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Echo Completes Product Development For Prelude SkinPrep System

Echo Therapeutics (Echo) has completed the product development work for its Prelude SkinPrep System and now has the product ready to be used in final clinical trials. Echo anticipates that no further changes will be made to the Prelude SkinPrep System and that the current device will be the one used for sale, subject to FDA market clearance of the product.

The company said that the final Prelude device replaces the prototype device used in earlier clinical trials and will be tested in the near-term in a study using LMX4 lidocaine cream which should form the basis for a 510-k filing with Ferndale Pharma for the enhanced delivery of Lidocaine.

The company also anticipates that the completed Prelude will be tested in the near future with its recently completed one-piece, cost-effective, single-use Symphony tCGM glucose biosensor in patients with diabetes and critically ill patients who require aggressive glucose monitoring.

Prelude incorporates Echo’s patented skin permeation control feedback technology into a comfortable, wireless, hand-held device used to prepare a small area of the skin for the non-invasive, biosensor and monitoring components of its Symphony tCGM system or for transdermal drug delivery.

Patrick Mooney, chairman and CEO of Echo, said: “The completion of the product development work on our Prelude SkinPrep System, our skin preparation platform technology used for both transdermal drug delivery and skin preparation prior to the application of the Symphony tCGM glucose biosensor represents one of the most important milestone events in the company’s history.

“We are now prepared to complete our clinical validation and begin commercialization efforts in enhanced topical lidocaine delivery. This next generation skin preparation device incorporates substantial improvements beyond the prototype used in earlier studies. We anticipate testing Prelude with LMX4 anesthetic cream for enhanced local dermal anesthesia in the near-term and subsequently seeking 510-k market clearance from the FDA.”