SonoPrep Ultrasonic Skin Permeation Device Enables Continuous Transdermal
Glucose Monitoring
FRANKLIN, Mass., Nov. 1 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq SC: SONT) announced today that clinical results presented
at the Diabetes Technology Meeting held in October in Philadelphia PA,
demonstrate that its continuous non-invasive glucose monitoring system, being
developed in collaboration with Bayer Diagnostics, reliably detected real-time
changes in the blood glucose levels of patients with diabetes. The glucose
flux biosensor measures the continuous flow of glucose through the skin, which
is made permeable with the SonoPrep(R) ultrasonic skin permeation device.
The study, conducted at Vanderbilt University, included twelve adult
participants with either Type 1 or Type 2 diabetes. Each participant had three
glucose flux biosensors placed on their skin, allowing glucose measurements to
be collected every five seconds over an eight hour period. To challenge the
glucose flux biosensor's accuracy in detecting rapidly changing blood glucose
levels, the blood glucose of each patient was increased or decreased through
the intravenous administration of insulin or glucose in a controlled manner at
rate of change at least two times greater than the usual rate experienced by
patients with diabetes. Over 2,000 data points were evaluated per glucose
biosensor. As a reference, blood glucose measurements were collected from an
intravenous catheter. Completed data sets from the glucose flux biosensors
showed a 90 percent correlation (r = .90) to reference blood glucose
measurements. The glucose flux biosensor was able to reliably predict
hypoglycemia (blood glucose<70 mg/dl) with 96% specificity and 77%
sensitivity. The accuracy of the glucose flux biosensor was compared to
Medtronic MinMed implanted CGMS sensors (n=23) and Cygnus Glucowatch-2(n=13),
which had correlations to reference blood glucose measurements of 82 %( r =
.82) and 70% (r. = .70), respectively.
"We are very pleased with the results of this study because it showed that
our continuous non-invasive glucose monitor detects rapidly changing blood
glucose over a very wide range," stated Thomas W. Davison, PhD, Sontra's
President and Chief Executive Officer. "Over the past year, Sontra scientists
have greatly improved the performance of the glucose flux biosensor. Not only
did the glucose flux biosensor detect rapid changes, it was also able to
detect hypoglycemic conditions, which has been a limitation of other
continuous glucose monitors. We are excited about our glucose monitoring
system because of its promise to address the major unmet market need for a
truly continuous and non-invasive product in the rapidly growing $5 billion
glucose monitoring market."
For a copy of the poster that was presented at the Diabetes Technology
meeting:
http://www.sontra.com/pdfs/glumonihumanclinicalres_pres@diabtechmeetingoct2004.pdf
About Sontra Medical Corporation (http://www.sontra.com)
Sontra Medical Corporation is a leading developer of transdermal drug
delivery and diagnostic products that combine Sontra's SonoPrep ultrasound-
mediated skin permeation technology with synergistic biosensor and transdermal
drug delivery technologies. Sontra is marketing the SonoPrep device and
procedure tray for use with topical lidocaine to achieve rapid (within five
minutes) skin anesthesia. Products under development include: a continuous
non-invasive glucose monitor developed in collaboration with Bayer Diagnostics
and the use of SonoPrep for the transdermal delivery of vaccines, pain drugs
and large protein biopharmaceuticals.
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.
This press release contains forward-looking statements, which address a
variety of subjects including, for example, the expected development, benefits
and efficacy of the SonoPrep device and continuous glucose monitoring system,
the expected benefits, market opportunities and market acceptance of the
SonoPrep device and continuous glucose monitoring system, the expected size of
the markets for the SonoPrep device and continuous glucose monitoring system,
and Sontra's business, research and marketing 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: adverse results in product
development, clinical trials, commercialization efforts and market acceptance;
difficulties or delays in obtaining regulatory approvals to market products
resulting from development efforts; failure to obtain and maintain patent
protection for discoveries; commercial limitations imposed by patents owned or
controlled by third parties; dependence upon strategic partners and third-
party distributors to develop, commercialize, market and sell products based
on our work; the commercial success of products; and the requirement for
substantial funding to conduct research and development and to expand
commercialization 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.
Contacts:
Sean Moran, CFO or Evan Smith, CFA / Erica Pettit
Sontra Medical Corporation KCSA Worldwide
Tel: 508-553-8850 Tel: 212-896-1251 / 212-896-1248
SOURCE Sontra Medical Corporation
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Related links:
http://www.sontra.com
CONTACT:
Sean Moran, CFO of Sontra Medical
Corporation, +1-508-553-8850; or Evan Smith, CFA,
+1-212-896-1251, or Erica Pettit +1-212-896-1248, both of KCSA
Worldwide
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