FRANKLIN, Mass., Jan 11 /PRNewswire-FirstCall/ -- Echo Therapeutics, Inc. (OTC Bulletin Board : ECTE), a company developing the needle-free Symphony(TM) tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude(TM) SkinPrep System for transdermal drug delivery, announced today that the Company has completed the product development work for its Prelude SkinPrep System and now has the commercially ready product to be used in final clinical trials.
Echo anticipates that no further changes will be made to the Prelude SkinPrep System and that the current device will be the one used for sale, subject to FDA market clearance of the product. The final Prelude device replaces the prototype device used in earlier clinical trials and will be tested in the near-term in a study using LMX4 lidocaine cream which should form the basis for a 510-k filing with Ferndale Pharma Group for the enhanced delivery of lidocaine. The Company believes that the addressable market for enhanced, fast acting topical lidocaine exceeds $1 billion.
"The completion of the product development work on our Prelude SkinPrep System, our skin preparation platform technology used for both transdermal drug delivery and skin preparation prior to the application of the Symphony tCGM glucose biosensor represents one of the most important milestone events in the Company's history," stated Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "We are now prepared to complete our clinical validation and begin commercialization efforts in enhanced topical lidocaine delivery. This next generation skin preparation device incorporates substantial improvements beyond the prototype used in earlier studies. We anticipate testing Prelude with LMX4 anesthetic cream for enhanced local dermal anesthesia in the near-term and subsequently seeking 510-k market clearance from the FDA."
The Company also anticipates that the completed Prelude will be tested in the near future with its recently completed one-piece, cost-effective, single-use Symphony tCGM glucose biosensor in patients with diabetes and critically ill patients who require aggressive glucose monitoring. Prelude incorporates Echo's patented skin permeation control feedback technology into a comfortable, wireless, hand-held device used to prepare a small area of the skin for the non-invasive, biosensor and monitoring components of its Symphony tCGM system or for transdermal drug delivery.
About Echo Therapeutics
Echo is developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system for patients with diabetes and for use in hospital critical care units. Echo is also developing its needle-free Prelude SkinPrep System for transdermal drug delivery of a wide range of novel topical reformulations of widely-used, FDA-approved products.
Cautionary Statement Regarding Forward Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo's and its partners' ongoing studies, including the efficacy of the Symphony tCGM System and Prelude SkinPrep System, the failure of future development and preliminary marketing efforts related to the Symphony tCGM System and Prelude SkinPrep System, Echo's ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo's ability to develop, market and sell diagnostic and transdermal drug delivery products based on its skin permeation platform technologies, including the Symphony tCGM System and 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, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to the Symphony tCGM System and the Prelude SkinPrep System. These and other risks and uncertainties 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-K for the year ended December 31, 2008, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. Echo Therapeutics, Inc. undertakes no obligation to publicly update or revise any forward-looking statements.
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SOURCE Echo Therapeutics, Inc.