SANTA CLARA, Calif., Dec. 10, 2010 /PRNewswire/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiovascular diagnostic solutions developer, today presented the results from a blinded drug safety study conducted by the Cardiac Safety Research Consortium (CSRC) to evaluate the performance of QTinno™ on its "testing" ECG dataset. The CSRC blinded "testing" dataset, comprised of 11,672 electrocardiograms (ECGs) from the moxifloxacin and placebo arms of a recent parallel-group Thorough QT Study. The CSRC blinded study results show, by a variety of analytical approaches, that QTinno accurately detects moxifloxacin-induced QT interval prolongation with statistically significant and substantial reductions in measurement variability compared to sponsor-submitted data. In QT studies, lower measurement variability increases the quality of study results and may enable future studies to be done in a more cost effective manner, thereby potentially reducing expenses for cardiac safety studies, which is a significant value proposition for QTinno users.
The study results were presented yesterday (December 9, 2010) to key representatives from the Food and Drug Administration (FDA), pharmaceutical companies, and academia by Samuel George, MD, FACC, JD, NewCardio's Senior Medical Advisor, at the CSRC's Annual Meeting. The CSRC makes its blinded "testing" dataset available to any cardiac safety technology developer who accepts the conditions that the blinded analysis is conducted independently by the CSRC without any company involvement, and that any results obtained will be made public by the CSRC (www.cardiac-safety.org/ecg-database/rules_of_engagement.pdf). NewCardio is the first such entity to accept the CSRC conditions and complete the study.
Vincent Renz Jr., NewCardio's President and CEO commented, "We are very excited that QTinno was the initial automated cardiac safety solution whose performance was evaluated against the CSRC blinded 'testing' data set, for two reasons. First, based on the QTinno validation studies done to date with partners from Pharma, clinical trial service providers and academia, we expected, and realized, statistically significant results from this blinded drug safety study. QTinno has consistently returned highly accurate results with lower variability than other comparator methods, be it manual, semi-automated or automated, just as it did in the CSRC study. And second, it provided another opportunity for us to enhance our collaborative efforts with the CSRC in utilizing the underlying science and technology of QTinno to advance the current state of cardiac safety testing."
In the study, the CSRC made detailed comparisons of QTinno measurements to those originally submitted to the FDA by a drug sponsor in an FDA mandated cardiac safety drug study as required under the ICH E14 Guidance. The primary endpoint of this analysis was the accurate detection of the control drug's (moxifloxacin) effect on QT intervals, and the precision of the submitted measurements. Detailed results of this study will be submitted for publication in a peer-reviewed journal in the near future, and will be posted on the NewCardio website after peer-reviewed publication.
Dr. Ihor Gussak, NewCardio's Chief Medical Officer, stated, "We commend the CSRC for the excellent design and execution of this very important study, and we are proud that QTinno once again proved its accuracy in this rigorous examination. The study results provide compelling, and completely independent evidence that QTinno returns industry leading, fully automated accuracy in clinical drug studies, and does so with significantly reduced measurement variability. We believe that QTinno has the potential to increase the power of future studies and reduce study expenses for pharmaceutical drug sponsors."
Mr. Renz, continued, "Validation of new technologies is critical, and FDA representatives have consistently stated that they are willing to accept clinical results using automated ECG measurements from any validated methodology and the results from all of our validation efforts, which now include this CSRC study, more than meet FDA standards for validation, and as such QTinno is acceptable to the FDA. We believe that there will come a point where, based on the quality of performance, the industry will move from validation to the acceptance of methodologies which not only deliver high quality results, but do so in a more timely and cost effective manner. The blinded CSRC study results reinforce the strength of QTinno's performance with both current and potential customers and, more importantly we believe this clearly establishes the critical role of QTinno as the drug development industry accelerates their adoption of the higher quality, cost effective cardiac safety analysis."
About QTinno TechnologyNewCardio's patented QTinno 3-D ECG software technology is a novel, fully automated program for evaluating QT and other timing intervals relevant for assessing drug cardiac toxicity in drug development. It provides fast, accurate and precise QT data from a broad range of challenging ECGs and enables reliable, automated identification of key cardiac events. Pharmaceutical sponsors and clinical research organizations, which are mandated by the FDA to test new drugs for potential cardiac toxicity, are expected to benefit from QTinno's faster, more accurate and less expensive assessment of cardiac status.
About the Cardiac Safety Research ConsortiumThe CSRC was launched in 2006 under the FDA Critical Path Initiative with the mission of advancing scientific knowledge on cardiac safety for new and existing medical products. CSRC supports research by engaging stakeholders from industry, academia, and government to share data and expertise. Key objectives include facilitating focused pragmatic research that will inform regulatory processes with regard to cardiac safety, and to develop knowledge and strategies intended to improve the evaluative sciences in relation to cardiac safety and product development. For more information, visit www.cardiac-safety.org.
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 StatementsThis 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.
|SOURCE NewCardio, Inc.|
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