SANTA CLARA, Calif., Nov. 9, 2010 /PRNewswire-FirstCall/ -- NewCardio, Inc. (OTC Bulletin Board: NWCI), a cardiovascular diagnostic solutions developer, announced today that Dr. Samuel George, NewCardio's Senior Medical Advisor, will present the results of QTinno performance on a blinded "testing" dataset, conducted independently by the Cardiac Safety Research Consortium (CSRC), at the CSRC's Annual Meeting, to be held on December 9, 2010, at the headquarters of the Food and Drug Administration (FDA) in Silver Spring, MD.
At the meeting, Dr. George will present results of a blinded validation study in which CSRC-affiliated investigators independently evaluated the accuracy and precision of fully automated QTinno measurements in 11,672 electrocardiograms (ECGs) from the moxifloxacin and placebo arms of a recent Thorough QT Study (TQTS). In the study, the CSRC investigators made detailed comparisons of QTinno measurements to those originally submitted by the drug sponsor, with the primary comparators of accurate detection of the moxifloxacin effect on QT intervals.
The CSRC makes this blinded TQTS "testing" dataset available to automated cardiac safety technology solution providers, with the conditions that the blinded analysis is conducted independently by the CSRC without any company involvement, and that any (either favorable or unfavorable) results obtained will be made public. NewCardio is the first company which has agreed to these conditions and completed the evaluation.
Dr. Ihor Gussak, NewCardio's Chief Medical Officer, commented, "We are very proud to be the first automated cardiac safety solution to accept the rules of engagement defined by the CSRC for evaluating the performance of our automated solution, QTinno, utilizing the blinded CSRC 'testing' dataset. Our willingness to enter into this very important and strictly regulated validation study reflects our high level of confidence in the accuracy and precision of the fully automated ECG measurements provided by QTinno. Prior to this blinded CSRC validation study, we have validated QTinno extensively, in collaboration with partners from Pharma, Clinical Research Organizations, and Academia. In every one of these 9 validation studies performed to date, which included over 100,000 ECGs, QTinno has provided highly accurate, fully automated measurements with an average 19% reduction in QT/QTc measurement variability. Based on this consistent performance in prior studies, we are confident that QTinno will perform well in any head to head comparison with the current ECG analysis methodologies."
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.
About the Cardiac Safety Research ConsortiumThe Cardiac Safety Research Consortium (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.
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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