Company Receives Comments From FDA That Are Consistent With Expectations
Plans National Exchange Listing and Anticipates Revenue in Third Quarter
FRANKLIN, Mass., Feb. 8, 2011 /PRNewswire/ -- Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE), a company developing the SymphonyTM tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the PreludeTM SkinPrep System for transdermal drug delivery, today announced that the Company's partner, Ferndale Pharma Group, LLC, received comments from the U.S. Food and Drug Administration (FDA) on the 510(k) submission of the Prelude SkinPrep System that were deemed minor and were consistent with both companies' expectations. Echo anticipates that the comments will be addressed quickly and that the planned commercial launch date for the product will remain on track, pending FDA clearance.
As a result of the feedback from the FDA, the Company is now accelerating the final Prelude manufacturing validation and scale-up in order to prepare for commercial launch. Management reiterated its expectation that 2011 will be a transformative year as Echo expects Prelude to receive market clearance and to generate revenues in the third quarter of 2011.
The Company also disclosed today that it has completed the $6.5 million of financing previously announced. Importantly, the Company believes that it now has sufficient funds to substantially complete the development of Symphony. As a result of this and other recent positive developments, Echo plans to apply for listing on a national exchange.
"With a strong balance sheet, much of the Symphony product development work complete, and two strategic partnerships in place, Echo is focused on completing several key milestones during 2011 that will enable the company to begin generating revenue," commented Patrick T. Mooney, M.D., Chairman and Chief Executive Officer of Echo Therapeutics. "Our primary focus is the successful completion of manufacturing and final product specifications in order to garner FDA clearance of Prelude. We believe that the FDA's comments will allow us to accelerate our manufacturing scale-up for product validation and product launch in 3Q2011. Additionally, we believe that FDA clearance of Prelude will clear the way for completing additional strategic partner licensing arrangements this year."
"Through hard work, we believe that we have set the stage for an exciting and productive 2011," Dr. Mooney continued. "We look forward to working with Ferndale to grow the topical anesthetic market in the US and generate cash flow for Echo in 2011. Additionally, we plan to have the final Symphony System, which includes Prelude, ready in 2Q11 and begin final testing at that time. We believe that we are positioned to be 'first-to-market' with tCGM in the hospital critical care market. We estimate that the hospital market opportunity for continuous glucose monitoring is greater than $1 billion. In addition, we plan to develop the Symphony System for use in the consumer market, providing additional upside potential and partnership possibilities in this more than $12 billion market opportunity."
About Echo Therapeutics
Echo Therapeutics is developing the Symphony tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system for patients with diabetes and for use in hospital critical care units. Echo is also developing its needle-free Prelude SkinPrep System as a platform technology for enhanced skin permeation for delivery of topical pharmaceuticals.
About Ferndale Pharma Group
The Ferndale Pharma Group of companies specializes in the development, manufacture, distribution and marketing of various dermatologic products including prescription topical drugs for the treatment of several acute and chronic dermatoses, medical devices that support and maintain wound closures and an extensive line of proprietary cosmeceutical products.