FRANKLIN, Mass., July 14 /PRNewswire-FirstCall/ -- 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."
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.
Investor Relations Contacts:
Patrick T. Mooney, M.D.
Chairman & CEO
Echo Therapeutics
508-530-0329
Melanie Friedman
Stern Investor Relations
212-362-1200
SOURCE Echo Therapeutics
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Related links:
http://www.echotx.com
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
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