Healthcare Industry News: Transdermal
News Release - July 1, 2008
Echo Therapeutics Initiates Clinical Study of Its Symphony(TM) Transdermal Continuous Glucose Monitoring System in Patients with Type 1 and Type 2 DiabetesFRANKLIN, Mass., July 1 (HSMN NewsFeed) -- Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE ) announced today that it has initiated a clinical study of its Symphony(TM) Transdermal Continuous Glucose Monitoring System (tCGM System) in patients with Type 1 and Type 2 diabetes. The Company expects to complete and announce the results of the study in the third quarter of 2008. Echo's non-invasive Symphony tCGM System consists of its Prelude(TM) SkinPrep System, which incorporates patented and leading-edge skin permeation control technology, and wireless transmission and proprietary Transdermal biosensor technologies. Echo's Symphony tCGM System is designed to provide both diabetes and hospital patients with a reliable, needle-free, easy-to-use, affordable and comfortable-to-wear continuous glucose monitoring device.
"Building on the momentum generated from our prior four positive pilot clinical studies, we are excited to have started our next pilot study in the important diabetes home use market. Our new Prelude Skin Prep System is a competitively unique component of our Symphony tCGM System, enabling our system to generate painless, needle-free, continuous glucose measurements. The primary purpose of this new study is to evaluate the performance of our Symphony tCGM System with Prelude as the new skin permeation element," stated Patrick T. Mooney, M.D., Echo's Chairman and Chief Executive Officer. "We are very excited about our significant development progress thus far, and we look forward to making additional progress with Symphony throughout 2008."
Echo's pilot clinical study will enroll ten (10) patients with diabetes (either Type 1 or Type 2) and will compare data obtained from its Symphony tCGM System with both the "gold standard" YSI Glucose Analyzer and a widely-used, commercially available "finger-stick" glucometer. The study will collect more than 900 data pairs to be used in the analyses. Reference glucose measurements will be made at 15 minute intervals for 24 hours with the study data blinded to study subjects and study personnel.
About Echo Therapeutics
Echo Therapeutics is focused on medical devices and specialty pharmaceuticals. Echo is developing a non-invasive, wireless, Transdermal continuous glucose monitoring (tCGM) system for patients with diabetes and for use in hospital critical care units, together with a wide range of novel topical reformulations of widely-used, FDA-approved products.
Cautionary Statement Regarding Forward Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward- looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks related to regulatory approvals and the success of Echo's ongoing studies regarding the efficacy of Echo's Symphony tCGM System, the failure of future development and preliminary marketing efforts related to Echo's tCGM systems, risks and uncertainties relating to Echo's ability to develop, market and sell diagnostic products based on its skin permeation platform technologies, including the Prelude SkinPrep System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, and regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its tCGM systems. Furthermore, Echo's tCGM system has not yet been approved for sale. The regulatory approval process for its tCGM system involves, among other factors, successfully completing pilot and pivotal clinical trials and obtaining a premarket approval, or PMA, from the FDA. The PMA process requires Echo to prove the safety and efficacy of its tCGM system to the FDA's satisfaction. This process can be expensive and uncertain, and there is no guarantee that Echo will be able to submit a PMA for its Symphony tCGM System or that its Symphony tCGM System will be approved by the FDA in any specific timeframe or at all. In addition, clinical testing of Echo's products and eventual commercialization of its products are subject to all of the risks and uncertainties set forth in its periodic reports filed with the Securities and Exchange Commission.
These and other factors are identified and described in more detail in Echo's filings with the Securities and Exchange Commission, including, without limitation, its annual report on Form 10-KSB for the year ended December 31, 2007, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. The foregoing list of factors is not exhaustive. Echo Therapeutics, Inc. undertakes no obligation to publicly update or revise any forward-looking statements.
Source: Echo Therapeutics
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