FRANKLIN, Mass., July 1 /PRNewswire-FirstCall/ -- Echo Therapeutics,
Inc. (OTC Bulletin Board: ECTE) announced today that it has initiated a
clinical study of its Symphony(TM) Transdermal Continuous Glucose
Monitoring System (tCGM System) in patients with Type 1 and Type 2
diabetes. The Company expects to complete and announce the results of the
study in the third quarter of 2008. Echo's non-invasive Symphony tCGM
System consists of its Prelude(TM) SkinPrep System, which incorporates
patented and leading-edge skin permeation control technology, and wireless
transmission and proprietary transdermal biosensor technologies. Echo's
Symphony tCGM System is designed to provide both diabetes and hospital
patients with a reliable, needle-free, easy-to-use, affordable and
comfortable-to-wear continuous glucose monitoring device.
"Building on the momentum generated from our prior four positive pilot
clinical studies, we are excited to have started our next pilot study in
the important diabetes home use market. Our new Prelude Skin Prep System is
a competitively unique component of our Symphony tCGM System, enabling our
system to generate painless, needle-free, continuous glucose measurements.
The primary purpose of this new study is to evaluate the performance of our
Symphony tCGM System with Prelude as the new skin permeation element,"
stated Patrick T. Mooney, M.D., Echo's Chairman and Chief Executive
Officer. "We are very excited about our significant development progress
thus far, and we look forward to making additional progress with Symphony
throughout 2008."
Echo's pilot clinical study will enroll ten (10) patients with diabetes
(either Type 1 or Type 2) and will compare data obtained from its Symphony
tCGM System with both the "gold standard" YSI Glucose Analyzer and a
widely-used, commercially available "finger-stick" glucometer. The study
will collect more than 900 data pairs to be used in the analyses. Reference
glucose measurements will be made at 15 minute intervals for 24 hours with
the study data blinded to study subjects and study personnel.
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 patients with diabetes and
for use in hospital critical care units, together with a wide range of
novel topical reformulations of widely-used, 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 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. Furthermore, Echo's tCGM system has not yet
been approved for sale. The regulatory approval process for its tCGM system
involves, among other factors, 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
system 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.
For More Information:
Patrick T. Mooney, M.D. Lilian Stern
Chairman and Chief Executive Officer Stern Investor Relations
(856) 429-8778 (212) 362-1200
SOURCE Echo Therapeutics, Inc.
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CONTACT: Patrick T. Mooney, M.D., Chairman and Chief Executive Officer, +1-856-429-8778, or Lilian Stern, Stern Investor Relations, +1-212-362-1200
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