Pharma Lynx Signs MSA with NewCardio for Phase 1 QT Studies using QTinno

SANTA CLARA, Calif., Sept. 16 /PRNewswire/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiovascular diagnostic solutions developer, announced today that Pharma Lynx, a global contract research organization and a subsidiary of Diverse Lynx, has signed an MSA to license NewCardio's QTinno™ solution for use in Phase 1 studies. Pharma Lynx has particular expertise in oncology studies, including QTc studies involving both healthy subjects and cancer patients, and QTinno will add to Pharma Lynx's already robust capabilities, enabling it to deliver fully automated QTc studies to its sponsors.

In addition,  Pharma Lynx has signed a services work order, which includes the delivery of standard operating procedures (SOP) and validation kits, as well as professional services, in order to accelerate the integration of QTinno into its core clinical trial service offerings and as such, its readiness for delivering  ECG core lab services to its sponsor customers.

Vincent Renz, NewCardio's President and Chief Executive Officer, commented, "This agreement is further evidence of growing market awareness, and more importantly, market adoption of QTinno, our automated cardiac safety solution, as an alternative to the current methodologies employed in QTc studies, given its ability to deliver quality ECG analysis in a more timely and cost effective manner.  Forward thinking clinical trial service providers are responding to the demands of pharmaceutical sponsors to increase the breadth of their available products and services, minimizing the number of vendors to manage, and deliver those services in a more cost effective manner.  QTinno enables them to meet both of those demands. Pharma Lynx, as one of those innovative providers, is looking to establish itself as a market leader in delivering a broad scope of trial services in a cost effective manner through the implementation of advanced technology, which QTinno, as well as the NewCardio business model, is well positioned to support.  We look forward to working with the Pharma Lynx team as they integrate QTinno into their core clinical trial workflow, thereby increasing their revenue potential through the delivery of quality cardiac safety services."

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 software solution for performing high quality, cost effective automated cardiac safety analysis in drug development.

Shubhendra Varma, President/CEO commented, "We are delighted to enter into this professional relationship with NewCardio, which we believe is a critically important step towards improving drug cardiac safety assessment.  This is particularly true in oncology, where thorough QT and other early-phase clinical studies face unique and very substantial technical and clinical challenges. We believe this partnership with NewCardio is a prestigious and important step that reinforces our firms commitment to meeting our sponsors' drug development needs, in Oncology and in other therapeutic arenas as well."

Dr. Ashok Srivastava, Chief Medical Officer, Global Executive Vice President Clinical and Medical Affairs at Pharma Lynx added, "We have a strong and robust service CRO infrastructure in over 25 countries in Americas, Europe, Japan and other Southeast Asian countries including India.  This agreement with NewCardio enables us to expand our breadth of services by delivering high quality cardiac safety services to our drug development sponsors throughout the world.  Adding both superior QTinno technology along with NewCardio's expertise in cardiac safety allows us to offer leading pharmaceutical and biotechnology companies a precise, cost-effective, and efficient solution for ECG data analysis.  We are eager to provide our comprehensive and accurate cardiac safety solution to our global sponsors, setting the stage for additional growth through our QT analysis."

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.

Forward-Looking Statements

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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SOURCE NewCardio, Inc.

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