Echo Therapeutics, Inc. (Nasdaq: ECTE) today announced positive results from its clinical trial of the Symphony® tCGM System in major general surgery and cardiothoracic surgery for critically ill patients
Continuously monitored glucose levels with Symphony® tCGM in the intensive care unit at Thomas Jefferson University Hospital in Philadelphia, ECTE’s Symphony System accurately read glucose levels with a mean absolute relative difference (MARD), or error rate of 9.0%. The Continuous Glucose-Error Grid analysis (CG-EGA) showed that 98.9% of the readings were clinically accurate (A) and 0.3% were benign (B) errors with a combined A+B of 99.2%
Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics, noted:
We are extremely pleased with the positive results of this trial which demonstrate that Symphony can accurately read glucose in critically ill patients who have undergone major general surgery. Additionally, this study demonstrates that Symphony performs consistently well in yet another patient group. Data from this study are very similar to patients in other studies with differing disease states. We believe, if used effectively, Symphony will help prevent hypo- and hyperglycemic excursions in patients and will improve patient outcomes.
Prelude SkinPrep System
A 510(k) equivalency study was completed to determine the efficacy of Prelude in enhancing the onset of the effectiveness of 4% lidocaine cream.
A 510(k) premarket notification has been submitted to the US Food and Drug Administration (FDA) for the Prelude SkinPrep System for the delivery of 4% lidocaine cream.
Symphony tCGM System
Our Symphony tCGM System is currently in development with an advanced prototype of the Symphony tCGM biosensor. Symphony has successfully completed numerous clinical trials with Symphony and plans additional studies of Symphony in the near future.
Echo has granted the Ferndale Pharma Group, Inc. and its wholly owned subsidiary Eloquest Healthcare Inc. a license to develop, market and sell the Prelude device for enhanced, fast-acting and needle-free delivery of Ferndale’s topical 4% lidocaine product in North America and the U.K.
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.
Echo has granted Handok Pharmaceuticals a license to develop, market and sell the Symphony® tCGM System to continuously monitor glucose levels in diabetics and hospital patients in South Korea.
Handok is the leader in diabetes treatment in Korea. Handok, founded in 1954, is the pharmaceutical company in Korea with the most successful track record of various types of partnerships, focusing on innovative products. It formed a JV with Hoechst in 1965, which lead to the current strategic partnership with Sanofi-Aventis. Handok maintains a world class GMP facility and was the first local Korean company to incorporate clinical research capabilities with medical directors on staff.
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Echo Therapeutics is a transdermal medical device company with deep expertise in advanced skin permeation technology. Echo is developing its Prelude® SkinPrep System as a platform technology to allow for significantly enhanced and painless skin permeation.