Echo Therapeutics Waiting to Hear Back from FDA

On November 11th of this year, Echo Therapeutics Inc™, a transdermal medical device company based out of Franklin, Massachussetts, submitted their revolutionary Prelude SkinPrep System™ and 4% lidocaine cream to the FDA for 510(k) clearance. Market clearance is expected to take ninety (90) days.

Earlier this August, Echo Therapeutics announced the successful completion of a clinical trial for its Prelude SkinPrep System and 4% lidocaine cream. The Prelude SkinPrep System is a transdermal skin permeation device, designed for use in tandem with the Symphony tCGM System™, that measures the real-time electrical conductivity of the test skin site. The Prelude SkinPrep System will turn off automatically when the conductivity measurement reaches the appropriate level, as identified by the device’s algorithm, which creates individualized, optimal skin permeation. Thankfully for the user, the system removes only the outermost layer of the skin, known as the stratum corneum, which consists of the tough outer layer of dry, dead skin cells. This study evaluated the effectiveness of Prelude to thin the skin prior to the application of its OTC 4% lidocaine cream in order to create local dermal anesthesia more quickly than other methods.

The Symphony tCGM System™ is a non-invasive (needle-free), wireless, transdermal continuous glucose monitoring system which will provide accurate, real-time blood glucose data conveniently, continuously, and affordably in an ambulatory environment or a critical care setting. Echo Therapeutics is hoping to allow for better overall clinical outcomes for patients in hospital critical care units and for people with diabetes. Up until now, all FDA-approved continuous glucose monitoring systems have been needle-based, which naturally involves a risk of infection, inflammation, or bleeding from the insertion site. In addition to eliminating these risks, the Symphony tCGM System would remove the element of discomfort.

After an initial skin permeation with Prelude, a biosensor is placed on the permeated site, and after a brief warm up period for the biosensor, Symphony can wirelessly provide the patient’s glucose level every minute to a remote glucose monitor, which then tracks the levels and changes in glucose and provides visual and audible alarms in the event of a patient’s levels moving outside of the personalized target range. In this way, Symphony will provide real-time access to glucose values and should identify prolonged patient excursions into the hyperglycemic and hypoglycemic zones.

In May 2009, Echo Therapeutics entered into a license agreement with Ferndale Laboratories™ in which it granted Ferndale a license in North America and the United Kingdom to develop, assemble, use, market, sell and export Prelude for skin preparation prior to the application of a topical analgesic or anesthetic cream. Upon FDA clearance, Echo will be receiving a $750,000 milestone payment as well as a double digit royalty on product sales from Ferndale.

On November 29th of this year, Echo was featured in Diabetes Health Magazine with a full article advocating the use of the Symphony tCGM System, which has a total circulation of 150,000 readers, including a 100,000-member “controlled and qualified Direct-to-Patient Circulation Program,” which is requested by and distributed to a controlled and qualified list of certified diabetes educators, physicians, and nurses. These professionals then give Diabetes Health to 100,000 newly diagnosed patients as an educational tool every two months.

“This is an important milestone in our initiative to create novel applications for our proprietary technology and follows the successful completion, in August 2010, of a clinical study that was designed to evaluate the effectiveness of Prelude to ablate the skin prior to the application of OTC 4% lidocaine cream for faster-acting local dermal anesthesia,” stated Patrick T. Mooney, M.D., CEO, President and Chairman of the Board of Echo Therapeutics. “The use of Prelude to enhance the onset of topical lidocaine represents a near-term revenue opportunity for Echo Therapeutics. Together with our partner, Ferndale Pharma Group, Inc., we look forward to receiving FDA clearance and the subsequent generation of royalty revenue from product sales… We look forward to market clearance by the FDA and the ultimate launch of this product so that, in partnership with Ferndale, we may take a first step toward bettering the lives of patients who can benefit from this technology.”

Echo Therapeutics, Inc, will be presenting at the OneMedForum SF, held in San Francisco from January 11-13th 2011.

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