PHILADELPHIA, Jan. 7, 2013 /PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system, today issued the following corporate update to its shareholders:
To Our Shareholders:
As we begin the new year, we are pleased to report that the last year was one of significant accomplishment and progress that has set the stage for a very exciting and productive 2013. In this letter, we would like to reflect on our achievements and, more importantly, look forward to the objectives we intend to achieve in the coming months.
2012 Business Review
Over the past year we achieved several major milestones:
- In 2012, Echo completed two clinical trials of the Symphony tCGM System in critically ill patients that showed that Symphony successfully monitored patient glucose levels and has the potential to be an important tool for the tracking and trending of glucose in the hospital setting. To date, Echo has completed ten pilot studies of the Symphony tCGM System with a combined average error rate (MARD) of 12.0%.
- Echo added key executives to its management team as part of our plan to finalize development and accelerate the commercialization of the Symphony tCGM System and other products contemplated in our growth strategy.
- Echo's Operations management worked closely with the global electronics manufacturing and distribution provider, Benchmark Electronics, Inc., to provide the necessary tools and processes for the product launch of the Symphony tCGM System.
- At the 72nd Annual Scientific Sessions of the American Diabetes Association on June 8, 2012, Echo presented an expanded analysis of data collected from patients with either type 1 or type 2 diabetes during its clinical trial of Symphony. Echo also presented at the 12th Annual Diabetes Technology Meeting on November 9, 2012.
- Echo announced that it obtained several patents throughout the year that provide our products with long-term market protection. Echo holds eight U.S. patents and 71 foreign patents, and has over 25 pending patent applications in the U.S. and foreign countries.
- Three additional analysts initiated research on Echo in 20l2, contributing to improved market awareness. Currently, six investment banks follow Echo: Ascendiant Capital Markets, Feltl and Company, LifeTech Capital, Noble Financial Capital Markets, Northland Capital Markets, and Wunderlich Securities, Inc.
Building on the strong foundation with which we finished 2012, Echo is focused on completing several key milestones during 2013 that will enable us to begin generating revenue.
- Echo expects to achieve International Standards Organization (IS0) 13485 certification in the first quarter of 2013. ISO 13485 is the globally recognized Quality System standard that prescribes consistent processes for the development, design and manufacturing of medical devices, and is considered a step towards securing product commercialization approval by European and other international regulatory agencies.
- Echo is preparing for a multi-center European regulatory trial of the Symphony tCGM System in critically ill patients and a subsequent Conformite Europeenne (CE) Technical File submission in the first half of 2013. CE Marking would enable the commercial sale of Symphony in the EU and other countries that recognize the CE Mark.
- In anticipation of a review of and determination regarding its CE Mark application in the second half of 2013, Echo has begun significant commercial planning activities. Echo is preparing for European launch in target markets by the end of the year.
- Echo is intensifying partnership discussions as Symphony nears commercialization. The company is exploring a variety of partnership opportunities that exist in both the critical care and outpatient settings, and across numerous geographical areas.
- Echo expects to meet with the Food & Drug Administration (FDA) in early 2013 to discuss the proposed pivotal clinical study during a Pre-PMA Submission meeting. We plan to commence the pivotal clinical trial in the second half of 2013. The safety and efficacy data obtained from the pivotal trial are expected to support a Premarket Approval application.
- Echo plans to increase its scientific communication via oral presentations, poster sessions, and exhibitions at major medical meetings in Europe and the U.S., to strengthen awareness in the key opinion leader community.
- Echo will provide continued communication with the investment community through upcoming investor conferences and regular updates on the company's progress.
Thank you for your investment in the continued success of our company. We look forward to keeping you informed of our progress throughout the year.
Patrick T. Mooney, M.D.
Chairman and CEO
About Echo Therapeutics
Echo Therapeutics is developing the Symphony tCGM 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 tCGM System, 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 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 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, 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.
For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
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SOURCE Echo Therapeutics, Inc.