Healthcare Industry News: Transdermal
News Release - July 25, 2006
Sontra Announces Preliminary Results from a 24 hour Clinical Evaluation of its Continuous Transdermal Glucose MonitorSontra's Glucose Flux Sensor is the first Transdermal system validated for 24 hours
FRANKLIN, Mass., July 25 (HSMN NewsFeed) -- 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® 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.
Source: Sontra Medical
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