Sontra Medical Completes Pediatric Clinical Study Of SonoPrep
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 / 212-850-5614Sontra Medical Corporation
CONTACT: Sean Moran, Sontra Medical CFO, +1-508-553-8850 ext 234; orEvan Smith, CFA, +1-212-850-5606, or Erica Pettit, +1-212-850-5614 both ofFinancial Dynamics
Web site: http://www.sontra.com/