PHILADELPHIA, March 15, 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 been granted International Standards Organization (ISO) 13485:2003 certification of its quality management system, an internationally recognized quality standard for medical devices.
ISO 13485:2003 is an internationally recognized standard that prescribes consistent processes for the development, design and manufacturing of medical devices. Certification to the ISO 13485 standard represents an important step toward attaining European CE Mark approval for the Company's break-through technology.
"This achievement demonstrates Echo's continued commitment to meeting and exceeding the high standards required of medical device companies selling into Europe," said Stephen Perez, Echo's Vice President of Quality Assurance. "We believe that receiving ISO 13485 certification is a significant accomplishment and an important milestone as we approach the European pivotal trial and commercialization of our Symphony CGM System."
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, 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 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 CGM and Prelude SkinPrep Systems, 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 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, 2011, 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.
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SOURCE Echo Therapeutics, Inc.