, instrumentation, healthcare services and medical information systems.

CCHV is part of Carrot Capital, a New York City-based venture capital group. CCHV’s mission is to help healthcare entrepreneurs accelerate their business development, compress critical milestones, build high caliber management teams, and create successful enterprises. The fund has a two-fold investment strategy: to serve as lead investors in seed and early stage healthcare companies, and to license and commercialize healthcare technology from universities and research institutions.