October 01, 2016 11:03 AM ET

Healthcare Providers and Services

Company Overview of Critical Care Diagnostics Inc.

Company Overview

Critical Care Diagnostics, Inc. develops laboratory assays for the cardiovascular diseases. It offers Presage, a laboratory assay employing ST2 for the diagnosis and prognosis of cardiovascular disease. The company also offers Aspect-PLUS ST2 test, a cardiac biomarker testing product that aids clinicians in assessing risk, making treatment decisions, evaluating therapy effectiveness, and monitoring patient care. Critical Diagnostics was incorporated in 2004 and is based in New York, New York.

802 6th Avenue

Suite 63

New York, NY 10001

United States

Founded in 2004

Phone:

925-399-5035

Fax:

866-715-8009

Key Executives for Critical Care Diagnostics Inc.

Founder, Chairman, Chairman of the Management Board and Chief Executive Officer
President and Member of the Management Board
Vice President of Operations & Global Marketing
Senior Vice President of International Sales and Business
Director of Critical Diagnostics and Member of the Management Board
Compensation as of Fiscal Year 2016.

Critical Care Diagnostics Inc. Key Developments

Critical Diagnostics Inks Exclusive Worldwide License Agreement for New Heart Failure Biomarker sNEP with Health Sciences Research Institute Germans Trias i Pujol Foundation

Critical Diagnostics entered into a license agreement for the exclusive worldwide rights to the use of the biomarker soluble neprilysin (sNEP) in the diagnosis and monitoring of heart failure patients. Health Sciences Research Institute Germans Trias i Pujol Foundation (IGTP) of Barcelona Spain is the licensor. The neprilysin inhibitor Sacubitril is a key ingredient in a new heart failure drug, Entresto® marketed by Novartis. Entresto1 is FDA approved in the United States and EC approved in Europe.

Critical Diagnostics Announces Executive Changes

Critical Diagnostics announced two promotions within the company’s management team. Dennis Dalangin, formerly Vice President, Global Marketing has been promoted to Vice President, Operations and Global Marketing, and Greg Cerra, formerly Director, Regulatory Affairs has been promoted to Vice President, Regulatory Affairs and Quality Systems. Mr. Dalangin joined Critical Diagnostics in 2012 as the Vice President of Global Marketing, and, in his newly expanded role as Vice President, Operations and Global Marketing will now also be responsible for the day to day management of the operations at the San Diego headquarters, which include three contract manufacturers, and a logistics fulfillment partner in Europe and US. Mr. Cerra joined Critical Diagnostics in 2015 as the Director, Regulatory Affairs, and was instrumental in the company’s efforts to CE Mark its next generation platform, ASPECT-PLUS, a new rapid ST2 test. With his promotion to Vice President, Regulatory Affairs and Quality Systems, Mr. Cerra will be responsible for the global strategy and efforts surrounding the registration and clearance of the company’s products in key markets.

China Food and Drug Administration Clears Critical Diagnostics's Presage ST2 Assay for Clinical Use

Critical Diagnostics announced that the China Food and Drug Administration (CFDA) has cleared the Presage ST2 Assay for clinical use. This follows news that ST2 has been included in the coveted Chinese Heart Failure Guidelines. In a rigorous multivariate analysis involving over 1,500 Chinese heart failure patients, those with the high levels of ST2 were at over 5 times the risk for all-cause death or cardiac transplantation within 30 days, in comparison to patients with the lowest ST2 levels. Moreover, ST2 levels were significantly elevated among patients with adverse events across all time periods examined over a 3-year follow up period. ST2 is a soluble protein expressed by the heart in response to disease or injury. It is reflective of ventricular remodeling and cardiac fibrosis associated with heart failure. ST2 is not adversely affected by confounding factors such as age, body mass index and impaired renal function. Unlike many other cardiac biomarkers, ST2 levels change quickly in response to changes in the patient’s condition—thus helping physicians make informed decisions on an appropriate course of action to take and, if needed, to quickly adjust care.

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