Newcardio, Inc. (NWCI)

[califax]

QTinno™ -

http://www.newcardio.com/products-qtinno.php

The FDA requires that all new drugs be tested for potential cardiac toxicity early in development. Screening for the risk of drug-induced adverse, often lethal, cardiovascular events – such as those identified with Vioxx®, Seldane®, and Avandia® is of utmost importance for drug developers, and the public health in general. New drugs are often tested on more than 1,000 subjects, with ECGs collected at multiple time points. Current semi-automated methods for arrhythmia induced cardiac toxicity are costly and time-consuming. Using NewCardio’s 3-D approach, drug Sponsors and Contract Research Organizations (CROs) can automate this process, significantly reducing the cost and variability compared with non-automated methods, and reducing the time required to test new drugs in development.

QTinno™ Tools

QTinno™ is a software suite that provides accurate, fully automated and comprehensive analysis of QT intervals, and other ECG markers for cardiac safety assessment in drug development.
Key features

* novel, fully automated assessment tool
* sophisticated, proprietary curve-fitting algorithms to identify key cardiac events
* fast, accurate and precise QT data from a broad range of difficult ECGs, and
* QTinno Client™ provides user friendly software platform for fast, informative human overview of QTinno™ results, if desired.

The QTinno™ algorithm first processes the input signal into a 3D representation of cardiac electrical activity over time. It then generates a "virtual sphere" of normalized cardiac electrical activity that includes balanced and complete information from all parts of the heart. This improves the signal-to-noise ratio and shows difficult-to-detect events with substantially greater clarity than the standard 12-lead display. In addition, QTinno™ incorporates novel curve fitting algorithms that ensure a high degree of accuracy. These advantages enable reliable, fully automated identification of key cardiac events - a problem previously unsolved.

QT Client™

QT Client™, which provides a user friendly software platform for fast, informative overview of QTinno™ results.

The QT Client™ user interface has been carefully designed to meet user needs, both in display and data analysis. Among other things, QT Client™ provides the user with an output that identifies the exact time of all key cardiac events used in analysis – such as Q onset, end of the T wave, heart rate, raw and rate-corrected QT interval, and statistical analysis.

In summary, we believe that for the first time, the definitive solution for automated, thorough or routine QT studies is being offered. QTinno™ by NewCardio will be differentiated in the market by the following features.

* QTinno™ offers productivity and precision of automation and highly accurate results – even on more “difficult” ECGs
* Robust QTinno™ technology potentially adaptable to rapidly emerging problem of drug-induced propensity to increased rates of adverse cardiac events
* NewCardio’s solution provides more accurate, more efficient, lower cost, and lower risk assessments of cardiac safety.

QTinno™ performance was validated using thousands of ECGs. Two drugs under development were evaluated for cardiac toxicity using QT interval change as the marker. Both studies returned remarkable agreement with the gold standard that was generated by extraordinary careful manual or semi-automated reading by multiple highly qualified cardiologists. Peer reviewed publications are in preparation.


A QT Client™ user screen – one of several displays possible for user inspection of QT results.