Closer Look: NewCardio's exciting results Print E-mail
By Patrick Crutcher   
Tuesday, 14 December 2010 00:00

icon_watchlistLate last week, NewCardio (OTCBB: NWCI) delivered significant results concering their lead product, QTinno. We believe these results are a significant milestone in the company’s history. Notably, an independent commission(created by the FDA) demonstrated that QTinno showed statistically significant reductions in measurement variability, an important measure of the accuracy of their device. These are important results for a company seeking a leading partner and looking to be a leader in cardiac diagnostics.

NewCardio is an early commercial phase cardiac diagnostic and services company. Their proprietary software platform technologies provide higher accuracy to, and increase the value of, the standard 12-lead electrocardiogram (ECG). NewCardio's three-dimensional 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.

They have 3 game-changing devices/software suites: QTinno, CardioBip, and Cardio3KG. 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. QTinno’s features enable it to accurately identify problematic ECGs and flag them for human overread. CardioBip can radically improve the remote cardiac monitoring process as the first non-invasive, remote, wireless device which delivers accurate 12-lead ECG results. Cardio3KG is expected to significantly improve the diagnosis of cardiac events in an urgent care setting, saving lives and improving clinical outcomes by providing a 3-D analysis of the heart's electrical activity in time and space. Every one of these products offers significant economic and medical benefits that are being recognized as the new standard in the field.

NewCardio presented results from a blinded drug safety study conducted by the Cardiac Safety Research Consortium (CSRC) to evaluate the performance of QTinno™ on its "testing" ECG dataset. This was presented to key representatives from the Food and Drug Administration (FDA), pharmaceutical companies, and academia. The CSRC blinded "testing" dataset, comprised of 11,672 electrocardiograms (ECGs) from the moxifloxacin and placebo arms of a recent parallel-group Thorough QT Study. The CSRC makes its blinded "testing" dataset available to any cardiac safety technology developer who accepts the conditions that the blinded analysis is conducted independently by the CSRC without any company involvement, and that any results obtained will be made public by the CSRC. NewCardio is the first such entity to accept the CSRC conditions and complete the study.The CSRC blinded study results show that QTinno accurately detects moxifloxacin-induced QT interval prolongation with statistically significant and substantial reductions in measurement variability compared to sponsor-submitted data.

NewCardio CEO, Vicent Renz, quoted saying,"Validation of new technologies is critical, and FDA representatives have consistently stated that they are willing to accept clinical results using automated ECG measurements from any validated methodology and the results from all of our validation efforts, which now include this CSRC study, more than meet FDA standards for validation, and as such QTinno is acceptable to the FDA. We believe that there will come a point where, based on the quality of performance, the industry will move from validation to the acceptance of methodologies which not only deliver high quality results, but do so in a more timely and cost effective manner. The blinded CSRC study results reinforce the strength of QTinno's performance with both current and potential customers and, more importantly we believe this clearly establishes the critical role of QTinno as the drug development industry accelerates their adoption of the higher quality, cost effective cardiac safety analysis."

Besides these significant results, management has also been making the rounds this year to educate and encourage support for the use of their products. Notably they spoke at the Cambridge Healthtech Institute (CHI) inaugural conference, had a key publication of a clinical study of the my3KG was published in the leading specialty journal in cardiology and presented study results detailing the superior performance of NWIC’s patented CardioBip technology for remote wireless monitoring and detection of atrial fibrillation(AF). The study results discussed the use of CardioBip for improved AF monitoring and detection. Atrial fibrillation is the most common cardiac arrhythmia(abnormal heart rhythm) and is a substantial economic burden to the health care system.

Earlier in the year, NewCardio was awarded two key patents for their platform. The first was a core patent for CardioBip and, in conjunction with two encouraging validation studies announced on January 5, 2010, validates the CardioBip technology, positioning NewCardio as an emerging leader in remote cardiac monitoring. Additionally, NewCardio received another core patent covering technology relating to NewCardio's anticipated emergency/urgent care solution, Cardio3KG.

NewCardio is ahead of the game here and there really are no other competitors technologically. NewCardio had the confidence to put their device to an unbiased assessment by their peers and it passed with ease. In our view, NewCardio is the leader in the cardiac diagnostic and services industry. Their products have the potential to become a very integrable part of cardiac safety not only in clinical QT safety studies(think hospitals). With the FDA looking more closely at cardiac safety data, we believe NewCardio is poised to benefit from market adoption of their leading technologies to deliver robust and more economical results. These validation results signal that QTinno is the first-in-class device for cardiac safety analysis. A strategic partner in 2011 seems like the next logical step in their evolution.

NewCardio Presents Results for Cardiac Safety Research Consortium Blinded Drug Safety Study QTinno reduces measurement variability and improves data quality in independent validation study -

4Q 2010 Newsletter -

3Q 2010 Financial results -

CardioBip patent PR -

Cardio3KG patent PR -

Disclosure: Long NWCI

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