Echo Therapeutics Announces Positive Results Of A Clinical Study Testing Symphony(TM) TCGM System In Patients With Type 1 And Type 2 Diabetes

Main Category: Diabetes
Also Included In: Clinical Trials / Drug Trials
Article Date: 20 Nov 2009 - 2:00 PST

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Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE), a company developing its needle-free Symphony(TM) tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude(TM) SkinPrep System for transdermal drug delivery, today announced positive results of a clinical study of its Symphony tCGM System in patients with Type 1 and Type 2 Diabetes. Echo's non-invasive Symphony tCGM System consists of its wireless transmission and transdermal biosensor technologies and its Prelude SkinPrep System, which incorporates leading-edge, needle-free, controlled skin ablation. Echo's Symphony tCGM System is designed to provide patients with diabetes and critical care patients with a reliable, affordable, and easy-to-use, needle-free continuous glucose monitoring device. The purpose of the study was to test the performance of its new, improved one-piece, cost-effective and easy-to-use biosensor.

"This study represents another major step forward in our Symphony development program," stated Patrick Mooney, M.D., Echo's Chairman and CEO. "We believe that we have successfully developed a new cost-effective, one-piece biosensor and, with this study, we have demonstrated improvement in the accuracy of our Symphony system glucose readings. Data from this study demonstrates that Symphony, using the new, improved, cost-effective biosensor, is safe, accurate and reliable at monitoring glucose levels. We look forward to continued progress with our Symphony development program throughout this year and next as we move toward our goal of making Symphony available to patients."

Study Design

After Prelude skin ablation, ten (10) Symphony tCGM biosensors were applied to subjects with Type 1 or Type 2 Diabetes. Venous reference blood samples were taken from intravenous lines at 15-minute intervals for 24 hours and measured on a YSI 2300STAT PLUS laboratory analyzer. At the conclusion of the 24-hour study period, the test skin sites were inspected for redness or any other undesirable effects.

Analytical Methods

CGM performance is evaluated with multiple analytical tools, as defined by the Clinical and Laboratory Standards Institute's POCT05-A guideline. The primary metric, used to evaluate clinical accuracy, is the continuous glucose-error grid analysis (CG-EGA). 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 trend vs. the underlying blood glucose fluctuations. 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 the other key method for evaluating CGM performance. The most widely accepted tool is mean absolute relative difference (MARD). MARD is a standard error calculation tool that is used to measure the average absolute value of the relative (or percentage) difference between two measurements.

Study Results

Using approximately 900 Symphony tCGM glucose readings paired with reference blood glucose measurements, CG-EGA revealed that the accuracy of the Echo's Symphony tCGM System, measured as a percentage of accurate readings and benign errors, was 97%. The MARD for the study was 12.89%. There were no adverse events reported from the Prelude skin permeation or the Symphony tCGM biosensor.

About Echo Therapeutics

Echo is developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system for patients with diabetes and for use in acute and critical care. Echo's non-invasive Symphony tCGM System consists of its Prelude SkinPrep System, which incorporates patented and leading-edge skin ablation control technology, and wireless transmission and proprietary transdermal biosensor technologies. Echo's Symphony tCGM System is designed to provide both diabetes and hospital patients with a reliable, needle-free, easy-to-use, affordable and comfortable-to-wear continuous glucose monitoring device. Echo is also developing its needle-free Prelude SkinPrep System for transdermal drug delivery of a wide range of novel topical reformulations of widely-used, FDA-approved products.

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 efficacy of Echo's Symphony tCGM System and Prelude SkinPrep System, the failure of future development and preliminary marketing efforts related to Echo's Symphony tCGM System and Prelude SkinPrep System, Echo's ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo's ability to develop, market and sell diagnostic and transdermal drug delivery products based on its skin ablation platform technologies, including the Symphony tCGM System and Prelude SkinPrep System, 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 System and its Prelude SkinPrep System. 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, 2008, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. Echo Therapeutics, Inc. undertakes no obligation to publicly update or revise any forward-looking statements.

Source: Echo Therapeutics, Inc