FRANKLIN, Mass., July 29 /PRNewswire-FirstCall/ -- Echo Therapeutics
(OTC Bulletin Board: ECTE) today announced positive results of a clinical
study of its Symphony(TM) Transdermal Continuous Glucose Monitoring (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 the Prelude(TM) SkinPrep System, which
incorporates leading-edge, needle-free skin permeation control. Echo's
Symphony tCGM System is designed to provide both diabetics and hospital
patients with a reliable, affordable, comfortable-to-wear, and easy-to-use,
needle-free continuous glucose monitoring device.
"This study represents another major advancement in our Prelude and
Symphony development programs," stated Patrick Mooney, M.D., Echo's
Chairman and CEO. "We have now successfully used Prelude, our new
needle-free skin preparation system, in combination with our non-invasive
Symphony tCGM technology. Data from this study demonstrate that Symphony,
using Prelude, is safe, accurate and reliable at monitoring glucose levels.
We look forward to continuing progress with our Symphony development
program throughout the year."
Study Design
After Prelude skin permeation, Symphony tCGM biosensors were applied to
ten 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 observation period, the test skin sites were inspected for
redness or any other undesirable effects.
Analytical Methods
The primary statistical analysis tools used to evaluate the performance
of the Symphony tCGM System relative to the reference measurements were the
Clarke error grid, mean absolute relative difference (MARD) and linear
regression, each of which are 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 zone percentage (closer to
100%) and lower combined D and E zone percentage (closer to 0%) are
considered to have better performance. Continuous Glucose Monitoring (CGM)
system performance, including tCGM system performance, is competitive if at
least ninety-five percent (95%) of the data points fall within the combined
A/B zones, along with negligible or no data points in the combined D/E
zones. Mean absolute relative difference (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. A low MARD
error, below 20%, is generally considered competitive.
Study Results
Using 1,292 reference blood glucose measurements from the ten subjects
in the study, Clarke error grid analysis of the study data showed that
Echo's Symphony tCGM System had approximately 99% of the data in the
combined A/B zones, with 76.4% in the A zone and 22.4% in the B zone, and
only 0.2% and 0.9% in the C zone and D zone, respectively. The MARD for the
study was 13.8%. The correlation coefficient (R) for the data was 0.89.
There were no adverse events reported from Prelude skin permeation or the
Symphony tCGM biosensor.
Conference Call and Webcast Information
Echo will host a conference call today at 11:00 AM ET to discuss the
data from its recent clinical study and to provide an update on its
Symphony development program. To access the conference call, please dial
866-394-4716 (domestic) or 706-634-5164 (international) and reference the
conference ID 58102479. A replay of the call will be available from 12:00
PM. ET on July 29, until August 12, 2008, at midnight. To access the
replay, please dial 800-642-1687 (domestic) or 706-645-9291 (international)
and reference the conference ID 58102479. A live audio webcast of the call
and the archived webcast will be available in the Investors section of the
Echo Therapeutics website http://www.echotx.com .
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 diabetics 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:
Investors, Patrick T. Mooney, M.D., Chairman
& CEO of Echo Therapeutics, +1-508-530-0329; or Melanie Friedman
of Stern Investor Relations, +1-212-362-1200
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