First Clinical Evaluation of SonoPrep to Accelerate Topical Anesthesia in
Young Children
FRANKLIN, Mass., Jan. 26 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq SC: SONT) announced today the completion of the first
clinical evaluation of the SonoPrep(R) device in a clinical study of 70 young
children, ages 3 to 7. This was a single-center prospectively controlled
study designed to show that the analgesic effect of a 5-minute application of
LMX Lidocaine Anesthetic Cream after ultrasonic pretreatment was equivalent to
a 30 minute application of LMX, in children presenting for venipuncture at an
urban out-patient phlebotomy clinic. The child rated the pain of their
experience, and the parent rated assessment of their child's pain from the
needle procedure.
Dr. William Zempsky, associate director of the Pain Relief Program at
Connecticut Children's Medical Center, was the Principle Investigator for this
study. Dr. Zempsky is a recognized pediatric pain specialist, and has long
advocated more diligent efforts to control acute and chronic pain in pediatric
patients.
Dr. Zempsky commented, "It is essential that clinicians anticipate the
pain of even the most routine needle procedures in this young population in
order to more effectively manage the discomfort experienced by children. We
have evaluated a number of interventions to facilitate routine adoption of
pre-emptive measures to control pain. Reducing the time to anesthetic effect
should make the task of managing routine needle stick pain more feasible
across a wide variety of busy pediatric clinics."
"The smooth implementation and concise timeline under which this study was
conducted substantiates the level of excellence Dr. Zempsky and his staff are
known for, and demonstrates a genuine commitment on the part of Connecticut
Children's Medical Center to provide the highest level of care for their
patients," said Barry Marston, Sontra's Vice President of Sales and Marketing.
"We are currently summarizing the results from this study, and this data,
together with the other completed studies, as well as ongoing and planned
clinical trials, provides nurses and our growing distribution network with
guidelines for use of our technology and proof of its benefits for children in
all needle stick procedures and clinical settings". Mr. Marston added
"SonoPrep and the Procedure Tray for topical anesthesia are now available
through specialty distributors to hospitals and clinics in most areas of the
country".
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 has demonstrated strong results from its
initial human clinical trials at leading universities and medical centers for
several billion dollar market opportunities including the transdermal delivery
of vaccines and large molecule drugs and continuous non-invasive glucose
monitoring. Sontra is currently marketing the SonoPrep device and procedure
tray for use with topical lidocaine to achieve rapid (within five minutes)
skin anesthesia.
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 efficacy of the
SonoPrep device in connection with diagnostics, vaccine delivery, glucose
monitoring and transdermal drug delivery, the expected benefits, market
opportunities and market acceptance of the SonoPrep device and technology, the
expected size of the markets for the SonoPrep device and technology, Sontra's
expected ability to commercialize additional products, and Sontra's business,
research and marketing strategies and product development plans. 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; difficulties or delays associated
with sources of transdermal drugs and vaccines; 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.
Sontra Contacts:
Sean Moran or Evan Smith, CFA / Erica Pettit,
Sontra Medical CFO Financial Dynamics
508-553-8850 ext 234 212-850-5606 / 212-850-5614
SOURCE Sontra Medical Corporation
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Related links:
http://www.sontra.com
CONTACT:
Sean Moran, Sontra Medical CFO,
+1-508-553-8850 ext 234; or Evan Smith, CFA, +1-212-850-5606, or
Erica Pettit, +1-212-850-5614 both of Financial Dynamics
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