Top 3 Clinical Research Organization Selects QTinno for a Phase I Drug Safety Trial
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 QTinnoÃ‚®, 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.
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, 2010 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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SOURCE NewCardio, Inc.