Source : NewCardio, Inc.
SANTA CLARA, Calif.,April 7, 2011 /PRNewswire/ -- PR Newswire - NewCardio, Inc., a cardiac diagnostic technology provider, announced today that the Company has been invited by the American Diabetes Association (ADA) 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 71st Annual ADA Scientific Sessions to be held in San Diego, CA, June 24-28, 2011. In addition, the ADA has selected this presentation to be showcased in the Guided Audio Poster Tour, which features expert moderators that share their perspectives with attendees, highlighting novel and important developments in the field.
Dr. Ihor Gussak, MD, PhD, NewCardio's Chief Medical Officer, commented, "We are delighted to present our study results at this important gathering of diabetes experts, and particularly pleased that the ADA program committee chose to feature our presentation in a moderated poster session. Accurate and timely AMI diagnosis is a matter of great concern for diabetologists, and we believe our results show that my3KG can play a major role in solving it. The moderated poster session provides the opportunity to present our results directly to leading diabetes experts, and have one-on-one interactions that will allow us to discuss and explain the importance of our results in detail."
Study Background and Results
Diabetics with AMI represent a very large and growing patient group, and currently affect over 10% of adults in the U.S. Moreover, the incidence of AMI is two to four times greater in diabetics than in the general population, according to ADA and American Heart Association statistics. 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 showed that my3KG had 42% greater sensitivity than expert cardiologist interpretation of 12L ECG for early detection of AMI, with equal or better specificity. Based on these important results, NewCardio believes use of my3KG in this patient group may facilitate more accurate and timely diagnosis of AMI in diabetic patients, thereby improving clinical outcomes.
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 Diabetes Association
The ADA is a volunteer-driven organization based in Alexandria, VA, with affiliate offices across the U.S. The mission of the ADA is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. To fulfill this mission, the Association funds research, publishes scientific findings, provides information and other services to people with diabetes, their families, health professionals and the public. The Association is also actively involved in advocating for scientific research and for the rights of people with diabetes. The Association acts on its mission through a number of critical programs and activities that are directed to a broad range of constituents, including consumers, research scientists, health care professionals, corporations and communities.
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company developing and marketing proprietary software platform technologies to provide higher accuracy to, and increase the value of, the standard 12L ECG. NewCardio's 3-D ECG software platform reduces the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. NewCardio's software products and services significantly improve the diagnosis and monitoring of cardiovascular disease, as well as cardiac safety assessment of drugs under development. For more information, visit www.newcardio.com.
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2010 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
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Jeff Stanlis, Partner
Web site: http://www.newcardio.com/