Healthcare Industry News: Symphony
News Release - December 6, 2011
Echo Therapeutics Announces Positive Results of Clinical Trial of its Symphony(R) Transdermal Continuous Glucose Monitoring (tCGM) System in Patients With Type 1 and Type 2 DiabetesPHILADELPHIA , Dec. 6, 2011 -- (Healthcare Sales & Marketing Network) -- 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 PreludeŽ SkinPrep System for transdermal drug delivery, today announced positive results from its clinical study of its Symphony tCGM System in patients with type 1 and type 2 diabetes. Data from the study confirm that Symphony successfully monitors the broad range of blood glucose values seen in people with diabetes. Echo also announced that it plans to conduct a study in critical care patients in the near term.
"This study represents another major step in our Symphony development program. We have now shown that Symphony represents a novel approach for the tracking and trending of glucose in patients with diabetes and holds great potential to make a meaningful impact in the management of this growing disease. Importantly, a recent, major U.S. study demonstrated that real-time, continuous glucose monitoring gives people with type 2 diabetes, in addition to those with type 1 diabetes, improved blood glucose control," said Patrick T. Mooney , M.D., Chairman and CEO of Echo Therapeutics. "We are extremely pleased with the outcome of the study and look forward to the continued success of our Symphony tCGM program, including the upcoming trial in critical care patients."
Using over 2,600 Symphony tCGM glucose readings from the twenty (20) study subjects paired with reference blood glucose measurements, CG-EGA showed that 94.4% of the readings were clinically accurate and 2.5% were benign errors with a combined A+B of 96.9%. The MARD for the study was 12.6%. Values for blood glucose measurements ranged from 38 to 399 mg/dL. There were no adverse events reported from the Prelude skin permeation or the Symphony tCGM biosensor.
The feasibility study was designed to evaluate the performance of the Symphony tCGM System in an outpatient setting at a clinical research organization. Twenty (20) adult subjects with type 1 or type 2 diabetes were evaluated. The skin of each subject was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site. Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300 STAT Plus Glucose Analyzer. The study data was blinded to study subjects and study personnel. At the conclusion of the 24-hour 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 a YSI 2300 STAT Plus Glucose Analyzer. Those reference measurements were paired with the Symphony results through a data analysis algorithm. The primary statistical analysis 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 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, 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.
Source: Echo Therapeutics
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