Echo Therapeutics Initiates Clinical Trials of its Symphony tCGM System in Critical Care Patients
PHILADELPHIA, Jan. 24, 2012 /PRNewswire/ — Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing the Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude® SkinPrep System for transdermal drug delivery, today announced that it is initiating clinical studies of its Symphony tCGM System in critical care patients. The company expects to complete and announce the results of the studies in the near term.
“We are very excited to initiate patient enrollment in our next studies of the Symphony system in the important hospital critical care setting,” said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. “The goal of these trials is to demonstrate Symphony’s performance in the large and emerging critical care market for non-invasive continuous glucose monitoring. We believe that Symphony addresses this unmet need, potentially improving patient outcomes.”
Echo’s clinical studies will enroll up to thirty (30) critical care patients and will compare data obtained from its Symphony tCGM System with the YSI 2300 STAT Plus Glucose Analyzer. The studies are expected to collect more than 1,000 data pairs to be used in the analyses by taking frequent reference glucose measurements for 24 hours. The data from the studies will be blinded to study subjects and study personnel. A comparison of the data relative to the blood glucose values will be used to assess the accuracy of Symphony.
About Continuous Glucose Monitoring in Critical Care
Hyperglycemia is common in critically ill patients, even in those that do not have a history of diabetes. Intensive insulin therapy and frequent glucose monitoring in critically ill patients has been proven in clinical studies to significantly reduce patient morbidity and mortality. Intensive insulin therapy requires frequent, often hourly, nurse intervention to monitor blood glucose and adjust insulin administration to avoid hypoglycemia. The potential benefits of accurate continuous glucose monitoring in critical care are widely recognized.
About Echo Therapeutics
Echo Therapeutics is developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system for patients with diabetes and for use in hospital critical care units. Echo is also developing its needle-free Prelude SkinPrep System as a platform technology for enhanced skin permeation for delivery of topical pharmaceuticals.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo’s and its partners’ ongoing studies, including: the safety and efficacy of Echo’s Symphony tCGM and Prelude SkinPrep Systems; the failure of future development and preliminary marketing efforts related to Echo’s Symphony tCGM and Prelude SkinPrep Systems; Echo’s ability to secure additional commercial partnering arrangements; risks and uncertainties relating to Echo’s and its partners’ ability to develop, market and sell diagnostic and transdermal drug delivery products based on its skin permeation platform technologies, including the Symphony tCGM and Prelude SkinPrep Systems; the availability of substantial additional funding to support its research, development and product commercialization activities; and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Symphony tCGM and Prelude SkinPrep Systems. These and other risks and uncertainties are identified and described in more detail in Echo’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2010, its Quarterly Reports on Forms 10-Q, and its Current Reports on Forms 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.
For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
SOURCE Echo Therapeutics, Inc.