Echo Therapeutics and Ferndale Pharma Initiate Clinical Trial for Prelude(TM) SkinPrep Device and 4% Lidocaine Cream
4/27/2010 8:21:14 AM
FRANKLIN, Mass., April 27 /PRNewswire-FirstCall/ -- Echo Therapeutics, Inc., a company developing its needle-free Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and its Prelude™ SkinPrep System for transdermal drug delivery, in collaboration with its strategic partner, Ferndale Pharma Group, Inc., announced today that the first patients were enrolled in a clinical study of its Prelude SkinPrep System. This clinical study is designed to evaluate the ability of the Prelude SkinPrep System to ablate the skin prior to application of OTC 4% lidocaine cream for local dermal anesthesia. Upon completion of this study, Ferndale and Echo anticipate submitting a 510(k) premarket notification to the United States Food and Drug Administration (FDA) with subsequent commercial launch of the product after 510(k) clearance.
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