PHILADELPHIA, June 12, 2012 -- Echo Therapeutics, Inc., 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, presented an expanded analysis of data collected from subjects with either type 1 or type 2 diabetes during its recent clinical trial of its Symphony tCGM System. The data were presented during an oral presentation session on Friday, June 8 at the 72nd Annual Scientific Sessions of the American Diabetes Association (ADA) in Philadelphia, PA.
The presentation [ADA abstract 007-OR], entitled "Transdermal Continuous Glucose Monitoring Following Skin Permeation," by Wayne Menzie, Echo's Director of Technology and Clinical Development, provided data from twenty (20) adult subjects with type 1 or type 2 diabetes whose glucose levels were monitored continuously for 24 hours. The key findings include:
Symphony successfully monitors the broad range of blood glucose values seen in people with diabetes.
Using over 2,600 Symphony tCGM glucose readings paired with reference blood glucose measurements, the Mean Absolute Relative Difference (MARD) was 12.6% and the Median Absolute Relative Difference (MedianARD) was 11.8%. The overwhelming majority of sensors had a MARD between 8.0% and 15.9% with an overall MARD of 11.3% and a MedianARD of 10.7%.
The Continuous Glucose-Error Grid analysis (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%.
Values for blood glucose measurements ranged from 42 to 333 mg/dL. Most of the study subjects experienced a large degree of glycemic variability with twelve (12) having a standard deviation of all blood glucose measurements of greater than 40 mg/dL and only four (4) subjects less than 30 mg/dL.
An important component of continuous glucose meter performance, the R deviation is a measurement of rate accuracy that examines the difference between the rate of the reference blood glucose measurements and the calculated rate of the CGM over that same time. In this study, 84.7% of the calculated CGM rates were within + or - 1 mg/dL/min of the reference rate and 96.8% were within + or - 2 mg/dL/min.
Following the oral presentation, Echo hosted a panel discussion on hospital-based glucose control with Key Opinion Leaders (KOLs) in glycemic control. Anthony Furnary, M.D. (Starr-Wood Cardiac Group, Portland, OR), Jeffrey Joseph, D.O. (Thomas Jefferson University Hospital, Philadelphia, PA), Stanley Nasraway, M.D. (Tufts Surgical Center, Boston, MA), and Eileen Donnelly, R.N., B.S.N. (Thomas Jefferson University Hospital, Philadelphia, PA) discussed the need for continuous glucose monitoring in hospitals.
"We are extremely pleased with the outcome of the study and our Research & Development team's progress on Symphony. We believe that Symphony successfully monitors glucose in the challenging diabetes population who experience rapid rates of change and a broad range of glucose levels," said Patrick T. Mooney, M.D., Chairman and Chief Executive Officer of Echo Therapeutics. "Additionally, the KOLs at our symposium confirmed the major need for hospital-based continuous glucose monitoring to better control glucose levels in critically ill patients. We value this opportunity for engagement with the medical community to share the Symphony diabetes and critical care data with experts in the field."
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 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.