SANTA CLARA, Calif., July 30 /PRNewswire-FirstCall/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic and services company, today announced that a top-five pharmaceutical company has named NewCardio's QTinno(TM) software suite, NewCardio's first commercial product, as the technology that will be used in all of its fully automated Thorough QT (TQT) studies.
The pharmaceutical company evaluated several automated cardiac safety solutions before choosing QTinno(TM) as its automated solution moving forward. As part of this evaluation, a blinded TQT dataset was provided for processing by the automated solutions. The automated results were then un-blinded by the pharmaceutical company and compared to the original core lab results. The pharmaceutical company determined that NewCardio's solution demonstrated the highest consistency and lowest variability in relation to the original core lab results. After reviewing NewCardio's underlying platform technology, the pharmaceutical company determined that QTinno(TM) was the solution it will utilize to begin replacing the semi-automated methodology currently utilized by its preferred ECG core labs. At recent industry conferences, a number of pharmaceutical companies have expressed a strong desire to transition to fully automated methods in an effort to reduce human error, minimize intrinsic variability and increase efficiency.
Going forward, all TQT study requests for proposals (RFPs) issued by the pharmaceutical company that will require a fully automated component will require the use of NewCardio's QTinno(TM) by its preferred ECG core labs. It is anticipated that this pharmaceutical company will conduct its first clinical trial using fully automated readings by the end of the year and will increasingly utilize fully automated results in its TQT studies.
"NewCardio is excited to work with a major pharmaceutical company and we believe this is the clearest signal yet of the impending transition to fully automated cardiac testing in drug development as sponsors look for ways to improve quality while simultaneously reducing expenses," said Vincent Renz, NewCardio's President and Chief Operating Officer. "This global pharmaceutical leader is an early adopter, and this announcement demonstrates their commitment to quality, safety and the use of new technologies to drive innovation."
NewCardio's innovative 3D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead electrocardiogram (ECG). NewCardio's lead product is QTinno(TM), a software suite that provides an automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety for the pharmaceutical industry and drug regulators. The Company believes that its QTinno(TM), software-based, analytical technology is the industry's first solution for the reliable automated analysis of ECGs used to determine cardiac toxicity during drug development.
About NewCardio, Inc.
NewCardio is a cardiac diagnostic and services company focused on the development of a proprietary platform technology to provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's development-stage software and hardware products and services are intended to improve the diagnosis and monitoring of cardiovascular disease (CVD), as well as cardiac safety assessment of drugs under development. NewCardio's three-dimensional ECG platform is designed to reduce the time and expense involved in assessing cardiac status while increasing the ability to diagnose clinically significant conditions which were previously difficult to detect. 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, 2008 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. Information concerning factors that could cause our actual results to differ materially from these forward-looking statements can be found in our periodic reports filed with the Securities and Exchange Commission. We assume no obligation to, and do not currently intend to, update these forward-looking statements.
Investor Contact: Hayden IR Jeff Stanlis, Partner and VP of Communications (602) 476-1821 firstname.lastname@example.org
|SOURCE NewCardio, Inc.|
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