Echo Therapeutics Announces Filing of 510(k) Submission Seeking Market Clearance from FDA for its Prelude SkinPrep System and 4% Lidocaine Cream
FRANKLIN, Mass., Nov. 11, 2010 /PRNewswire/ -- 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 that a 510(k) premarket notification has been submitted to the US Food and Drug Administration (FDA) for its Prelude SkinPrep System and 4% lidocaine cream. Market clearance is expected to take ninety (90) days.
"This is an important milestone in our initiative to create novel applications for our proprietary technology and follows the successful completion, in August 2010, of a clinical study that was designed to evaluate the effectiveness of Prelude to ablate the skin prior to the application of OTC 4% lidocaine cream for faster-acting local dermal anesthesia," stated Patrick T. Mooney, M.D., CEO, President and Chairman of the Board of Echo Therapeutics. "The use of Prelude to enhance the onset of topical lidocaine represents a near-term revenue opportunity for Echo Therapeutics. Together with our partner, Ferndale Pharma Group, Inc., we look forward to receiving FDA clearance and the subsequent generation of royalty revenue from product sales."
In May 2009, the Company entered into a license agreement with Ferndale pursuant to which it granted Ferndale a license in North America and the United Kingdom to develop, assemble, use, market, sell and export Prelude for skin preparation prior to the application of a topical analgesic or anesthetic cream for local dermal anesthesia or analgesia prior to a needle insertion or IV procedure. Upon FDA clearance, Echo will receive a $750,000 milestone payment and a double digit royalty on product sales from Ferndale.
In August 2010, the Company announced the successful completion of a clinical trial for its Prelude SkinPrep System and 4% lidocaine cream. A study evaluated the effectiveness of Prelude to ablate the skin prior to the application of OTC 4% lidocaine cream for faster-acting local dermal anesthesia. Echo believes that its Prelude SkinPrep System will have a wide range of therapeutic applications.
The Company believes that its needle-free Symphony™ tCGM System, which includes the Prelude™ SkinPrep System, can allow effective, needle-free glucose monitoring resulting in better patient outcomes in a critical care setting and for Diabetic patients in an ambulatory environment. Prelude incorporates a patented skin permeation control feedback technology with a wireless, hand-held device that facilitates efficient and effective permeation of the tough outer layer of the skin. Prelude prepares a small area of the skin for Symphony's non-invasive biosensor and transceiver or for transdermal drug delivery applications.
Dr. Mooney concluded, "We look forward to market clearance by the FDA and the ultimate launch of this product so that, in partnership with Ferndale, we may take a first step toward bettering the lives of patients who can benefit from this technology."
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.
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.