November 14, 2008
MILWAUKEE, WI, November 14, 2008 - Today Mortara Instrument announced the extension of its Cooperative Research and Development Agreement (CRADA) with the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Under this extension, Mortara will continue to provide on-going development enhancements to the ECG Warehouse, which is used to store and review ECG submissions associated with new drug applications.
Mortara has a long-standing relationship with the FDA, providing ECG algorithm tools and data warehousing solutions to support the Agency's regulatory review of cardiac safety data. Since 2006, the FDA has been using the ECG Warehouse and toolset to review all Thorough QT Trials submitted to them. To accelerate the FDA review process, the ECG Warehouse incorporates Mortara's VERITAS™ ECG algorithms which analyze and quantitatively evaluate the submitted ECG data. Today the ECG Warehouse contains over 2.5 million ECGs, all of which have been automatically analyzed by the VERITAS algorithms.
Dr. Justin L. Mortara, CEO of Mortara Instrument, commented, "We are pleased to move forward in our collaboration with the FDA. With the experience of applying our VERITAS algorithms over millions of ECGs in the ECG Warehouse and thousands of continuous 12-lead recordings outside of the ECG Warehouse, we see opportunities to further enhance the tools utilized by FDA reviewers as well as to expand the horizon of our automatic algorithm offerings. We are fortunate to have worked closely with the FDA over the years and believe we will continue to benefit from this interaction, learning what specific needs the regulators perceive in the world of ECG."
Enhancements planned for the ECG Warehouse include support for longer ECG records, as well as the incorporation of additional VERITAS scoring criteria. These developments reflect the trend in ECG data collection to move beyond discrete ECG acquisition and analysis and toward continuous ECG acquisition and analysis. Mortara Instrument is a leading provider of continuous ECG acquisition and analysis tools, including the Mortara H12+™ Holter recorder and Surveyor™ 12-lead Telemetry System. For additional information on the ECG Warehouse, please see www.ecgwarehouse.com
About Mortara Instrument, Inc.
Mortara Instrument's headquarters are located in Milwaukee, Wisconsin with operations in Italy, Germany, Australia, and the Netherlands. Mortara Instrument is distinguished in the field of non-invasive cardiology innovations that are the core of the company's complete line of ECG products including electrocardiographs, stress exercise systems, Holter systems, data warehousing solutions, and cardiology monitoring systems. Mortara Instrument manufactures and distributes its ECG devices and related technology worldwide. The company's website is www.mortara.com
Mortara Instrument Media Contact: Aimee Kops, (414) 354-1600; firstname.lastname@example.org