PHILADELPHIA, June 5, 2013 /PRNewswire/ -- 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.
About Echo Therapeutics
Echo Therapeutics is developing the Symphony CGM System as a non-invasive, wireless continuous glucose monitoring system. Our target is patients who could benefit from glucose monitoring in the hospital setting, including critical care. Significant opportunity also exists for patients with diabetes to use Symphony in the outpatient setting. Echo is also developing its needle-free skin preparation component of Symphony, the Prelude® SkinPrep System, as a platform technology to enhance drug delivery of topical pharmaceuticals.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts, including statements regarding the timing of patient enrollment and the announcement of study results, 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 the timing of patient enrollment, regulatory approvals and the success of Echo's ongoing studies, including the safety and efficacy of Echo's Symphony CGM System, the failure of future development and preliminary marketing efforts related to Echo's Symphony CGM System, 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 the Symphony CGM System, the availability of substantial additional equity or debt capital 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 CGM System. 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, 2012, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 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
- Health Care Industry