Philadelphia-based Echo Therapeutics (NSDQ:ECTE) is aiming for CE Mark approval in the European Union for its non-invasive, wireless Symphony continuous glucose monitoring system.
The company today announced the launch of a multi-center clinical trial in support of CE Mark submission to European regulators, expecting results in the 3rd quarter of 2013. The study will evaluate the transdermal Symphony monitoring device in a hospital setting.
"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," chairman & CEO Dr. Patrick Mooney said in prepared remarks. "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."
The trial will include data from 32 critically ill patients at 4 U.S. hospitals, according to a press release.
ECTE shares were up 3.4% to 55¢ as of about 1 p.m. today.
