Echo Therapeutics, Inc. (ECTE), just announced positive results from its clinical study of its Symphony tCGM System; its lead program in analyte monitoring- a non-invasive, wireless, transdermal continuous glucose monitoring (tCGM) system.
Days ago in a special report, we told our readers that investors were anticipating news about this clinical trial and data from the study confirm that Symphony successfully monitors patient glucose levels and continues to demonstrate improvements in clinical performance. Echo plans to conduct a study in patients with diabetes during the fourth quarter, followed by a study in critical care patients shortly thereafter.
"The results of this study demonstrate that this next generation of Symphony successfully monitors glucose levels and has the potential to be an important tool for tracking and trending of glucose. The adoption of CGM is growing rapidly in diabetes management, as is frequent glucose testing in critical care patients, as medical literature continues to underscore the need for better glucose control to improve patient outcomes," said Patrick T. Mooney, M.D., Chairman and CEO of Echo Therapeutics. "We are excited about these results and the potential for Symphony and we expect similar, positive results from the two additional studies in diabetics and critical care patients in the coming months."
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.
Until Echo’s glucose-monitoring device gets final Food and Drug Administration clearance for use with diabetics, which is expected in 2013, the state-of-the art are pocket-sized monitoring devices that draw blood with a needle to produce a blood sample to be analyzed. Based on reading the glucose levels on the blood sample, doctors determine each diabetic’s diet, exercise and insulin therapy regimen. Currently, the readings are taken several times daily. Finger pricks hurt. In contrast, Echo’s Symphony tCGM System, is the only device that monitors by biosensor — without pricking the skin — and provides readings continuously to catch sudden spikes or drops in glucose levels, which might otherwise go undetected.
Echo CEO Dr. Patrick Mooney told BioMedReports back in June: “The bottom line is all the glucose monitoring devices on the market are somewhat invasive involving lancing a patient’s fingertips to draw blood or wearing a continuous glucose monitor that has an invasive wire sensor. Nevertheless they are used by millions and have sales in the billions of dollars.”
Echo’s Symphony tCGM was developed based on another technology, originally conceived at Massachusetts Institute of Technology by Dr. Robert Langer, a foremost expert on transdermal technology. However, Langer’s focus was on a system for administering drugs. In contrast, Echo’s Symphony tCGM is essentially proving that a process based on his original concept can safely be reversed to read blood glucose levels. (Dr. Langer is the chairman of Echo’s Scientific Advisory Board.)
The Symphony System has been tested in several pilot studies in which the device has consistently demonstrated its high level of accuracy. The clinical studies demonstrate the device is appropriate for use both at home and in the hospital critical care units for patients with diabetes. This should position the device to receive FDA approval in 2013.
The Symphony technology has other important advantages over the current technology, in addition to the elimination of the painful needle pricks:
- It is continuous, giving readings 24/7, not just when the skin is pricked.
- Each sensor can be used for one day (possibly 2-3 days in the future) before being replaced by a fresh one (an attractive source of recurring revenue); and
- The needleless technology reduces the risk of infection, particularly in hospitals where contamination risk currently is critical.
Reducing the risk of infection is important because as CEO Mooney notes all existing FDA-approved continuous glucose monitoring systems use sensor wires inserted into the patient’s skin, increasing the risks of infection, inflammation or bleeding at the insertion point.
Echo’s Symphony System’s arrival could not be timelier. Some 8.3% of Americans — 25.8 million adults and children — are diabetics. And almost two million more Americans are diagnosed with diabetes every year. Moreover, diabetes complications — heart disease, strokes, lower limb amputations, high blood pressure, blindness, glaucoma, nerve damage, to name a few — cause more than 250,000 deaths every year. The loss in medical and associated costs is $218 billion.
Echo's platform for needle-free drug delivery and a wireless biosensor is a game changer that gives Echo a shot at the $10 billion market of diabetes monitoring. In addition, the Symphony platform has enormous potential for use in other markets, such as continuous monitoring of other important blood attributes, particularly in hospital critical care units.
We'll keep you posted.