Echo Therapeutics (ECTE) is a company developing a non-invasive (needle-free), wireless, system for people with diabetes and for use in hospital critical care units.
ECTE's products include the transdermal continuous glucose monitoring (tCGM) system and the Prelude™ SkinPrep System for transdermal drug delivery. The Prelude™ SkinPrep System incorporates Echo's patented feedback mechanism for optimal, safe control of skin ablation and its non-invasive transdermal biosensor technologies. With Symphony, Echo is focused on providing reliable, on-demand glucose data continuously, conveniently and cost-effectively. Echo's goal is to change the current paradigm of invasive, episodic glucose testing for people with diabetes and for use in hospital critical care settings with a reliable, needle-free and easy-to-use tCGM system that can provide continuous tracking and trending of glucose levels throughout the day and night.
ECTE is leveraging it's AzoneTS™ skin ablation technology to develop a wide-variety of new transdermal reformulations of pharmaceutical products previously approved by the FDA. Echo has submitted a New Drug Application (NDA) to the FDA covering its lead AzoneTS-reformulated product candidate, Durhalieve™, for treatment of corticosteroid responsive dermatoses.
Echo is also focused on Phase 2 development of Durhalieve for keloid scarring.
What does all that mean in English? It means this: ECTE has a revolutionary, PATENTED, one-of-a-kind diabetes monitoring system that uses a proprietary needle-free platform technology! In short, if your child, friend, family member or anyone one of 171 million people with diabetes according to The World Health Organization, a figure that is likely to more than double by 2030 then they no longer require a needle every single day. ECTE's technology is quickly making inroads in the medical community as a viable alternative to needles and could easily become an acquisition target!
ECTE also believes that its Prelude SkinPrep System will allow many drugs currently delivered by needle injection to be administered without a needle by using Prelude prior to transdermal drug administration, this alone could add substantial value to ECTE.
ECTE Investor Highlights
Entered into a $15 million license agreement with Ferndale Pharma Group, Inc. which granted to Ferndale the right to develop, market and sell Echo's Prelude SkinPrep System for enhanced delivery of Ferndale's topical lidocaine product, LMX4, in North America and the United Kingdom. In exchange, Echo received: An initial licensing fee of $750,000 and an additional $750,000 fee upon FDA approval; $12.5 million in milestones and guaranteed minimum royalty payments; and Royalties on net sales of disposable Prelude components.
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 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 $1 billion.
Entered into a license agreement with Handok Pharmaceuticals Co., Ltd. which granted Handok a license to develop, market and sell Echo's Symphony tCGM System for needle-free continuous glucose monitoring in South Korea. In exchange, Echo received: A licensing fee of approximately $600,000 upon execution of the License Agreement; Milestone payments upon receipt of the US FDA's clearance of Symphony and upon the first commercial sale of Symphony in South Korea; Royalties on net sales of Symphony; and Additional milestone payments upon the achievement of other commercial targets.
In November, Echo announced positive results of a clinical study of its Symphony tCGM System in patients with Type 1 and Type 2 Diabetes. The purpose of the study was to test the performance of the new, improved one-piece, cost-effective and easy-to-use biosensor. To date, Echo has conducted six consecutive positive pilot studies demonstrating effective and safe monitoring of glucose levels using Echo's skin permeation platform technology.
To date, Echo's medical device patent portfolio consists of 7 U.S. patents and 4 foreign patents, as well as 8 U.S. patent applications and 37 foreign patent applications.
During 2009, Echo either converted or repaid approximately $2.4 million of secured and unsecured debt, improving its working capital position.
ECTE anticipates Achieving AMEX or Nasdaq listing and completing additional strategic partner licensing arrangements.
"The last year was one of significant accomplishment and progress against the backdrop of a very tough macroeconomic climate. Through much hard work, we believe that we have set the stage for an exciting and productive 2010," CEO Dr. Mooney stated. "Looking forward, royalties on Prelude disposables and lidocaine sales provide near-term revenue opportunity for Echo. Additionally, we are positioned to be 'first-to-market' with tCGM in the hospital critical care market and we estimate that the hospital market opportunity for continuous glucose monitoring is greater than $1 billion. In addition, we plan to develop the Symphony product for use in the consumer market, providing additional upside potential and partnership possibilities in this more than $10 billion market opportunity."
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