FRANKLIN, Mass., March 13 /PRNewswire-FirstCall/ -- Echo Therapeutics
(OTC Bulletin Board: ECTE) today announced positive results from its
clinical study of the Symphony(TM) tCGM System, a novel, non-invasive,
transdermal continuous glucose monitoring (tCGM) system, conducted at the
Tufts Medical Center in Boston, Massachusetts (Tufts). Echo is developing
the Symphony tCGM System to provide patients with diabetes and healthcare
professionals with a reliable, needle-free, wireless, continuous monitoring
system to better manage diabetes and control blood glucose levels in the
home use and hospital critical care settings. Data from the pilot study
demonstrate that Symphony safely and reliably monitored blood glucose
levels in the challenging operating room and surgical intensive care unit
at Tufts. Echo is planning to present these data at a major medical
conference later this year.
"We are proud to be the first company to report positive clinical data
on a non-invasive, transdermal continuous glucose monitoring system in the
hospital critical care setting," stated Patrick Mooney, M.D., Echo's
Chairman and CEO. "We are excited about the potential for our program in
this area and look forward to continued progress with tCGM in both the home
and hospital settings, with further studies planned throughout 2008."
"Critically ill patients need tighter glycemic control to minimize
morbidity and mortality," said Stanley Nasraway, M.D., Director of Surgical
Intensive Care Units at Tufts and the Principal Investigator of the study.
"These data serve as a strong signal that Symphony could advance the
standard of care regarding tight glycemic control in the hospital critical
care setting, much like continuous electrocardiographic monitoring and
pulse oximetry changed standards of care in that setting. This approach
could provide doctors and nurses with breakthrough continuous blood
glucometry technology and significantly improve our ability to monitor
glucose levels of seriously ill patients in the intense intra-operative and
post-operative settings."
Study Design
The pilot study was designed to evaluate the performance of Echo's
current generation Symphony tCGM System, including the use of its
ultrasound-based skin permeation system and newly-improved biosensor
technology incorporating proprietary hydrogel chemistry. The study was
performed at Tufts and enrolled twenty-five (25) adult patients scheduled
for elective cardiac surgery. The study included both intra-operative and
post-operative continuous monitoring of blood glucose (BG) levels. Two
biosensors were applied to each subject, one prior to surgery and one after
surgery. Both Symphony sensors remained on the patient for 24 hours. BG
levels were monitored per the established protocol of Tufts. The
participating subjects and the Tufts medical staff were blinded to data
collected by the Symphony monitor.
Analytical Methods
In this trial, the continuous data were compared to reference
measurements from blood analyzers, glucometers and lab results based on the
Tufts glucose monitoring protocols. Those reference measurements were
paired with the Symphony results through a data analysis algorithm. The
primary statistical 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 monitors. 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. Monitor 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 measures the average
relative difference between Symphony and the reference measurements, on a
percentage basis. A low MARD error, below 20%, is consistent with an
accurate device.
Results
Using approximately 1200 hours of continuous data from Symphony and 482
reference BG measurements from the 25 subjects, Clarke Error Grid analysis
of the study data showed that Echo's Symphony had over 97% of the data in
the combined A and B areas with approximately 70% in the "A" region, 27% in
the "B" region, and less than 3% in the "D" region. The MARD for the study
was approximately 16%. A total of forty-nine (49) Symphony sensors were
used during the study. There were no Symphony failures and no adverse
events, indicating strong reliability of the Symphony for applications in
the hospital critical care setting.
Conference Call and Webcast Information
The Company will host a conference call at 10:30 AM ET to discuss the
data and an update of its pipeline. To access the conference call, please
dial 866- 467-0407 (domestic) or 706-902-0164 (international) and reference
the conference ID 39282879. A replay of the call will be available from
10:30 a.m. ET on March 13, until March 15, 2008, at midnight. To access the
replay, please dial 800-642-1687 (domestic) or 706-645-9291 (international)
and reference the conference ID 39282879. 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 specialty pharmaceuticals and medical
devices. Echo is developing novel topical reformulations of FDA-approved
products and non-invasive, wireless, transdermal continuous glucose
monitoring (tCGM) systems for people with diabetes and for use by
healthcare professionals in hospital critical care units worldwide.
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, 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, 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 Echo's tCGM systems. Furthermore, Echo's transdermal continuous
glucose monitoring systems have not yet been approved for sale. The
regulatory approval process for its tCGM systems involves, among other
things, successfully completing 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, 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.
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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Related links:
http://www.echotx.com
CONTACT:
Investor Relations, 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
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