Echo Therapeutics has submitted 510(k) premarket notification to the US Food and Drug Administration (FDA) for its Prelude SkinPrep System and 4% lidocaine cream.

Echo Therapeutics is developing needle-free Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system and Prelude SkinPrep System for transdermal drug delivery.

Upon FDA clearance, Echo will receive a $750,000 milestone payment and a double digit royalty on product sales under an agreement signed with Ferndale in May 2009.

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 SkinPrep System 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.

Echo president, board chairman and CEO Patrick Mooney said that this is an important milestone in their initiative to create novel applications for the 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.

“Together with our partner, Ferndale Pharma Group, we look forward to receiving FDA clearance and the subsequent generation of royalty revenue from product sales,” Mooney said.

“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.”