Shares of Echo Therapeutics (ECTE) have ballooned in Tuesday morning trading after the biotech reported positive results from a trial for its less-invasive continuous glucose monitoring (CGM) system and plans to file for a CE Mark to commercialize the product in Europe.
The Philadelphia-based medical device maker is developing its needle-free Symphony CGM System for use initially in the hospital critical care setting. Symphony uses Prelude, Echo’s skin permeation device, a transdermal sensor, wireless transceiver and data display technologies to deliver real-time readings of blood sugar to detect and prevent hyperglycemia and hypoglycemia for critically ill patients or those with diabetes.
Current standards of care in CGM are needle-based, requiring patients to insert a glucose sensor through the skin to measure glucose of interstitial fluids.
The clinical trial evaluated the performance of Echo’s Symphony CGM System in 32 post-surgical critical care patients across four clinical sites. It was the largest trial to date for Symphony and the first time that components of the system were used together in a clinical trial. Blood samples were collected from the patients, which were analyzed and compared to glucose readings collected by the Symphony system. The trial met its primary endpoints of safety and effectiveness, with no adverse events reported and nearly perfect accuracy in detected blood glucose levels.
More than 630 Symphony CGM glucose readings were paired with reference blood glucose measurements. The Continuous Glucose-Error Grid Analysis (A) showed that 97.9% of the readings were clinically accurate and 1.8% were benign errors (B), with a combined A+B value of 99.7%.
"We believe Symphony demonstrated satisfactory safety, accuracy and reliability during the clinical trial to satisfy CE Mark requirements," said Robert F. Doman, Executive Chairman and Interim CEO of Echo Therapeutics, in a statement today. He added, "We believe that there is great clinical need in the hospital for a non-invasive continuous glucose monitoring system, like Symphony, to support glycemic control protocols in hospital critical care units, leading to improved clinical outcomes."
Most may see the potential use for the Symphony technology for the enormous diabetes population (which is certainly a viable application), but not all diabetes patients require continuous glucose monitoring. According to the Echo website, about 80 percent of all hospitals in the United States and Europe have protocols in place for glycemic control.
The company said that it intends to use the data from the trial to pursue a CE Mark, with expectations to have the application filed with European regulators by the end of the year.
Shares of ECTE started climbing on Monday when the company said that it would be releasing the results of the trial today, closing the day ahead about 15 percent at $2.69. With the data release, shares skyrocketed in pre-market trading and hit a high of $4.91 shortly after the opening bell before settling back about one hour into the trading session to $4.34 for gains in excess of 60 percent.
DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer