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.
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.
This press release contains forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions. These statements are based on current expectations, estimates and projections about our business based on currently available information and assumptions made by management. Although we believe that the assumptions on which the forward-looking statements contained herein are based are reasonable, any of those assumptions could prove to be inaccurate given the inherent uncertainties as to the occurrence or nonoccurrence of future events. These statements are not guarantees of future performance and involve risks and uncertainties that are difficult to predict. Therefore, actual outcomes and results may, and are likely to, differ materially from what is expressed or forecasted in the forward-looking statements due to numerous factors, including the potential risks and uncertainties set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2009 and relate to our business plan, our business strategy, development of our proprietary technology platform and our products, timing of such development, timing and results of clinical trials, level and timing of FDA regulatory clearance or review, market acceptance of our products, protection of our intellectual property, implementation of our strategic, operating and people initiatives, benefits to be derived from personnel and directors, ability to commercialize our products, our assumptions regarding cash flow from operations and cash on-hand, the amount and timing of operating costs and capital expenditures relating to the expansion of our business, operations and infrastructure, implementation of marketing programs, our key agreements and strategic alliances, our ability to obtain additional capital as, and when, needed, and on acceptable terms and general economic conditions specific to our industry, any of which could impact sales, costs and expenses and/or planned strategies and timing. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
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Jeff Stanlis, Partner
SOURCE NewCardio, Inc.