PHILADELPHIA, May 2, 2012--Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system and its Prelude® SkinPrep System for transdermal drug delivery, today announced positive results from its clinical trial of the Symphony tCGM System in elective cardiac surgery patients. This study is the first of two studies Echo is conducting in critically ill patients, with results from the second study expected later this quarter.
Data from this study demonstrate that Symphony successfully and continuously monitored glucose levels in the cardiothoracic surgical intensive care unit at Tufts Medical Center in Boston, Massachusetts. Data analysis demonstrated that Symphony read glucose levels accurately, with a mean absolute relative difference (MARD), or error rate of 12.3%.
"Echo's data are extremely exciting in light of anticipated recommendations regarding glucose monitoring accuracy performance. Symphony's accuracy in this study strongly suggests that it is within the expected recommendation that accuracy for intermittent blood glucose measurements in critically ill patients should be less than 12.5% error," said Stanley A. Nasraway, Jr., M.D., Director of Surgical Intensive Care Units at Tufts Medical Center and the Principal Investigator of the Tufts study. "Echo's study has produced compelling clinical evidence that this continuous technology can be used for safely sustaining glucose levels within a target range in acutely ill patients. Given the ease of use of this system and the potential cost-savings to hospitals it is likely that Symphony would transition with critically ill patients from the Intensive Care Units to the hospital general floors where better glucose control through technology-assistance is desperately needed in a setting of fewer nursing resources."
Using over 540 Symphony tCGM glucose readings from fifteen (15) study subjects paired with reference blood glucose measurements, CG-EGA showed that 99.6% of the readings were clinically accurate and 0% were benign errors with a combined A+B of 99.6%. The MARD for the study was 12.3%. There were no adverse events reported from the Prelude skin preparation or the Symphony tCGM biosensor.
This study was the first of two studies designed to evaluate the performance of Echo's current generation Symphony tCGM System in the critical care setting. The study was performed at Tufts Medical Center and enrolled fifteen (15) adult patients scheduled for elective cardiac surgery. The skin of each patient was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site prior to surgery. Reference blood samples were taken from arterial line catheters at 30-minute intervals and measured on a YSI 2300 STAT Plus Glucose Analyzer. The data collected by Symphony was blinded to study subjects and Tufts clinical staff. At the conclusion of the study period, the test skin sites were inspected for redness or other undesirable effects.
Continuous data from the Symphony tCGM System were compared to reference measurements from the YSI 2300 STAT Plus Glucose Analyzer. Those reference measurements were paired with the Symphony results through a data analysis algorithm. The primary statistical analytical tools used to evaluate the performance of Symphony were the Continuous Glucose-Error Grid analysis (CG-EGA) and Mean Absolute Relative Difference (MARD). The CG-EGA is a categorization of all data pairs based on the clinical significance of the accuracy. Accurate readings result in the same clinical decision when based on the CGM value versus the blood glucose value. Benign errors lead to the same clinical outcome as accurate readings even though the actual clinical decision may differ. Erroneous readings lead to clinical errors. CGM performance is measured as the sum of accurate readings and benign errors. Numerical accuracy is measured using MARD, an error calculation tool that was used to measure the absolute value of the average relative difference between Symphony measurements and the reference measurements, on a percentage basis.
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, 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