FRANKLIN, Mass., Aug. 24 /PRNewswire-FirstCall/ -- Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE), a company developing its needle-free Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system and its Prelude™ SkinPrep System for transdermal drug delivery, today announced the completion of a clinical study of Prelude. This clinical study was designed to evaluate the ability of Prelude to ablate the skin prior to the application of OTC 4% lidocaine cream for faster-acting local dermal anesthesia. As a result of the clinical trial, Echo now expects the submission of a 510(k) premarket notification to the United States Food and Drug Administration (FDA) in the near future.
The blinded comparison study evaluated the performance of Prelude prior to the application of 4% lidocaine cream for local analgesia and demonstrated remarkable improvement and an abbreviated onset of action.
"We are very pleased with the results of this clinical trial, and we look forward to the upcoming submission of the 510(k) to the FDA for purposes of achieving market clearance, clearing the path for the launch of this product," commented Patrick T. Mooney, M.D., CEO, President and Chairman of the Board of Echo Therapeutics, Inc. "In addition, regulatory clearance would result in a $750,000 milestone payment from our partner, Ferndale Pharma Group, Inc., as well the initiation of royalty revenues from the sale of the product. The use of Prelude to enhance the action of topical lidocaine represents the best near-term revenue opportunity for Echo Therapeutics and we are excited to have achieved these exceptional results today."
In May 2009, Echo granted Ferndale a license to develop, market and sell Prelude for delivery of topical 4% lidocaine product in North America and the United Kingdom.
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 as a platform technology for enhanced skin permeation for delivery of topical pharmaceuticals.
About Ferndale Pharma Group
The Ferndale Pharma Group of companies specializes in the development, manufacture, distribution and marketing of various dermatologic products including prescription topical drugs for the treatment of several acute and chronic dermatoses, medical devices that support and maintain wound closures and an extensive line of proprietary cosmeceutical 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 Echo's Symphony tCGM and Prelude SkinPrep Systems, the failure of future development and preliminary marketing efforts related to Echo's Symphony tCGM and Prelude SkinPrep Systems, Echo's ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo's and its partners' ability to develop, market and sell diagnostic and transdermal drug delivery products based on its skin permeation platform technologies, including the Symphony tCGM and Prelude SkinPrep Systems, 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 its Symphony tCGM and Prelude SkinPrep Systems. 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, 2009, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.
For More Information:
Patrick T. Mooney, M.D.
Media: Richard Stern
Chairman and Chief Executive Officer
Partner, Hayden IR
Stern & Co.
SOURCE Echo Therapeutics, Inc.