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NewCardio Announces Publication by Heart Rhythm of Cardio3KG Clinical Study to Improve Acute Cardiac Diagnosis

Study Published by Prestigious Peer-Reviewed Journal of the Heart Rhythm Society


News provided by

NewCardio

Sep 08, 2010, 08:00 ET

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SANTA CLARA, Calif., Sept. 8 /PRNewswire-FirstCall/ -- NewCardio (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, announced today that a clinical study of the Cardio3KG™ in acute cardiac diagnosis has been published in the August 2010 issue of the peer-reviewed journal, Heart Rhythm, the official journal of the Heart Rhythm Society. The study, entitled "Vectorcardiographic and Electrocardiographic Criteria to Distinguish New and Old Left Bundle Branch Block," was led by Alexei Shvilkin, MD, PhD, Peter Zimetbaum, MD, Kalon Ho, MD, and Mark Josephson, MD, from the Cardiology Division at Beth Israel Deaconess Medical Center and Harvard Clinical Research Institute, Boston, in collaboration with Ihor Gussak MD, PhD, Bosko Bojovic PhD, and Branislav Vajdic, PhD, from NewCardio.

Patients in Emergency Departments (ED) with suspected myocardial infarction (MI), commonly referred to as a heart attack, frequently have a diffuse 12-lead ECG abnormality known as Left Bundle Branch Block (LBBB). Unfortunately, this abnormality makes it difficult or impossible to "read" the ECG for signs of an acute heart attack. Because of this uncertainty, the great majority of LBBB patients are taken directly for invasive interventional procedures. In most such patients, however, the LBBB abnormality is an old and stable finding unrelated to the patient's current symptoms, and the procedures expose the patient to unnecessary risk and discomfort, as well as adding to healthcare costs. Thus, a fast, reliable and inexpensive way to distinguish patients with "old" LBBB from patients with "new" LBBB is needed.

Dr. Shvilkin and colleagues obtained ECG data from 39 patients with new LBBB and 1760 patients with old LBBB, and used NewCardio's Cardio3KG suite of 3D-based ECG analysis algorithms to identify a novel Cardio3KG marker called the QRS-T Loop ratio. This allowed highly accurate discrimination between new and old LBBB (100% sensitive and 96% specific for correctly assigning LBBB tracings to the "new" or "old" category). This important advance is expected to provide a cost-effective solution to a long-standing and notoriously difficult diagnostic dilemma in acute MI diagnosis. Moreover, because the Cardio3KG uses standard 12-lead ECG input, its analytical results are available in minutes and require no change in standard ED practices or special training of the ED staff.

Dr. Shvilkin, the study's Principal Investigator, commented: "We believe these study results have substantial clinical significance. The ability of Cardio3KG to identify old LBBB will help reduce unnecessary invasive procedures and lower the overall cost of medical care. On the other hand, the accurate identification of new LBBB by Cardio3KG will reinforce the need for aggressive management and urgent coronary intervention, and may thereby improve long-term clinical outcomes for acute MI patients."

Dr. Gussak, NewCardio's Chief Medical Officer and a study co-investigator, commented: "The paper makes a major and exciting contribution to acute MI diagnosis. Our clinical studies to date have shown a substantial improvement in sensitivity for diagnosing a heart attack. The latest results show that Cardio3KG accurately identifies new LBBB, adding to the diagnostic power of this solution. We are very fortunate to work with Dr. Shvilkin and his Harvard colleagues on this and other Cardio3KG studies. Their work represents truly innovative and important contributions, and we look forward to many more."

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 12-lead 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.

To join our email distribution please click this link: http://www.b2i.us/irpass.asp?BzID=1645&to=ea&s=0

Investor Contact:

Hayden IR

Jeff Stanlis, Partner

(602) 476-1821

[email protected]

SOURCE NewCardio

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