The Company indicated no additional changes were required and that the current device would be identical to the one marketed after FDA approval.
The Prelude system will be tested using LMX4 lidocaine cream and success will result in a 510-k filing with Ferndale Pharma Group for augmented delivery of the substance, a market which ECTE projects to exceed $1 billion.
Chairman and CEO of ECTE, Patrick T. Mooney, M.D. spoke of the completion of development for Prelude saying “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.”
Doctor Mooney indicated ECTE was ready to complete clinical trials and enter product commercialization as the paradigm product for topical lidocaine delivery, and that this next generation model was a big improvement over earlier prototypes. Mooney anticipates the LMX4 testing will go well and demonstrate the local dermal anesthesia capabilities of the system, leading to 510-k market clearance from the FDA.
With plans to test the Prelude system in conjunction with the Symphony tCGM glucose biosensor in diabetics and patients requiring continuous glucose monitoring, the Company hopes to offer this additional, standalone, single-use, low-cost biosensor in related applications very soon.
Suitable for preparing a small area of skin for the non-invasive, continuous biosensing Symphony tCGM system, or for transdermal drug delivery, the Prelude incorporates ECTE’s proprietary skin permeation control feedback technology into a robust and easy-to-use wireless handheld unit.