Jun 5 2013
Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony® CGM System as a non-invasive, wireless continuous glucose monitoring system, today announced that it is initiating a multi-center clinical trial of its Symphony CGM System to support a CE Mark Technical File for marketing approval in Europe. The Company expects to enroll patients over the coming weeks and announce the results of the study in the third quarter of 2013.
"This clinical study is a milestone event for Echo Therapeutics and we are extremely excited to begin recruitment of patients for enrollment in the trial. It is the final step before the submission of the CE Mark Technical File for potential market clearance and ensuing European commercial launch of Symphony," commented Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "We look forward to providing updates in the near-term as we move toward our goal of making Symphony available to patients."
The clinical study is designed to evaluate the safety and efficacy of the Symphony CGM System in a hospital setting. Glucose data will be collected from thirty-two (32) critically ill patients at four U.S. medical institutions. The Symphony CGM System glucose readings will be paired with reference blood glucose measurements taken from a YSI 2300 STAT Plus Glucose Analyzer.
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