FRANKLIN, Mass., April 9, 2008 /PRNewswire-FirstCall/ - Echo
Therapeutics (OTC Bulletin Board: ECTE) today announced positive results
from its human feasibility study of the Prelude(TM) SkinPrep System, Echo's
next-generation, needle-free, non-invasive skin permeation medium for its
Symphony(TM) tCGM System, a novel transdermal continuous glucose monitoring
(tCGM) system in development for diabetes home use and hospital critical
care markets. Prelude incorporates Echo's patented skin permeation control
feedback technology into a comfortable, wireless, hand-held device used to
prepare a small area of the skin for the non-invasive, biosensor and
monitoring components of its Symphony tCGM system. Results of the
feasibility study on healthy subjects demonstrate that Prelude safely and
effectively permeated the skin so that the Symphony tCGM System could
continuously monitor blood glucose levels reliably over a 24-hour period.
Echo plans to use Prelude in the remaining pilot and pivotal clinical
studies necessary to commercialize the Symphony tCGM System, including
clinical studies scheduled to begin in the second quarter of this year.
"Painless, needle-free, non-invasive skin permeation is critical to our
development and commercial goals for Symphony. Building on the positive
results from our recently completed Symphony tCGM System study at Tufts
Medical Center, we are pleased to have achieved technical feasibility of
Prelude in humans well ahead of schedule," said Patrick Mooney, M.D.,
Echo's Chairman and CEO. "With Prelude, we now have a needle-free, safe,
effective, easy-to-use and low-cost skin permeation system for Symphony. We
look forward to the results of our near term clinical trials in the
diabetes home use and hospital critical care settings."
"These data demonstrate that Prelude, which incorporates our patented
feedback control mechanism, can achieve precise, individually optimized
skin permeation to enable Symphony to provide users with reliable and
continuous blood glucose information," said Han Chuang, Ph.D., Director of
Research and Development at Echo Therapeutics. "We are very encouraged by
our progress."
Study Design
The feasibility study was designed to evaluate the performance of
Prelude as part of Echo's current generation Symphony tCGM System. Six (6)
adult subjects, each without a history of diabetes, were enrolled. The skin
of each subject was prepared using Prelude and a Symphony tCGM System
biosensor was applied to the skin site. The study subjects were free to
continue their routine activities at home and at work. Blood glucose (BG)
references were taken every hour, or more frequently during the waking
period, for comparison with Symphony results generated from Echo's
past-generation, ultrasound-based skin permeation system. The Symphony
biosensor remained on the patient and analyzed glucose levels for 24 hours.
Study Analytical Methods
Continuous data from the study were compared to reference measurements
from commonly-used glucometers. The reference measurements were paired with
the Symphony results through a data analysis algorithm. The primary
statistical analysis tools used to evaluate the performance of Symphony
were Clarke Error Grid analysis and Mean Absolute Relative Difference
(MARD). The Clarke Error Grid analysis was designed to evaluate the
performance of glucometers and is used as an analytical tool to assess
performance of continuous glucose monitoring (CGM) systems. 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. CGM system performance is generally considered
acceptable if at least ninety-five percent (95%) of the data points fall
within the A/B region, along with negligible or no D/E points. MARD is an
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 device.
Study Results
Using nearly 144 hours of continuous data from Symphony and 183
reference BG measurements from the 6 study subjects in a home use setting
with self-administration, Clarke Error Grid analysis of the study data
showed that Symphony had 100% of the data in the combined A and B regions
with approximately 90% in the "A" region. No data points showed in the C, D
and E regions. The MARD for the study was 9.0%. There were no Prelude or
Symphony failures and no adverse events, indicating strong reliability of
Prelude as the skin permeation medium for Symphony.
About Echo Therapeutics
Echo Therapeutics is focused on 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.
Cautionary Statement Regarding 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 tCGM systems (including the 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 robust 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. Furthermore, Echo's tCGM
systems have not yet been approved for sale. The regulatory approval
process for its tCGM systems involves, among other things, successfully
completing pilot and pivotal clinical trials and obtaining a premarket
approval, or PMA, from the FDA. The PMA process requires Echo to prove the
safety and efficacy of its tCGM systems to the FDA's satisfaction. This
process can be expensive and uncertain, and there is no guarantee that Echo
will be able to submit a PMA for its Symphony tCGM System or that its
Symphony tCGM System will be approved by the FDA in any specific timeframe
or at all. In addition, clinical testing of Echo's products and eventual
commercialization of its products are subject to all of the risks and
uncertainties set forth in its periodic reports filed with the Securities
and Exchange Commission.
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.
(C) 2002 - 2008 Echo Therapeutics, Inc. All rights reserved worldwide.
Investor Relations Contacts:
Patrick T. Mooney, M.D.
Chairman & CEO
Echo Therapeutics
508-530-0329
Lilian Stern
Stern Investor Relations
212-362-1200
SOURCE Echo Therapeutics
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CONTACT: Patrick T. Mooney, M.D., Chairman & CEO of Echo Therapeutics, +1-508-530-0329; or Lilian Stern of Stern Investor Relations, +1-212-362-1200, for Echo Therapeutics
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