NewCardio Presents Results for Cardiac Safety Research Consortium Blinded Drug Safety Study
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 CE