FRANKLIN, Mass., July 14 /CNW/ -- Echo Therapeutics (OTC Bulletin Board:
ECTE) 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."
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.
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
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
Investor Relations Contacts:
Patrick T. Mooney, M.D.
Chairman & CEO
Stern Investor Relations
For further information:
For further information: 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