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Wednesday, February 16, 2011 2:07:49 PM
Study shows my3KG significantly improves sensitivity for
detection of myocardial infarction in diabetics
SANTA CLARA, CA (February 15, 2011) - PR Newswire - NewCardio, Inc., (OTC BB: NWCI) a cardiovascular diagnostic solutions developer, announced today that the Company has been invited by the American College of Cardiology (ACC) to present the results of a key study showing that NewCardio's urgent care solution, my3KG™, had substantially greater accuracy than expert cardiologists' interpretation of standard 12-lead ECG (12L ECG) in diagnosing Acute Myocardial Infarction (AMI) in diabetic patients. The presentation will be made at the 60th Annual ACC Scientific Meeting to be held in New Orleans, LA, April 2-5, 2011.
Accurate and timely diagnosis of AMI is notoriously difficult in diabetics, largely because the standard 12L ECG is often inaccurate, inconclusive or non-diagnostic in this patient group. To address this problem, investigators at the University of Kansas Medical Center, in collaboration with NewCardio physician-scientists, obtained detailed clinical and 12L ECG data on 155 consecutive diabetic patients with suspected AMI, and evaluated the diagnostic performance of my3KG in this patient group. The study, which was completed in October 2010, showed that my3KG had 42% greater sensitivity than expert cardiologist interpretation of 12L ECG for early detection of AMI, with equal or better specificity.
Diabetics with AMI represent a very large and growing patient group, and currently affect over 10% of adults in the US. Moreover, the incidence of AMI is two to four times greater in diabetics than in the general population, according to the American Diabetes Association and the American Heart Association. NewCardio believes use of my3KG in this patient group may facilitate more accurate and timely diagnosis of AMI in diabetic patients, and may lead to improved clinical outcomes.
Dr. Ihor Gussak, MD, PhD, NewCardio's Chief Medical Officer and a Fellow of the ACC, commented, "We are delighted to present our study results at this prominent and well-attended meeting. This professional cardiology forum provides us with a great opportunity to share exciting data from our most recent clinical study, which shows that the my3KG can substantially improve diagnosis of AMI in diabetics. Accurate and timely diagnosis of AMI in diabetics has been a particularly difficult problem for cardiologists and emergency physicians, and we believe our study shows that my3KG can play a major role in solving it. NewCardio is committed to developing its platform technology and deploying specific solutions with the goal of adding value across the entire spectrum of cardiology, and ultimately saving lives."
NewCardio's innovative 3-D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12L ECG. NewCardio is developing the my3KG solution for urgent diagnosis of serious cardiac conditions, including AMI. In clinical studies to date, the my3KG has shown substantially improved diagnostic accuracy relative to the standard 12L ECG, particularly in the most diagnostically challenging patients (such as those with diabetes and electrical conduction abnormalities). Accordingly, the Company believes that its innovative my3KG solution will substantially improve diagnostic timing and accuracy in life-threatening cardiac conditions, and will thereby improve clinical outcomes for a broad range of cardiac patients. The my3KG is not currently marketed for sale in the U.S. The Company intends to file an application for 510(k) approval with the FDA in 2011/2012.
About the American College of Cardiology
The American College of Cardiology is a 39,000-member nonprofit medical society comprised of physicians and allied health professionals. The College is a leader in the formulation of health policy, standards and guidelines, operates and maintains national cardiovascular patient registries, and supports cardiovascular research and professional education.
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