NewCardio Release: Top 3 Clinical Research Organization Selects QTinno for a Phase I Drug Safety Trial
Published: Nov 29, 2011
PRINCETON, N.J., Nov. 29, 2011 /PRNewswire/ -- NewCardio, Inc., (OTC BB: NWCI) a cardiovascular diagnostic solutions developer, announced today that a top 3 Clinical Research Organization (CRO) will utilize QTinno®, automated cardiac safety solution, to support a Phase I drug safety study for a biopharmaceutical sponsor. Fully automated ECG analysis, empowered by QTinno, will be delivered at the CRO's clinical pharmacology research unit under the terms of an existing Master Services Agreement with NewCardio.
NewCardio has been asked to install QTinno at the second of this CRO's Phase 1 units, enabling them to complete an ongoing study for their biopharmaceutical sponsor. The study is expected to provide more refined data compared to previous analysis conducted for the cardiac safety profile of the compound. NewCardio expects to recognize the revenue from this study during the fourth quarter of 2011.
"The recommendation by the CRO to the sponsor to utilize QTinno for this Phase 1 study is recognition that QTinno provides accuracy and timeliness, at lower cost," said Vincent Renz, NewCardio's Chief Executive Officer. "We are excited to have achieved this milestone, and look forward to this leading to additional business with the clinical resources provider and their sponsors in the future."
NewCardio's innovative 3-D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead ECG. NewCardio's lead product, QTinno, is a software suite that provides automated, comprehensive cardiac safety analysis as defined in the ICH E14 Guidance for Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs. The Company believes that QTinno, based on NewCardio's technology and approach, is the industry's most advanced, validated solution for performing high quality, cost effective automated cardiac safety analysis in drug development.
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.
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.
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SOURCE NewCardio, Inc.