Top 5 Global Pharmaceutical Company Selects NewCardio's QTinno for 2 Upcoming Phase I Drug Safety Trials
Fully Automated ECG Analysis, Empowered by QTinno, to be Delivered Through Integrated Clinical Trial Services Provided by Top 3 CRO
SANTA CLARA, Calif., March 17, 2011 /PRNewswire/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiovascular diagnostic solutions developer, announced today that a top 5 global pharmaceutical company has selected QTinno®, their automated cardiac safety solution, for two Phase I drug safety studies. Fully automated ECG analysis, empowered by QTinno, will be delivered by the ECG core lab of a top 3 Clinical Research Organization (CRO) under the terms of an existing Master Services Agreement with NewCardio.
The studies start in March and are expected to be complete by June of 2011. QTinno was selected based on its proven ability to enable the CRO to deliver high-quality results in a much more timely and cost effective manner than the current core ECG lab methodologies. Turnaround time was a critical factor in choosing QTinno in these studies, as the sponsor needs to present the results to the FDA for review after Part 1 of the initial study in order to develop the requirements for Part 2 of the study, to be started shortly after the completion of Part 1. NewCardio expects to recognize revenue from the studies in the first half of 2011.
Vincent Renz, NewCardio President and Chief Executive Officer, commented, "We are excited to participate in these important studies, and gratified that a major global pharmaceutical company specifically identified QTinno for automated analysis of all the ECGs from the studies. QTinno's selection for these studies provides clear evidence of the pharmaceutical company's confidence, not only in the accuracy and precision of QTinno's fully automated ECG analysis, but also in the FDA's willingness to accept drug safety data from properly validated technology such as QTinno. We expect that QTinno will play an increasingly important role as the drug development industry accelerates their adoption of the higher quality, cost effective cardiac safety analysis."
"This selection represents further evidence of the increasing market adoption of QTinno, not only as a validated methodology, but also as a clear leader in delivering advanced technology solutions for the drug development industry," Mr. Renz continued. "Our business model as a technology developer, not an ECG core lab, enables us to work effectively with all of our customers and partners as we are not competing with them but rather equipping them with solutions and enabling them to deliver enhanced clinical trial products and services. We are pleased that industry leaders are embracing QTinno, and we look forward to an accelerating adoption cycle with increasing market penetration."
About QTinno Technology
NewCardio'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.
