Sontra's Glucose Flux Sensor is the first transdermal system validated for
24 hours
FRANKLIN, Mass., July 25 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq: SONT) announced today the completion of the first
clinical study to verify the performance of its Continuous Transdermal
Glucose Monitor (CTGM). Preliminary analysis of results demonstrated that
the wireless glucose flux sensor accurately detected transdermal glucose to
predict real-time changes in blood glucose levels for 24 hours. The primary
goals of the study were to validate the design and operation of the
wireless sensor and monitor system and collect data sets that will lead to
the development of a blood glucose prediction algorithm. The Sontra CTGM is
being developed to monitor blood glucose of patients in the hospital
intensive care unit. The ICU market for CTGM is more than $1 billion. The
system consists of a bedside monitor that updates blood glucose values
every minute, provides a graphic display of blood glucose trends and the
rate of change in blood glucose. Single patient use glucose flux sensors
are placed over the Sontra SonoPrep(R) treated skin sites. The sensor is
covered with a miniature analyzer that converts the continuous analogue
signal to digital data that is sent wirelessly to the monitor for
continuous monitoring of glucose levels. Regularly monitoring blood glucose
levels has become a necessary procedure performed by ICU personnel to
achieve tight glycemic control and ensure improved patient outcomes.
Sontra's CTGM system was tested on ten healthy volunteers and ten
patients with Type 1 and Type 2 diabetes at an independent lab. Healthy
volunteers were enrolled first to develop implementation guidelines and
validate hardware design and performance. Enrollment of patients with
diabetes followed the implementation of several hardware design changes.
These subjects stayed in the clinic for the duration of the 24 hour study
to mimic hospital in-patient conditions and facilitate investigator
observation. The glucose flux sensor signal was compared to finger stick
blood glucose meter readings. Currently, 320 data points from these
patients are being analyzed to support development of the blood glucose
prediction algorithm. Preliminary analysis of data using individually
optimized algorithms showed a 13.31 MARD with 98.9% of the data in the A-B
region of the Clarke error grid with 84.7% in the A region. Completed data
sets from the glucose flux biosensors showed an 82 percent correlation (r =
.82) to reference finger stick blood glucose measurements.
"This study is the culmination of discovery and innovation by Sontra's
multidiscipline team of scientists and engineers," stated Thomas W.
Davison, PhD, Sontra's President and Chief Executive Officer. "Now we are
preparing to initiate clinical studies on patients in critical care
settings to demonstrate the promise of Sontra's technology to address the
major unmet clinical need for a continuous and non-invasive blood glucose
monitor to support intensive insulin therapy. Everyone at Sontra feels
privileged to be working on such an important advance that will help
critical care physicians and nurses reduce mortality and morbidity for
their patients."
About Sontra Medical Corporation (http://www.sontra.com)
Sontra Medical Corporation is a technology leader in transdermal
science. Sontra's SonoPrep ultrasound-mediated skin permeation technology
combined with technical competencies in transdermal drug formulation,
delivery systems and biosensors is creating a new paradigm in transdermal
drug delivery and diagnosis. The SonoPrep technology is being developed for
several billion dollar market opportunities, including continuous glucose
monitoring and the transdermal delivery of large molecule drugs and
vaccines. Sontra is currently marketing the SonoPrep device and procedure
tray for use with topical lidocaine to achieve rapid (within five minutes)
skin anesthesia.
This press release contains forward-looking statements, which address a
variety of subjects including, for example, the expected technological
advances and availability of the second-generation SonoPrep device, the
expected benefits and efficacy of the SonoPrep device in connection with
diagnostics, vaccine delivery, glucose monitoring and transdermal drug
delivery, Sontra's expected ability to develop, market and sell products
based on its technology, including a continuous transdermal glucose monitor
for the hospital ICU market; the expected market opportunities,
distribution and market acceptance of the SonoPrep device and technology,
the expected size of the market for the continuous transdermal glucose
monitor for the hospital ICU; and Sontra's business, research, product
development, regulatory approval, marketing and distribution plans and
strategies. Statements that are not historical facts, including statements
about our beliefs and expectations, are forward-looking statements. Such
statements are based on our current expectations and are subject to a
number of factors and uncertainties, which could cause actual results to
differ materially from those described in the forward-looking statements.
The following important factors and uncertainties, among others, could
cause actual results to differ materially from those described in these
forward-looking statements: our technology is new and we may experience
adverse results in research and development efforts, product development,
clinical trials, product evaluations, commercialization efforts, product
distribution and market acceptance; markets for our products may develop
slower than expected, or not at all; our sales cycle is lengthy and we are
still developing sales and marketing strategies which may or may not prove
effective; the SonoPrep device may not prove effective in connection with
diagnostics, vaccine delivery, glucose monitoring and/or transdermal drug
delivery; we may experience difficulties or delays in obtaining regulatory
approvals to market products resulting from development efforts or
difficulties or delays associated with sources of regulatory-approved
transdermal drugs and vaccines; failure to obtain and maintain patent
protection for discoveries or commercial limitations imposed by patents
owned or controlled by third parties would have an adverse effect on us; we
depend upon strategic partners and third-party distributors to develop,
commercialize, market and sell products based on our work; and we require
substantial additional funding to conduct research and development and to
expand commercialization, distribution and marketing activities. For
detailed information about factors that could cause actual results to
differ materially from those described in the forward-looking statements,
please refer to Sontra's filings with the Securities and Exchange
Commission, including Sontra's most recent Quarterly Report on Form 10-QSB.
Forward-looking statements represent management's current expectations and
are inherently uncertain. We do not undertake any obligation to update
forward-looking statements made by us.
SonoPrep is a registered trademark of Sontra Medical Corporation. All
other company, product or service names mentioned herein are the trademarks
or registered trademarks of their respective owners.
Investor Relations Contacts:
Barry Marston, VP Sales & Marketing
508-530-0332
bmarston@sontra.com
Harry G. Mitchell, CFO
508-530-0311
hmitchell@sontra.com
SOURCE Sontra Medical Corporation
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Related links:
http://www.sontra.com/
CONTACT:
Investor Relations: Barry Marston, VP Sales &
Marketing, +1-508-530-0332, bmarston@sontra.com, or Harry G.
Mitchell, CFO, +1-508-530-0311, hmitchell@sontra.com, both of
Sontra Medical Corporation
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