SANTA CLARA, Calif., Feb. 24, 2011 /PRNewswire/ -- PR Newswire NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiovascular diagnostic solutions developer, announced today that the Company has been invited by the Heart Rhythm Society (HRS) to present results of a recent clinical study showing that recurrent atrial fibrillation (AF) was accurately and timely detected in patients who used CardioBip for daily monitoring following catheter ablation procedures. The presentation, entitled “Long-term Intermittent Wireless Remote Monitoring of Reconstructed 12-Lead ECG in Post-Ablation AF Patients Using the CardioBip System”, will be made at the 32nd Annual Scientific Sessions of the HRS, to be held in San Francisco, CA, May 4-7, 2011.
AF affects an estimated 1% of the worldwide population, with nearly three million AF patients in the US and six million AF patients in Europe. It is a serious medical condition that doubles mortality risk and increases risk of stroke by five-fold. Accordingly, such patients often need ambulatory monitoring to detect AF recurrences. Currently available AF monitoring devices have significant limitations, such as relatively few monitoring leads and the need to wear a device with attached wires and skin electrodes. CardioBip addresses these limitations as it does not employ any skin electrodes or wires. The handheld device conveniently records and wirelessly transmits information sufficient to reconstruct a full 12-lead ECG.
Vincent Renz, CEO of NewCardio, commented, “We are delighted to be presenting our latest CardioBip clinical study at the HRS Annual Scientific Meeting, a prestigious forum that is well-attended by cardiologists and electrophysiologists with a particular interest in novel solutions for long-term ambulatory cardiac monitoring. The exciting data from this study provide additional and very solid supporting evidence for our belief that CardioBip is exceptionally well-suited for long-term cardiac monitoring. There are more than 30 million patients in the US and throughout the world - who have atrial fibrillation or other cardiac arrhythmias, and could benefit from using the CardioBip solution. We look forward to sharing the data with our HRS colleagues, and to building market awareness of CardioBip’s efficacy, ease of use, and suitability for this important clinical need.”
In the study, 21 patients who underwent catheter ablation for AF were given CardioBip devices and asked to provide daily transmissions for 60 days and additional transmissions whenever symptoms (such as palpitations or dizziness) developed. Patients also had 24-hour, continuous 12-lead ECG recordings (Holter monitors [HM]), a commonly-used method for AF surveillance, at 30 and 60 days post-procedure. Both CardioBip and HM data were reviewed by two independent, blinded cardiologists.
All 21 patients completed the full 60-day follow-up period and showed good compliance throughout, making an average of 2.2 transmissions per day. Twenty of 21 patients had at least one episode of recurrent AF detected by CardioBip. Most of these episodes were asymptomatic. Six of the 20 patients also had occurrence of atrial flutter (AFLT) detected. In contrast, only four and two patients had recurrent AF and AFLT detected by 12-lead HM, respectively. In all these six patients, AF and AFLT had already been detected by CardioBip an average of 27 days earlier than detection by 12-lead HM. All symptomatic CardioBip transmissions were correlated with at least one rhythm irregularity (e.g. AF, AFLT, or premature beats).
Dr. Dorin Panescu, PhD, NewCardio’s Chief Technical Officer, commented, “This is the third clinical study showing that CardioBip is an effective, accurate and patient-friendly solution for long-term monitoring of cardiac conditions. In particular, the study data show that CardioBip has the potential to contribute to clinical management of patients affected by atrial fibrillation.”
Dr. Panescu continued, “NewCardio is committed to strengthening the CardioBip solution and to protecting its respective intellectual property worldwide. In addition to filing several CardioBip-related patent applications with the US Patent Office, NewCardio has aggressively filed respective PCT patent applications and had been issued core CardioBip patents in several other countries.”
Each year, the HRS receives thousands of submissions from outstanding investigators throughout the world, but selects only about one-third for presentation. This is the third successive year that the HRS had invited scientists to present results from studies that used NewCardio’s 3-D ECG solutions.
About the CardioBip
The CardioBip is a unique, hand-held device that provides a solution for ECG telemonitoring. Patients can carry the CardioBip with them and use it to generate and transmit synthesized, accurate 12-lead ECGs at physician prescribed intervals of time, during ordinary daily activity or when symptoms develop. What makes CardioBip unique is its extreme ease of use, combined with the ability to generate recordings substantially equivalent in quality with standard 12-lead ECGs. The CardioBip works without any cables, cumbersome leads, wires or inconvenient skin electrodes, as the device’s electrodes are integrated, offering potential compatibility with popular hand-held PDA platforms. CardioBip is not approved for sale in the U.S.
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.
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.
