Echo Therapeutics out of Franklin, Mass has completed a clinical trial of its Prelude SkinPrep System and is planning to ask for approval from the FDA, according to the statement released by the company. The device is meant to permeate the skin in preparation for transdermal protein (or large molecule) drug delivery or maybe for taking prick-free blood glucose readings sometime in the future.
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.”
Press release: Echo Therapeutics Announces Successful Completion of Clinical Trial for Prelude™ SkinPrep System and 4% Lidocaine Cream…
Product page: Prelude SkinPrep System…
Flashbacks: Positive Results for Echo Therapeutics’ Noninvasive Glucometer; Symphony Transdermal Continuous Glucose Monitoring System Going to Clinical Trials
(hat tip: MassDevice)