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.
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