PHILADELPHIA, Sept. 8, 2011 /PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing the Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude™ SkinPrep System for transdermal drug delivery, today announced that it is initiating a clinical study of its Symphony tCGM System. The company expects to complete and announce the results of the study in the near-term.
"Initiating the clinical study of this next generation Symphony System is an important milestone for Echo that represents the steady execution of our objectives in pursuit of FDA approval. We are enthusiastic about Symphony's potential based on the results of our six previous trials," said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "We are very excited about our significant development progress thus far, and we look forward to making additional progress with Symphony this year."
Echo's clinical study will enroll healthy volunteer subjects and will compare data obtained from its Symphony tCGM System with both the YSI 2300 STAT Plus Glucose Analyzer and a commercially available professional-use glucometer. The study will collect more than 900 data pairs to be used in the analyses by taking frequent reference glucose measurements for 24 hours. The study data will be blinded to study subjects and study personnel. A comparison of the data relative to the blood glucose values will determine the accuracy of Symphony.
Upon completion of this study, Echo plans to conduct a study in patients with diabetes early in the fourth quarter.
About Continuous Glucose Monitoring (CGM)
Continuous glucose monitoring has the potential to help plan diabetes treatment, guide day-to-day choices about diet, exercise and insulin use, and avoid unwanted low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia) events and the complications that they can cause. Blood glucose levels are affected by many factors such as the carbohydrate and fat content of food, exercise, stress, illness, and variability in insulin absorption among others; therefore, it is often challenging for diabetes patients to avoid frequent and unpredictable excursions above or below normal glucose levels. Patients are often unaware that their glucose levels are either too high or too low, resulting in their inability to control their glucose levels and prevent the complications associated with unwanted glucose excursions.
About Echo Therapeutics
Echo Therapeutics is developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system for patients with diabetes and for use in hospital critical care units. Echo is also developing its needle-free Prelude SkinPrep System as a platform technology for enhanced skin permeation for 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 and its partners' ongoing studies, including the safety and efficacy of Echo's Symphony tCGM and Prelude SkinPrep Systems, 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, 2010, 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, Corporate Communications and IR
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SOURCE Echo Therapeutics, Inc.