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Echo Therapeutics Provides Business Update
Date:12/29/2009

FRANKLIN, Mass., Dec. 29 /PRNewswire-FirstCall/ -- Echo Therapeutics, Inc. (OTC Bulletin Board: ECTE), a company developing its needle-free Symphony(TM) tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system and its Prelude(TM) SkinPrep System for transdermal drug delivery, today provided a business update, and management reiterated its expectation that 2010 will be a transformative year as Echo completes the development and regulatory review of its lead products and anticipates generating initial revenues.

2009 Business Review

Licensing

  • Echo 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.

Ferndale will pay all product development and regulatory fees and expenses necessary to obtain product approval in North American and the United Kingdom.

  • Echo also 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.

Handok will pay all product development and regulatory expenses related to Symphony's approval in South Korea.

Operational

  • 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.
  • During the second quarter of 2009, Echo entered into an Exchange Agreement with holders of the Company's Series A Convertible Preferred Stock for approximately 2.3 million shares of Common Stock at an exchange price of $.75 per share.
  • In the fourth quarter of 2009, Echo completed private placements of common stock and warrants to purchase common stock for approximately $4.0 million through the sale of approximately 2.3 million shares of common stock at $1.25 per share.

2010 Milestones

"With a strengthened and simplified balance sheet, much of the initial product development work complete, and two strong strategic partnerships in place, Echo is focused on completing several key milestones during 2010 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 a critical care study with a commercially ready Symphony system, which we believe will be the basis for us to receive FDA approval for Symphony. In addition, we anticipate the completion of a clinical trial by Ferndale using the Prelude SkinPrep system for a reduced time and enhanced delivery of lidocaine. This will result in a near-term filing of a 510k application with the FDA. These events will enable us to begin manufacturing scale-up for product validation and planned product launch in 2010."

In addition, Echo anticipates:

  • Building an internal management team for product launch;
  • 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," Dr. Mooney continued. "Looking forward, royalties on Prelude disposables and lidocaine sales provide near-term revenue opportunity for Echo. We look forward to working with Ferndale to grow the topical anesthetic market in the US and UK and generating cash flow for Echo in 2010. 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."

About Echo Therapeutics

Echo 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 transdermal drug delivery of a wide range of novel topical reformulations of widely-used, FDA-approved 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 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 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, 2008, 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.



    10 Forge Parkway
    Franklin, MA 02038, USA
    Tel: 1+ 877-476-6872
    Fax: 1+ 508-553-8760
    www.echotx.com


SOURCE Echo Therapeutics, Inc.


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SOURCE Echo Therapeutics, Inc.
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