Echo Therapeutics (Echo), a company developing the needle-free Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system has completed the product development work for its Prelude SkinPrep System and has the commercially ready product to be used in final clinical trials.
The company 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 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 Group for the enhanced delivery of lidocaine. The company believes that the addressable market for enhanced, fast acting topical lidocaine exceeds $1bn.
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 company’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 Therapeutics, 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 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.”