FRANKLIN, Mass., July 14 /PRNewswire-FirstCall/ -- Echo Therapeutics today announced publication of results from three pilot clinical studies of its Symphony Transdermal Continuous Glucose Monitoring (tCGM) System in the Journal of Diabetes Science and Technology. The article highlights that each of the three pilot clinical studies produced positive results supporting the use of Echo’s Symphony(TM) tCGM System for reliable, non-invasive, real-time continuous glucose monitoring, and its most recently developed skin permeation device, the Prelude(TM) SkinPrep System.
“The data from our pilot feasibility studies to date support our late- stage development programs of our Symphony tCGM System for use in diabetes and hospital markets,” stated Patrick Mooney, M.D., Echo’s Chairman and CEO. “We have made substantial progress with Symphony over the past nine months. This article emphasizes that progress and the potential of our Symphony System to assist diabetics and healthcare professionals to improve glycemic control and reduce the rate of short- and long-term complications.”
“Tight glycemic control through continuous glucose monitoring is essential for patients in diverse settings, including for both diabetics at home and hospitalized patients in critical care conditions,” said Stanley Nasraway, M.D., Director of Surgical Intensive Care Units at Tufts Medical Center, Principal Investigator and corresponding author of the published studies. “The Symphony tCGM System, with continuing development, offers a potentially safe and efficacious option that is non-invasive and easy to use in both settings.”
Study Design
Transdermal continuous glucose monitors were applied to patients with diabetes (Study I), patients undergoing cardiac surgery (Study II), and healthy volunteers (Study III). Reference blood glucose measurements were performed with glucometers or standard blood glucose analyzers. At the conclusion of the 24-hour studies, the data were post-processed for comparison with the reference blood glucose values collected during the study periods. Data were validated for ten subjects for 12 hours in Study I, eight subjects for 24 hours in Study II and in Study III.
Analytical Methods
The primary statistical analysis tool used to evaluate the performance of the Symphony tCGM System relative to the reference measurements was the Clarke error grid, which has been widely used to evaluate the performance of glucometers. The Clarke error grid is a plot of all data pairs categorized into five discrete areas: A, B, C, D and E. The A and B areas are the most clinically desirable zones and D and E are the least clinically desirable zones. Devices with a higher combined A and B percentage (closer to 100%) and lower combined D and E percentage (closer to 0%) are considered to have better performance. Continuous Glucose Monitoring (CGM) system performance, including tCGM system performance, is generally considered acceptable if at least ninety-five percent (95%) of the data points fall within the combined A/B region, along with negligible or no data points in the combined D/E region. Mean absolute relative difference (MARD) is a standard error calculation tool that was used to measure the average relative difference between Symphony and the reference measurements, on a percentage basis. A low MARD error, below 20%, is generally accepted to be consistent with an accurate and reliable monitoring device.
Study Results
Comparing predicted glucose versus reference blood glucose values, Study I yielded 89.6% in Zone A and 9.0% in Zone B in the Clarke error grid (222 data points), Study II yielded 86.4% in Zone A and 13.6% in Zone B (147 data points), and Study III yielded 89.9% in Zone A and 10.1% in Zone B (378 data points). Each of the three studies yielded positive results, with combined A and B percentages of 98.7%, 100%, and 100% in Study I, II, and III, respectively. Overall MARD values of the three independent studies were between 9.0% and 12.4% -, reflecting the good accuracy and reliability of the Symphony tCGM System.
About Echo Therapeutics
Echo Therapeutics is focused on transdermal medical devices and specialty pharmaceuticals. Echo is developing a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system for people with diabetes and for use in hospital critical care units, together with a wide range of novel transdermal reformulations of FDA-approved products.
Forward Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward- looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks related to regulatory approvals and the success of Echo’s ongoing studies regarding the efficacy of Echo’s Symphony tCGM System, the failure of future development and preliminary marketing efforts related to Echo’s tCGM systems, risks and uncertainties relating to Echo’s ability to develop, market and sell diagnostic products based on its skin permeation platform technologies, including the 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, and regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its tCGM systems.
These and other factors 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-KSB for the year ended December 31, 2007, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. The foregoing list of factors is not exhaustive. Echo Therapeutics, Inc. undertakes no obligation to publicly update or revise any forward-looking statements.
CONTACT: Patrick T. Mooney, M.D., Chairman & CEO of Echo Therapeutics,
+1-508-530-0329; or Melanie Friedman of Stern Investor Relations for Echo
Therapeutics, +1-212-362-1200
Web site: http://www.echotx.com/
