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
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