Echo Therapeutics Submits CE Mark Technical File For Its Symphony® CGM System
Published: Jan 13, 2014
PHILADELPHIA, Jan. 13, 2014 /PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE) ("Echo"), a medical device company developing its Symphony® CGM System as a non-invasive, wireless continuous glucose monitoring system, today announced that it has submitted a Conformite Europeenne (CE) Mark Technical File to its European Notified Body to obtain market approval for its Symphony CGM System in the hospital critical care environment. CE Marking indicates a medical device's compliance with European Union (EU) legislation and directives with respect to safety, health, environmental and consumer protection and is necessary for commercialization in countries in the EU. The Company anticipates receiving CE Marking in the 2nd quarter of 2014.
"This filing marks the successful culmination of efforts to execute on the multitude of directives required for an anticipated CE Marking and would not have been possible without the dedication of our team," said Robert F. Doman, Executive Chairman and Interim CEO of Echo Therapeutics, Inc. "With the completion of this important regulatory step, we can now focus on the implementation of the product enhancements essential to the initial European launch, as well as to the planned U.S. pivotal trial. We look forward to providing further updates on our progress as we prepare for a limited launch of Symphony in Europe."
About Echo Therapeutics
Echo Therapeutics is developing the Symphony CGM System as a non-invasive, wireless, continuous glucose monitoring system for use initially in the critical care setting. Significant opportunity also exists for Symphony to be used in the hospital beyond the critical care setting, as well as in patients with diabetes in the outpatient setting.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts, including the statement about the Company's receipt of CE Marking, 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, 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
SOURCE Echo Therapeutics, Inc.
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