Diabetic Neuropathy Study Using Anodyne Therapy Published in Diabetes Care Demonstrates Reversal of Symptoms

TAMPA, Fla.--(BUSINESS WIRE)--Jan. 19, 2004--Anodyne(R) Therapy today announced the publication of its second peer-reviewed clinical study to demonstrate restoration of sensation in the feet of diabetic patients with peripheral neuropathy. This landmark study, conducted at the Joslin Diabetes Center at Morton Plant Hospital in Clearwater, FL, appears in the January 2004 issue of Diabetes Care (the Professional Journal of the American Diabetes Association) and is entitled, "Restoration of Sensation, Reduced Pain, and Improved Balance in Subjects with Diabetic Peripheral Neuropathy; A Randomized, Double Blind, Placebo Controlled Study." The study showed that after twelve 45-minute treatments, there was a 46% improvement in sensation and pain decreased by 45%. Additionally, 70% of patients reported an improvement in balance and less fear of falling.

Neuropathy is nerve damage often associated with diabetes and other chronic diseases. Symptoms include numbness and/or pain in the feet, legs and hands. Neuropathy from some causes like diabetes is usually considered to be progressive and irreversible and is a major contributing factor to chronic foot wounds, over 60,000 amputations per year and falls. The cost of diabetic neuropathy alone to the U.S. healthcare system has been reported to exceed $37 billion per year.

"We are very excited about this new study, which further demonstrates the profound clinical improvements that can be attained using our photo-energy-based technology to reduce sensory impairments due to diabetic neuropathy," said Craig Turtzo, CEO. "Our Anodyne Therapy System is currently being used in more than a thousand clinical sites by physicians and therapists to assist them in improving functional outcomes for patients suffering from peripheral neuropathy, chronic pain and a broad range of other health problems. Because of the broad-based acceptance in the medical community, we now have clinical data on more than 1500 patients that demonstrate consistent improvements in functional limitations due to peripheral neuropathy."