NewCardio's Chief Medical Officer, Dr. Ihor Gussak, to Present at Diabetic Drug Safety Conference Sponsored by the FDA, DIA and CSRC
Dr. Gussak to Present NewCardio Clinical Study Data Showing Cardio3KG Substantially Improves Diagnosis of Acute Myocardial Infarction in Diabetics
SANTA CLARA, Calif., Sept. 28 /PRNewswire/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiovascular diagnostic solutions developer, announced today that Dr. Ihor Gussak, NewCardio's Vice President and Chief Medical Officer, has been invited by the FDA, Drug Information Association (DIA), and the Cardiac Safety Research Consortium (CSRC) to present at the Diabetic Drug Safety Conference meeting entitled "Development of Type 2 Diabetes Mellitus Drugs: State-of-the-Art Cardiovascular Safety Assessments" which will be held on October 5-6, 2010, in Washington DC.
In his presentation entitled "Quantitative 3-dimensional Electrocardiography Substantially Improves Diagnosis of Acute Coronary Syndromes in Type II Diabetic Patients," Dr. Gussak will present results from NewCardio's recently-completed clinical study showing that NewCardio's urgent care solution, Cardio3KG™, had substantially greater accuracy than the standard 12-lead ECG (12L ECG) in diagnosing Acute Myocardial Infarction (AMI) in diabetic patients. With current technology, accurate diagnosis of AMI is notoriously difficult in diabetics, largely because the standard 12L ECG is particularly inaccurate in this patient group. Dr. Gussak and colleagues studied 155 consecutive diabetic patients with suspected AMI, and found that the Cardio3KG showed 42% greater sensitivity than 12L ECG for early detection of AMI, with equal or better specificity.
This is an important result because diabetes currently affects over 10% of adults in the US, and 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. More accurate and timely diagnosis facilitated by the Cardio3KG may lead to improved clinical outcomes in diabetics with MI. Moreover, the Cardio3KG may also improve drug safety through more accurate detection of adverse cardiovascular drug effects during clinical drug development.
Dr. Ihor Gussak, commented, "We are honored to present at this prestigious conference, which will be attended by internationally recognized scientists and professionals from regulatory bodies, the pharmaceutical industry, and academia. This forum provides us with a great opportunity to share exciting data from our latest clinical study, which shows that the Cardio3KG can substantially improve diagnosis of AMI in diabetics. We believe this will significantly improve clinical care of diabetics, and may lead to better detection of adverse drug effects during development."
NewCardio's innovative 3-D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead ECG. NewCardio is developing the Cardio3KG solution for urgent diagnosis of serious cardiac conditions, including AMI and other acute coronary syndromes. In clinical studies to date, the Cardio3KG 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 Cardio3KG solution will substantially improve diagnostic speed and accuracy in life-threatening cardiac conditions, and will thereby improve clinical outcomes for a broad range of cardiac patients. The Cardio3KG is not currently marketed for sale in the U.S. The Company intends to file an application for 510(k) approval with the FDA during 2011.
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.
Forward-Looking Statements
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, 2009 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 |
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SOURCE NewCardio, Inc.
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