FRANKLIN, Mass., Jan. 2 /PRNewswire-FirstCall/ -- Echo Therapeutics,
Inc. (OTC Bulletin Board: ECTE) announced today that it has started the
second clinical study of its current Symphony(TM) Continuous Transdermal
Glucose Monitoring System (CTGM System) at the Tufts-New England Medical
Center (Tufts-NEMC). The Company expects to announce the results of the
study in the first quarter of 2008. Echo's current generation Symphony CTGM
System consists of the FDA-cleared SonoPrep(R) skin permeation device that
incorporates patented and leading-edge permeation control technology,
together with wireless conductivity and proprietary transdermal sensor
technologies. In addition to providing glucose monitoring benefits to
diabetes patients, Symphony is designed to help patients and healthcare
teams in hospital critical care settings to better control glucose levels
with accurate, needle-free, continuous glucose readings.
"We have made significant progress in the development of our core
components of both current and next generation Symphony CTGM Systems. Our
permeation control technology is a competitively unique element of our
non-invasive, transdermal skin permeation approach for the Symphony system.
The primary goal of this study is to expand the strong data set we
generated with our current Symphony CTGM System in our prior study at
Tufts-NEMC, while also focusing on further advancements to our transdermal
sensor technologies we currently expect to bring to market in 2009," stated
Patrick T. Mooney, M.D., Echo's Chief Executive Officer. "We believe that
non-invasive, transdermal continuous glucose monitoring in the critical
care setting is a large and emerging market for Symphony. In addition, we
believe that Symphony will offer diabetes patients in the home use market a
convenient, needle-free and cost-effective continuous glucose monitoring
system to help avoid complications related to poor glycemic control by
providing better predictive information regarding glucose trends. We are
very excited about our progress, and we look forward to important
advancements related to Symphony in early 2008."
Stanley A. Nasraway, M.D., Director of Surgical Intensive Care Units at
Tufts-NEMC and Principal Investigator of the study, noted the following
about the application of Symphony in the hospital setting, "We need to
improve the monitoring of blood glucose, from the current standard of once
every 1-2 hours. It is clear that critical care patients need tighter
glycemic control in order to minimize morbidity and mortality in the
critical care setting. Echo's ability to provide patients a continuous,
needle-free blood glucometry is very attractive. When this happens, blood
glucose measurements will become the 5th Vital Sign, and tighter glycemic
control, without serious hypoglycemia, will be the standard of care for all
seriously ill hospitalized patients, worldwide."
Echo's study at NEMC will enroll twenty-five (25) patients undergoing
cardiac bypass graft surgery and will evaluate the safety and efficacy of
its current generation Symphony CTGM System in a hospital setting by
comparing Symphony's wireless, needle-free, real-time blood glucose (BG)
monitoring to results of traditional BG monitoring in the intra-operative
and post-operative critical care settings. A secondary goal will evaluate
the reliability of Symphony in adverse conditions, such as during
cardioplegia, use of vasopressors, transfused blood elements, diaphoresis,
obesity, hypothermia and significant peripheral edema.
The skin permeation feature of Echo's current generation of Symphony
CTGM System involves SonoPrep, Echo's FDA-cleared device using
ultrasound-mediated skin poration technology. Pursuant to a license
agreement, Echo granted Bayer an exclusive license to the current
generation Symphony CTGM System in the worldwide markets. The parties
subsequently agreed to an amendment to the license agreement whereby Bayer
agreed to a co-exclusive license with Echo to the current generation
Symphony CTGM System in the hospital intensive care unit market. Based on
Echo's recent internal technical advances relating to its next generation
Symphony CTGM System, Echo will expand its offerings of skin permeation
devices beyond its SonoPrep System used in its current generation Symphony
CTGM System. Currently, Echo and Bayer do not intend to utilize ultrasound
techniques for skin permeation in future transdermal glucose monitoring
devices for the home use market. As such, Bayer was not obligated to make a
$2 million milestone payment to the Company on or before December 31, 2007
under Echo's agreement with Bayer. Bayer retains a co-exclusive license to
Echo's current generation Symphony CTGM System using ultrasound skin
permeation techniques in the worldwide markets, but no longer has a right
of first refusal for the marketing of Echo's CTGM System that makes use of
ultrasound skin permeation methods. Bayer does not have commercial rights
to Echo's next generation Symphony CTGM System.
Echo expects to announce its progress with respect to its next
generation Symphony CTGM System, including its advanced skin permeation
strategy, in the first-half of 2008. Echo's discussions with prospective
strategic partners for development and marketing of its next generation
Symphony CTGM System are ongoing.
About Echo Therapeutics
Echo Therapeutics is a platform-enabled specialty therapeutics and
diagnostics company developing a broad pipeline of both advanced topical
reformulations of FDA-approved products using its proprietary AzoneTS(TM)
dermal penetration technology, and Symphony(TM), a next generation
wireless, needle-free, continuous transdermal glucose monitoring (CTGM)
system for the diabetes and hospital critical care markets.
(C) 2008 Echo Therapeutics, Inc., SonoPrep is a registered trademark of
Echo Therapeutics, Inc. All other company, product or service names
mentioned herein are the trademarks or registered trademarks of their
respective owners.
Safe Harbor Statement
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 results of Echo's ongoing studies regarding
the efficacy of Echo's current and next generation Symphony(TM) CTGM
System, which include delays in enrolling patients and volunteers into
clinical studies, lower than anticipated retention rates of patients and
volunteers in clinical studies, the need to repeat clinical studies as a
result of inconclusive or negative results or poorly executed testing,
insufficient supply or deficient quality of product candidate materials or
other materials necessary to conduct clinical studies, serious and
unexpected adverse device effects experienced by participants in clinical
studies, or the suspension of clinical studies, any of which could delay or
prevent commercialization of Echo's Symphony(TM) CTGM System product
candidates; the failure of future development and preliminary marketing
efforts related to Echo's next generation Symphony(TM) CTGM System; risks
and uncertainties relating to Echo's ability to develop, market and sell
diagnostic products based on its skin permeation platform technologies,;
the availability of substantial additional equity capital to support robust
research, development and product commercialization activities; and the
success of research, development, and regulatory approval, marketing and
distribution plans and strategies, including those plans and strategies
related to both Echo's current and next generation Symphony(TM) Continuous
Transdermal Glucose Monitoring System.
These and other factors are identified and described in more detail in
Echo's filings with the Securities and Exchange Commission, including,
without limitation, Echo's respective annual reports on Form 10-KSB for the
year ended December 31, 2006, Echo's most recent quarterly reports on Form
10-QSB, and Echo's 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, MD Laura Perry
Chief Executive Officer Stern Investor Relations
(856) 429-8778 (212) 362-1200
SOURCE Echo Therapeutics, Inc.
back to top
CONTACT: Patrick T. Mooney, MD, Chief Executive Officer of Echo Therapeutics, Inc., +1-856-429-8778; or Laura Perry of Stern Investor Relations, +1-212-362-1200, for Echo Therapeutics, Inc.
|