Echo, www.echotx.com – the developers of the revolutionary Symphony™ tCGM System for continuous glucose monitoring and Prelude™ SkinPrep System for transdermal drug delivery, reported submission of a 510(k) premarket notification to the FDA today for its Prelude System and 4% lidocaine cream (anticipated market clearance is 90 days).
Having developed the Symphony, a needle-free, non-invasive and wireless system, around the Prelude system, ECTE believes the technology offers unprecedented quality of life for diabetics, especially for patients in critical care or ambulatory environments.
President, Chairman and CEO of ECTE, Patrick T. Mooney, M.D., called this news a major milestone in the Company’s drive to create novel applications for its proprietary technology.
This announcement follows fast on the heels of a clinical study in August of this year, which analyzed the use of Prelude to prep the skin before applying the OTC 4% lidocaine cream as a fast-acting local dermal anesthesia.
Dr. Mooney explained that the use of Prelude to effectively enhance topical lidocaine use represents a huge near-term revenue stream for the Company. He also hailed partner Ferndale Pharma Group, Inc., showing clear excitement over the pending FDA clearance of the product and subsequent generation of royalties from sales.
Ferndale was granted a North America and UK license to use Prelude as a skin prep for topical analgesics, anaethetic cream or local dermal anesthesia prior to needle insertion or IV via a May 2009 agreement with ECTE.
The Company is slated to receive a $750k milestone payment, in addition to a double-digit royalty on product sales, once FDA clearance is granted.
It is clear that the Prelude System has a wide range of potential applications throughout the therapeutics market and ECTE is confident that today’s submission and the eventual approval of the system will lead to continued prosperity for the Company.
The Prelude System uses a patented skin permeating feedback control technology developed by ECTE, which, in conjunction with the wireless hand-held device, enables efficient permeation of the tough outer skin layer. The Prelude preps a small area of skin for the Symphony’s non-invasive biosensor/transceiver or for the transdermal application of various drugs.
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