Echo Therapeutics Announces Commercial Launch of Prelude™ on Track

Company Receives Comments From FDA That Are Consistent With Expectations

Plans National Exchange Listing and Anticipates Revenue in Third Quarter

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Feb 08, 2011, 08:30 ET

FRANKLIN, Mass., Feb. 8, 2011 /PRNewswire/ -- Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE), a company developing the Symphony™ tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and the Prelude™ 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.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo's and its partners' ongoing studies, including the efficacy of Echo's Symphony tCGM and Prelude SkinPrep Systems, the failure of future development and preliminary marketing efforts related to Echo's Symphony tCGM and Prelude SkinPrep Systems, Echo's ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo's and its partners' ability to develop, market and sell diagnostic and transdermal drug delivery products based on its skin permeation platform technologies, including the Symphony tCGM and Prelude SkinPrep Systems, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its Symphony tCGM and Prelude SkinPrep Systems. These and other risks and uncertainties are identified and described in more detail in Echo's filings with the Securities and Exchange Commission, including, without limitation, its annual report on Form 10-K for the year ended December 31, 2009, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.