Clinilabs will Conduct Phase 1 Trial Using QTinnoÂ®
SANTA CLARA, Calif., Nov. 9, 2011 /PRNewswire/ — NewCardio, Inc., (OTC BB: NWCI) a cardiovascular diagnostic solutions developer, announced today that its strategic partner, Clinilabs, will utilize QTinnoÃ‚®, NewCardio’s automated cardiac safety solution, to conduct a Phase I trial of an investigational new drug under development for a central nervous system (CNS) indication. The assessment of cardiac safety will be one important aspect of the trial.
Clinilabs, located in New York City, is a full-service contract research organization that provides early-phase and specialty clinical drug development services to industry. Clinilabs has integrated QTinno into its current core lab offerings as part of its strategic initiative to deliver a full portfolio of cardiac safety and cardiac core laboratory services to industry. Providing fully automated ECG analysis as an integrated service offering, empowered by QTinno, enables Clinilabs to provide the complete range of ECG processing services now requested by pharma companies interested in assessing the cardiac safety of drugs in development.
“We are a trusted CRO with expertise in early phase development, which hinges on the assessment of drug safety and tolerability. The integration of QTinno into our ECG core laboratory enhances our ability to assess cardiac safety by using the industry’s leading automated ECG solution,” commented Dr. Gary Zammit, President and CEO of Clinilabs. “We are a one-stop-shop. Our 50-bed Phase I unit uses Holter telemetry to generate ECGs that are read in our own ECG core laboratory. Our clients are served by one vendor, one project manager, and one seamless system for completing cardiac safety studies. The integration of QTinno into our ECG core laboratory truly differentiates us from other providers in that it allows us to analyze ECGs using the most advanced technology in the industry today.”
Vincent Renz, NewCardio President and Chief Executive Officer, commented, “NewCardio is excited to support Clinilabs in the integration of QTinno in order to enhance their expertise in assessing drug safety in early phase development. Securing opportunities, such as this study, is proof that our partnership with Clinilabs is delivering value to both organizations and leading the way for best practices in cardiac safety. We look forward to continuing to work together as the industry continues in its adoption of QTinno’s superior technology which offers more accurate and precise cardiac safety data in a more timely and cost effective manner.”
NewCardio’s innovative 3D ECG platform technology dramatically improves the accuracy and significantly increases the diagnostic value of the standard 12-lead ECG. NewCardio’s lead product is QTinno, a software suite that provides an automated, comprehensive analysis of QT intervals and other ECG-based cardiac safety markers for the pharmaceutical industry and drug regulators. The Company believes that QTinno, a software-based, analytical technology is the industry’s leading solution for the delivering accurate and precise analysis of ECGs in a fully automated process to determine cardiac toxicity during drug development, with the added benefit of significant time and cost efficiencies.
Shareholder Update Conference Call
NewCardio expects to file its form 10-Q for the quarter ended September 30, 2011 on Monday, November 14, 2011. Management has scheduled a conference call for the purpose of updating shareholders and answering questions. The call is scheduled for Tuesday November 15, 2011, at 9 a.m. Eastern Time. To access the call dial 1-877-941-4775, or 1-480-629-9761 for international callers, and reference “NewCardio, Inc. Third Quarter 2011 Financial Results Conference Call.” A replay will be available for one week following the call by dialing 1-877-870-5176, or 1-858-384-5517 for international callers; reference pin number 4487430. A live and replay Webcast of the call will be available at http://viavid.net/dce.aspx?sid=00008FFD.
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 12L 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.
About Clinilabs Inc.
Clinilabs is a full-service contract research organization (CRO) that provides early-phase and specialty clinical drug development services to industry. Clinilabs is recognized globally as a leading specialty CRO, and has made important contributions to eleven successful new drug applications (NDAs) since 2001. For more information, please visit www.clinilabs.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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Jeff Stanlis, Partner
SOURCE NewCardio, Inc.