NewCardio, Inc., (OTC Bulletin Board: NWCI) a cardiac diagnostic technology provider, today announced that the Company has formally launched its lead product, QTinno(TM), a software suite that provides an automated, comprehensive analysis of cardiac safety for the pharmaceutical industry.
NewCardio's organization has achieved organizational readiness and is now prepared to support clients effectively and efficiently as they implement and use QTinno(TM) in their clinical trials. The Company met stated timeline goals and management expects to build upon recent commercialization successes and anticipates supporting new and existing customers as they initiate fully automated Thorough QT and QT (TQT/QT) trials utilizing QTinno(TM) in the third and fourth quarter of 2009.
Dorin Panescu, PhD, NewCardio's Chief Technical Officer and VP of Research and Development, commented, "The launch of QTinno(TM) is the culmination of our efforts focused on developing and validating the industry's first intelligent automation solution for ECG analysis for clinical drug trials. I believe the initial release of QTinno(TM) delivers a leap forward in terms of accuracy, reproducibility, timeliness and cost in performing cardiac safety analysis in TQT/QT studies."
Currently, every drug in development must undergo studies to determine cardiac toxicity levels. These TQT/QT studies currently involve semi-automated readings by cardiologists assisted by software relying on two-dimensional algorithms. NewCardio's QTinno(TM) solution has the potential to replace this costly, time-consuming and labor intensive process with a fully automated solution which promises higher quality results and a more efficient approach. The Company believes that its QTinno(TM) intelligent automation software solution is the industry's first viable offering for the accurate, automated analysis of ECGs used to determine cardiac toxicity in drug development.
To date, NewCardio has validated QTinno(TM) performance in more than 65,000 ECGs from six drug safety studies, the three largest of which were recent TQT studies. In all of these clinical validation studies, QTinno(TM) demonstrated accuracy and precision equal to or higher than core lab manual readings, and a consistent ability to detect drug induced QT prolongation induced by the moxifloxacin class of drugs, as required by the FDA and other drug regulatory bodies.
Branislav Vajdic, PhD, NewCardio's Chief Executive Officer, added, "The official launch of QTinno(TM) is testimony to NewCardio operational excellence, including the design, implementation and validation of the quality management systems, professional services methodology, sales and marketing strategies, and customer services and information technology infrastructure. I believe that our team offers a combination of medical, technical and operational excellence unparalleled in this industry. This will ensure the success of our customers and partners in the utilization of the NewCardio solutions, specifically QTinno(TM)."
NewCardio has recently experienced a series of successes in adoption by key industry players in the life science market, including a top-five pharmaceutical company. The Company has entered into its first master services agreement for the integration of QTinno(TM) into product and service offerings of a cardiac safety and clinical trials service provider. Management expects to formalize additional agreements as the industry begins to realize the benefits and potential of QTinno(TM) in advancing the current cardiac safety analysis approaches. This expectation is supported by positive feedback from a recent presentation of the QTinno(TM) technology and validation results with the FDA.