Echo Therapeutics, Inc. 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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