SANTA CLARA, Calif., March 31, 2011 /PRNewswire/ -- NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiovascular diagnostic solutions developer, announced today that the Company has been invited to present the results of a recent QTinno ® performance study at an upcoming conference entitled "Cardiovascular Safety in Drug Development: State-of-the-Art Assessments," sponsored by the U.S. Food and Drug Administration (FDA), the Cardiac Safety Research Consortium (CSRC) and the Heart Rhythm Society. The conference will be held in Washington, DC, on April 14-15, 2011.
The NewCardio study shows that QTinno's intelligent ECG selection and extraction provides accurate and optimized, consistent and automated selection of electrocardiograms (ECGs) from continuous 24 hour ECG recordings (Holter monitors), leading to improved study power and a substantial reduction in the number of study subjects needed to achieve the desired study power in early Phase QT studies, to include Thorough QT studies (TQTS). The results will be presented by Dr. Samuel George, NewCardio's Senior Medical Advisor, on behalf of NewCardio co-investigators Drs. Ihor Gussak and Branislav Vajdic. The study was done in collaboration with physician-scientists from a major pharmaceutical partner.
The study that will be presented at the FDA/CSRC/HRS conference addresses the need for reliable and reproducible ECG selection from Holter monitors. At present, the user visually selects three 10-second ECGs from the recording within five minutes of each designated study time point, a labor-intensive approach that is prone to error, increased variability and low reproducibility. NewCardio developed a novel "intelligent" ECG selection algorithm that evaluates the entire 10-minute window around the designated time point and selects the lowest noise and most stable ECGs in the window. The study shows NewCardio's intelligent ECG selection method yields more accurate and precise data than visual ECG selection, resulting in a substantial improvement in study power, and a large reduction in the number of study subjects needed to achieve the desired power. This proprietary advancement will allow sponsors to see significant cost reductions from studies, not just from the fully automated ECG analysis QTinno provides, but also because they will have the ability to conduct the study with fewer study subjects.
Dr. Ihor Gussak, NewCardio's Chief Medical Officer, commented, "We were delighted with the significant improvement in measurement variability and study power that we observed in this investigation. We look forward to sharing this exciting data at this important conference, which is attended by cardiovascular safety experts from regulatory bodies, pharmaceutical companies, clinical research organizations and academia. The improvement conferred by our new automated ECG selection algorithm offers sponsors the opportunity to reduce the number of subjects in a study without sacrificing study power, which may result in substantial cost savings. The new algorithm is a powerful extension of our platform technology, and further demonstrates NewCardio's ability to add value to every ECG."
Vincent Renz, CEO of NewCardio, commented, "These study results represent yet another important and substantial technological innovation for QTinno that further differentiates QTinno from competition and solidifies QTinno's position as the industry's leading automated solution for drug safety studies. This is further evidence that NewCardio will continue to enhance QTinno in order to eliminate the manual, labor intensive procedures employed in the current cardiac safety methodologies, which typically affect the drug sponsors through longer timelines, higher costs and from our findings, lower quality. We believe that our latest innovation, intelligent ECG extraction, will provide additional gains that will allow the pharmaceutical industry to complete higher quality cardiac safety analysis faster, more reliably, and at significantly lower cost."
Cardiovascular Safety in Drug Development: State-of-the-Art Assessments
Co-sponsored by FDA, Cardiac Safety Research Consortium, and Heart Rhythm Society
Date(s) And Time(s):
Apr 13 2011 8:00AM - Apr 15 2011 1:00PM
L'Enfant Plaza Hotel
480 L'Enfant Plaza Southwest
Washington, DC 20024-0478
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 the Cardiac Safety Research Consortium
The Cardiac Safety Research Consortium (CSRC) was launched in 2006 under the FDA Critical Path Initiative with the mission of advancing scientific knowledge on cardiac safety for new and existing medical products. CSRC supports research by engaging stakeholders from industry, academia, and government to share data and expertise. Key objectives include facilitating focused pragmatic research that will inform regulatory processes with regard to cardiac safety, and to develop knowledge and strategies intended to improve the evaluative sciences in relation to cardiac safety and product development. For more information, visit www.cardiac-safety.org.
About the Heart Rhythm Society
The Heart Rhythm Society is the international leader in science, education and advocacy for cardiac arrhythmia professionals and patients, and the primary information resource on heart rhythm disorders. Its mission is to improve the care of patients by promoting research, education and optimal health care policies and standards. Founded in 1979, the Heart Rhythm Society has a membership of more than 5,300 physicians, scientists and associated professionals representing more than 70 countries. As the leading professional group representing the allied specialties of cardiac pacing and cardiac electrophysiology, the Society plays an important role not only in education, but also as an intermediary between government regulatory agencies and its members.
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.