NewCario Inc., a cardiovascular diagnostic solutions developer, today announced that a Top 5 global pharmaceutical company has selected NewCardio’s QTinno® automated cardiac safety solution for two phase I drug safety studies slated to begin in March.
The QTinno 3-D ECG software technology is designed to assess drug cardiac toxicity in drug development. The company anticipates that 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.
In accordance with the terms of an existing Master Services Agreement, NewCardio’s QTinno-powered, fully automated ECG analysis will be delivered by the ECG core lab of a Top 3 Clinical Research Organization (CRO).
NewCardio said the unnamed pharmaceutical company selected QTinno 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 also a critical deciding factor, 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.
“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,” Vincent Renz, NewCardio president and CEO stated in the press release.
Renz said NewCardio’s business model allows the company to work with various industry players rather than competing with them.
“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,” 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,” Renz stated.
The studies are expected to be completed by June 2011; NewCardio expects to recognize revenue from the studies in the first half of 2011.
For more information visit www.newcardio.com