Healthcare Industry News: continuous glucose monitor
News Release - October 6, 2011
Echo Therapeutics Announces Positive Results of Clinical Trial of Its Symphony(R) Continuous Glucose Monitoring SystemPHILADELPHIA, Oct. 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. Data from the study confirm that Symphony successfully monitors patient glucose levels and continues to demonstrate improvements in clinical performance. Echo plans to conduct a study in patients with diabetes during the fourth quarter, followed by a study in critical care patients shortly thereafter.
"The results of this study demonstrate that this next generation of Symphony successfully monitors glucose levels and has the potential to be an important tool for tracking and trending of glucose. The adoption of CGM is growing rapidly in diabetes management, as is frequent glucose testing in critical care patients, as medical literature continues to underscore the need for better glucose control to improve patient outcomes," said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "We are excited about these results and the potential for Symphony and we expect similar, positive results from the two additional studies in diabetics and critical care patients in the coming months."
The feasibility study was designed to evaluate the performance of the Symphony tCGM System. Twelve (12) adult subjects, each without a history of 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 and a commercially available, professional-use glucometer. 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 and professional-use blood glucose test system. 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.
Using over 1,600 Symphony tCGM glucose readings from the 12 study subjects paired with reference blood glucose measurements, CG-EGA showed that 98.3% of the readings were clinically accurate and 1.2% were benign errors with a combined A+B of 99.5%. The MARD for the study was 10.5%. Values for blood glucose measurements ranged from 64 to 212 mg/dL. There were no adverse events reported from the Prelude skin permeation or the Symphony tCGM biosensor.
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 funding 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 Forms 10-Q, and its Current Reports on Forms 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.
Source: Echo Therapeutics
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