Notified Body Accepts Echo Therapeutics' Clinical Trial Plan for Symphony® CGM System
Data from the trial will support CE Marking
PHILADELPHIA, May 29, 2013 /PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony® CGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system, today announced that it has received agreement from its Notified Body inEurope on its clinical trial plan. Following completion of the clinical trial, the company will submit the analyzed data to the Notified Body in a Technical File in support of its Symphony CE Mark application.
"We are very pleased with the positive outcome of the Notified Body's pre-assessment of our clinical trial plan. We are working very closely with the clinical trial sites as we prepare for the imminent commencement of the study," commented Dr. Mooney, Chairman and CEO of Echo Therapeutics. "Data from this study will support the safety and performance of Symphony needed to obtain marketing approval in Europe."
About Echo Therapeutics
Echo Therapeutics is developing the Symphony CGM System as a non-invasive, wireless, transdermal 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 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 ongoing studies, 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
SOURCE Echo Therapeutics, Inc.