NewCardio Invited to Present Latest QTinno Performance Improvements at FDA-Sponsored Conference on Cardiovascular Safety in Drug Development
SANTA CLARA, Calif., March 31, 2011 /PRNewswire/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiovascular diagnostic solutions developer, announced today that the Company has been invited to present the results of a recent QTinno ® performance study at an upcoming conference entitled "Cardiovascular Safety in Drug Development: State-of-the-Art Assessments," sponsored by the U.S. Food and Drug Administration (FDA), the Cardiac Safety Research Consortium (CSRC) and the Heart Rhythm Society. The conference will be held in Washington, DC, on April 14-15, 2011.
The NewCardio study shows that QTinno's intelligent ECG selection and extraction provides accurate and optimized, consistent and automated selection of electrocardiograms (ECGs) from continuous 24 hour ECG recordings (Holter monitors), leading to improved study power and a substantial reduction in the number of study subjects needed to achieve the desired study power in early Phase QT studies, to include Thorough QT studies (TQTS). The results will be presented by Dr. Samuel George, NewCardio's Senior Medical Advisor, on behalf of NewCardio co-investigators Drs. Ihor Gussak and Branislav Vajdic. The study was done in collaboration with physician-scientists from a major pharmaceutical partner.
The study that will be presented at the FDA/CSRC/HRS conference addresses the need for reliable and reproducible ECG selection from Holter monitors. At present, the user visually selects three 10-second ECGs from the recording within five minutes of each designated study time point, a labor-intensive approach that is prone to error, increased variability and low reproducibility. NewCardio developed a novel "intelligent" ECG selection algorithm that evaluates the entire 10-minute window around the designated time point and selects the lowest noise and most stable ECGs in the window. The study shows NewCardio's