NewCardio announces two encouraging validation studies related to CardioBip

Jan 6 2010

NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, announced today two encouraging validation studies related to CardioBip(TM), a hand-held patient-activated device for recording and wireless transmission of reconstructed 12-lead ECGs. The studies confirmed the product's ability to accurately provide wireless remote patient monitoring.

As stated previously in regulatory filings, NewCardio, Inc. sponsored two studies that used CardioBip for wireless remote patient monitoring. CardioBip features fully integrated electrodes and requires no wires to acquire the signal. The acquired signals are transmitted via wireless telephony to a call center where 12-lead ECGs are reconstructed using NewCardio-proprietary algorithms.

Dorin Panescu, Ph.D., NewCardio's Vice President and Chief Technology Officer, commented, "These encouraging study results confirm the CardioBip's ability to record, reconstruct and transmit an accurate, high-resolution 12-lead ECG, thereby enabling not only rhythm diagnosis, but also detection of ischemic ECG changes and precise reconstruction of atrial activity. The Heart Rhythm Society (HRS) Expert Consensus recommends ongoing monitoring for up to two years following catheter or surgical atrial fibrillation (AF) ablation procedures, and our results suggest that the CardioBip may prove particularly useful in detecting AF recurrence after such procedures."

The goal of the studies was to validate the performance of the CardioBip-transmitted 12-lead ECGs when compared to conventional 12-lead ECGs. The first study validated the performance in remote monitoring of acute ischemic events. The second study analyzed the use of CardioBip(TM) for remote monitoring of patients undergoing AF treatment. The studies were conducted by the Clinical Center of Serbia and by the Dedinje Cardiovascular Institute, both located in Belgrade, Serbia.

• In the first study, 47 subjects with angiography-documented coronary artery disease were monitored for ST-segment changes during exercise treadmill testing. Conventional 12-lead ECGs were recorded simultaneous with CardioBip transmitted signals prior to and post exercise. Conventional 12-lead ECGs were treated as the gold standard. Two blinded expert cardiologists determined the number of patients with positive events, the number of leads with positive events and identified the lead that displayed most numerous positive events. Based on all these three criteria, independent statistical analyses showed that the detection rate of exercise-induced acute ischemia by the CardioBip system was equivalent to that obtained by conventional 12-lead ECG analysis.
• In the second study, 18 patients with persistent AF undergoing elective electrical DC cardioversion were studied. One to three wireless 12-lead ECG CardioBip transmissions were performed three to seven days before and up to two weeks after cardioversion. Atrial activity seen in the CardioBip transmitted traces was compared to that determined by conventional 12-lead ECGs in both sinus rhythm and AF. The two blinded expert cardiologists analyzed the number of leads with visible P waves, the P wave polarity and the number of leads with clear AF signal. Independent statistical analyses showed that 12-lead ECGs transmitted with CardioBip and conventional 12-lead ECGs had equivalent performance.

Ihor Gussak, MD, NewCardio's Vice President and Chief Medical Officer, added, "The results of these two clinical validation studies are exceedingly positive and confirm the performance of the NewCardio's CardioBip for remote wireless monitoring of patients with coronary disease and atrial fibrillation. At present there is no convenient and reliable method for remote monitoring and detection of either ischemic events or derangements of atrial electrical activity. The CardioBip is convenient hand-held device that patients can carry with them and use to generate and transmit accurate and complete 12-lead ECGs during ordinary daily activity or when symptoms develop. Such capabilities have the potential to significantly improve clinical outcomes for millions of patients with heart disease."

Dr. Branislav Vajdic, Chief Executive Officer of NewCardio, added, "These successful studies are an extraordinary achievement by NewCardio's technical and medical teams, and represent a scientific landmark for the CardioBip. NewCardio is committed to bringing significant value to each of the more than a quarter billion ECGs performed annually, and this announcement validates the confidence we have in our ability to achieve this important goal. Our platform technology supports a wide-range of applications, and we are increasingly proud, and excited about CardioBip's potential role in remote wireless monitoring of millions of patients with heart disease."