Clinically Significant Less Pain Reported by Children and Parents after 5
Minute Skin Anesthesia with SonoPrep(R) and Procedure Tray for Topical
Lidocaine
FRANKLIN, Mass., Dec. 14 /PRNewswire-FirstCall/ -- Sontra Medical
Corporation (Nasdaq SC: SONT) announced today the completion of a randomized,
double-blinded placebo-controlled clinical study of 77 children in the
emergency department at the Hasbro Children's Hospital, Providence, RI.
SonoPrep treatment creates imperceptible, reversible micro-channels
through the stratum corneum thereby making the skin permeable to topically
applied drugs. In this study, the SonoPrep ultrasonic device was applied to
the skin for approximately 15 seconds. A 4% topical lidocaine or placebo
cream was applied to the permeated skin site for five minutes. The children
and parents were asked to rate pain on a visual analogue scale. The study
demonstrated a significant reduction in pain experienced by children during IV
catheterization after a five minute application of 4% lidocaine compared to
the placebo cream on SonoPrep treated skin. Parents also perceived a
clinically significant reduction in pain experienced by their children with
the five minute application of lidocaine.
The principal investigator for this study was Dr. Bruce Becker, Attending
Physician at the Department of Emergency Medicine, Rhode Island Hospital and
Assistant Professor at Brown University. "This study demonstrated that rapid
skin anesthesia facilitated with SonoPrep provides real pain relief for
children and less anxiety for parents," stated Dr. Becker. "As existing
topical lidocaine products require 30 to 60 minutes to be effective, their
use, even in children, is limited. Thus SonoPrep has the potential to provide
clinicians a convenient means to achieve rapid skin anesthesia, which is
particularly important in pediatrics, especially for those chronically ill
children who must endure repeated needle sticks and IV therapy."
Thomas W. Davison, Ph.D., Sontra's President and Chief Executive Officer,
stated, "This very important clinical study further demonstrates the clinical
value of SonoPrep, reducing the pain experienced by children during IV
catheterization." "The study also showed that parents who accompany their
children in the emergency room are clearly perceptive to their child's
experience. We are very grateful to the entire staff at the Hasbro Children's
Hospital Emergency Department who with Dr. Sara Skarbek-Borowska conducted
this important study."
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.
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.
Contacts:
Sean Moran, CFO or Evan Smith, CFA / Erica Pettit
Sontra Medical Corporation Financial Dynamics
Tel: 508-553-8850 Tel: 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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