NewCardio Announces Positive Results From Third Clinical Validation Study
Test validates QTinno(TM) - proves the ability to automatically measure QT intervals in even challenging samples
SANTA CLARA, Calif., August 13, 2008 /PRNewswire-FirstCall/ -- NewCardio, Inc., a cardiac diagnostic and services company, today revealed the results of its third external validation study of QTinno(TM) (the "NCE3 Study"). The study was led by an independent industry leading cardiac safety expert with extensive experience in pharmaceutical clinical trials. The study evaluated the accuracy, precision and speed of NewCardio's lead product, QTinno(TM), in producing fully automated measurements of drug-induced QT prolongation, a key cardiac safety indicator. Such data is now required by drug regulatory bodies worldwide for all new drugs in development, and at present must be obtained by expensive and time-consuming manual or semi-automated methods.
The NCE3 study was a randomized, blinded study of more than 2,500 digital ECGs acquired from healthy research subjects treated with either placebo or a cardiac drug with significant QT-prolonging properties and a known propensity to cause serious cardiac arrhythmias. QT intervals were determined on all study ECGs by QTinno(TM) and by the current "gold standard" approach: careful manual reading by a single cardiologist with extensive expertise and experience in ECG evaluation. The primary endpoint, time-matched, placebo-controlled QT prolongation induced by drug, was chosen because drug-induced QT prolongation is the primary parameter that regulatory bodies evaluate to assess the cardiac arrhythmia risk of a new drug candidate.
Results from the NCE3 study showed that QTinno(TM) was accurate in measuring drug-induced QT prolongation. The automated determination derived at by QTinno(TM) and the "gold standard" manual measurement were virtually identical (well under 1 millisecond difference), and individual measurements showed a high degree of precision (standard deviation of less than 10 milliseconds between the two approaches).
The NCE3 results show excellent agreement with the Company's prior external clinical validation studies (NCE1 and NCE2). Moreover, they extend the clinical validation of QTinno(TM) in at least two important ways. First, ECGs in the NCE3 study had much higher levels of electrical noise and artifacts than ECGs from NCE1 and NCE2 studies. Accordingly, the NCE3 study validates QTinno(TM) performance in a significantly more challenging environment than is typical for early-stage QT assessment. Second, the NCE3 study validates QTinno(TM) performance in an instance where the study drug not only causes substantial QT prolongation and T wave abnormalities, but is also known to induce significant and potentially lethal cardiac arrhythmias.
Branislav Vajdic, Ph.D., President and Chief Executive Officer, commented, "The exceptional accuracy of the QTinno(TM) tool was clearly validated by this third, and most challenging clinical study to date. The evidence unequivocally demonstrates that the QTinno(TM) is not only faster at measuring the QT interval compared to current manual and semi-automated approaches, but that it also provides proven levels of accuracy even in challenging conditions and with complex compounds. We believe it provides an important additional independent validation that will help potential customers recognize the value of NewCardio's cardiac assessment tool. In aggregate, the three independent studies collectively provide NewCardio with a robust clinical validation portfolio that demonstrates QTinno(TM) accuracy and precision in measuring key drug safety metrics across a broad range of compounds, and in comparison to a variety of manual and semi-automated 'gold standard' measurements from three different sources."
Dr. Vajdic continued, "The Company is now actively pursuing commercial validation of QTinno(TM) and is in discussion with potential CRO partners. We also anticipate developing an interface to discuss these important and compelling clinical validation data with drug regulators. We will soon augment our senior management team in an effort to add sales and marketing leadership to accelerate the commercialization initiative."
QTinno(TM) is a software suite that provides automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. Its key features include full automation with minimal to no human intervention required, greatly improving the productivity, accuracy and precision of clinical trials. NewCardio believes QTinno(TM) is equal to the best manual assessments and is able to provide high-quality quantitative data from a broad range of difficult-to-read ECGs.
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company focused on the development of a proprietary platform technology to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's development-stage software and hardware products and services are intended to improve the diagnosis and monitoring of cardiovascular disease (CVD), as well as cardiac safety assessment of drugs under development. NewCardio's three-dimensional ECG platform is designed to reduce the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. For more information, visit http://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/A (No. 1) for the year ended December 31, 2007 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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Posted: August 2008