A needle-free, transdermal glucose monitoring device for critical care patients has generated positive results in the second of two clinical trials.
The study for Echo Therapeutics‘ (NASDAQ:ECTE) Symphony system was performed at Thomas Jefferson University Hospital. It enrolled 15 adult patients in critical care settings undergoing major general surgery and cardiothoracic surgery. Reference blood samples were taken from arterial line catheters at 30-minute intervals and measured on a YSI 2300 STAT Plus Glucose Analyzer. Altogether, 1,200 Symphony tCGM glucose readings were taken. The device’s error rate was 9 percent and a Continuous Glucose-Error Grid analysis showed that 98.9 percent of the readings were clinically accurate, according to the statement.
The next step for the Philadelphia company will be to meet with the European regulatory authorities and the U.S. Food and Drug Administration. It plans to seek CE Mark approval in Europe before completing a pivotal trial and filing for FDA approval.
Although several glucose monitors have been on the market or are coming to market, Echo Therapeutics is keen to carve a niche for itself in the critical care area. But its CEO Patric Mooney also envisions the device as having potential for transdermal drug delivery, a market he valued at $5.6 billion.
Jeffrey I. Joseph, a professor of anesthesiology and the director of Thomas Jefferson University’s Artificial Pancreas Center, served as the principal investigator for the study. He noted that current practices for glucose monitoring in the hospital are intermittent, labor intensive, prone to error and expose caregivers to blood.
“Hospitals rarely monitor glucose frequently enough to minimize hyperglycemia and avoid hypoglycemia,” he said in a statement.
Last month, the company signed an amended licensing agreement with Ferndale Pharma Group for the use of Echo’s Prelude skin prep system with its local anesthetic lidocaine cream that it plans to begin marketing next year. Under the amended deal, Echo receives milestone payments upon Ferndale’s receipt of regulatory clearance in South America, Australia, New Zealand, Switzerland and portions of the European community. Ferndale also will pay milestone payments based on the achievement of certain net sales targets in certain countries, in addition to paying royalties from its sales of Prelude together with its lidocaine cream.
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