, Aug. 1, 2012
/PRNewswire/ -- Echo Therapeutics, Inc. (Nasdaq: ECTE), a company developing its needle-free Symphony® tCGM System as a non-invasive, wireless, transdermal continuous glucose monitoring system and its Prelude® SkinPrep System for transdermal drug delivery, today announced positive results from its clinical trial of the Symphony tCGM System in major general surgery and cardiothoracic surgery patients. This study is the second of two studies in critically ill patients.
Data from this study demonstrate that Symphony successfully and continuously monitored glucose levels in the intensive care unit at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania. Data analysis demonstrated that Symphony 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%
"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," said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "We believe, if used effectively, Symphony will help prevent hypo- and hyperglycemic excursions in patients and will improve patient outcomes."
Jeffrey I. Joseph, D.O., Professor of Anesthesiology and Director of the Jefferson Artificial Pancreas Center at Thomas Jefferson University, and the Principal Investigator of the study, added: "The Echo Therapeutics' continuous glucose monitoring system safely and accurately measured the concentration of glucose in a wide variety of surgical patients managed in the ICU. Study physicians and nurses found the non-invasive, wireless continuous glucose monitoring system easy to apply and utilize in the critical care environment. Current methods of glucose monitoring in the hospital are intermittent, labor intensive, prone to error, and expose the caregiver to blood. Hospitals rarely monitor glucose frequently enough to minimize hyperglycemia and avoid hypoglycemia. Thus, there is great clinical need in the hospital for a continuous glucose monitoring system that reliably provides a real-time glucose measurement every minute or two. The bedside clinician will use the glucose trend information to support glycemic control protocols, leading to improved clinical outcome. The Echo Therapeutics' Symphony continuous glucose monitoring system demonstrated satisfactory safety, accuracy, and reliability during the clinical trial at Thomas Jefferson University Hospital."
Using over 1,200 Symphony tCGM glucose readings from fifteen (15) study subjects paired with reference blood glucose measurements, CG-EGA showed that 98.9% of the readings were clinically accurate and 0.3% were benign errors with a combined A+B of 99.2%. The MARD for the study was 9.0%. There were no adverse events reported from the Prelude skin preparation or the Symphony tCGM biosensor. The range of glucose values was 74 272 mg/dL.
This study was the second of two studies designed to evaluate the performance of Echo's Symphony tCGM System in the critical care setting. The study was performed at Thomas Jefferson University Hospital and enrolled fifteen (15) adult patients. The skin of each patient was prepared using Prelude and a Symphony tCGM biosensor was applied to the skin site after transfer to critical care. Reference blood samples were taken from arterial line catheters at 30-minute intervals and measured on a YSI 2300 STAT Plus Glucose Analyzer. The data collected by Symphony was blinded to study subjects and Jefferson clinical staff. At the conclusion of the study period, the test sites were inspected for redness or other undesirable effects.
Continuous data from the Symphony tCGM System were compared to reference measurements from the YSI 2300 STAT Plus Glucose Analyzer. Those reference measurements were paired with the Symphony results through a data analysis algorithm. The primary statistical analytical tools used to evaluate the performance of Symphony were the Continuous Glucose-Error Grid analysis (CG-EGA) and Mean Absolute Relative Difference (MARD). The CG-EGA is a categorization of all data pairs based on the clinical significance of the accuracy. Accurate readings result in the same clinical decision when based on the CGM value versus the blood glucose value. Benign errors lead to the same clinical outcome as accurate readings even though the actual clinical decision may differ. Erroneous readings lead to clinical errors. CGM performance is measured as the sum of accurate readings and benign errors. Numerical accuracy is measured using MARD, an error calculation tool that was used to measure the absolute value of the average relative difference between Symphony and the reference measurements, on a percentage basis.
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.
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 safety and 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, 2011, 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.
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Christine H. Olimpio
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SOURCE Echo Therapeutics, Inc.