Anodyne Therapy (Tampa, Florida) has both an unusual name – "anodyne" meaning "relieving or lessening pain," according to Webster's – and a unique product offering. The company's Anodyne Therapy device uses photo energy to increase circulation and reduce pain.
The company also says that its Anodyne device offers the only treatment option for patients with peripheral neuropathy. A condition particularly affecting diabetics, this loss of protective sensation in the feet can cause chronic pain and ulcers, and may lead to amputation.
Until the FDA-cleared Anodyne Therapy was first used in this application in 2002, diabetic peripheral neuropathy was thought to be progressive and irreversible, with no effective treatments for improving foot sensation.
The company has been busy conducting research to support the clinical effect of its non-invasive Anodyne Therapy on this condition, which has estimated medical costs totaling $37 billion a year in those with diabetes.
Anodyne President and CEO Craig Turtzo told Medical Device Daily, "One of the reasons why we've been successful is that we've been very committed to evidence-based medicine, in the sense that we have so many clinical studies that support exactly what we say." He added: "Certainly, the more people who use [Anodyne Therapy] and the more studies that are published increase the exposure and the credibility of the technology."
The company recently reported publication of its sixth-peer reviewed study in the March/April 2005 Journal of the American Podiatric Medical Association, which demonstrated restoration of sensation in the feet of patients with peripheral neuropathy using Anodyne Therapy.
The prospective, open label, multi-center trial of 1,047 patients with peripheral neuropathy (including 790 diabetics) measured improvements in patients' ability to feel a standardized 10 gram Semmes-Weinstein Monofilament (SWM) test, deemed by Medicare to be the best measure of risk for diabetic ulcers and amputations.
Used by nearly 3,000 clinics, physical therapy centers, home health agencies and U.S. military hospitals, Anodyne Therapy delivers monochromatic near infrared photo energy through "therapy pads" – each containing 60 super-luminous diodes – placed directly on the skin to temporarily increase local microcirculation. The ability of photo energy to increase microcirculation, possibly through the release of nitric oxide, has been clinically documented.
A typical treatment, as described by Turtzo, involves placement of two pads on the bottom of the patient's foot and two on the lower leg – secured by soft neoprene straps – for 30 to 40 minute treatment sessions. A therapist will most likely prescribe a treatment regimen of 12 to 16 sessions, provided on a three-times-a-week schedule. The company sells two models of the Anodyne Therapy System, one for clinical settings and one for home use, with the clinical model accounting for a third of total sales, Turtzo said.
Turtzo noted that the majority of patients in the recent study had a mean age of 73 years and sensory loss at 7.9 sites of 10 sites, based on the SWM test, and were at "the highest risk for diabetic ulcers and amputations because they are unable to sense trauma to the bottom of their foot."
The trial examined, he said, "whether in fact Anodyne could improve the sensations in those patients once [their peripheral neuropathy] had gone to a very severe extent."
After treatments were administered using Anodyne Therapy in a clinical setting, the patients had an improvement in sensation to an average of only 2.3 sites with sensory loss, a mean improvement of 5.6 sites, the company reported.
"There was approximately a 70% improvement in the number of sites on average that the patient was able to feel after therapy compared to prior to therapy," Turtzo said.
He said the significance of this most recent trial is "that it was a very large study of over 1,000 patients" – Anodyne's biggest to date – and that "most of the participants in the other studies that we have published had peripheral neuropathy due to diabetes. In this study, 25% of patients had peripheral neuropathy that was unrelated to diabetes, and the results on those patients were the same as the results on those patients with diabetic peripheral neuropathy."
Anodyne Therapy also serves to restore sensation, Turtzo said, calling it a "very clinically relevant and very important treatment."
"We're substantially increasing circulation, so any condition that a patient might have that would benefit from an increase in localized circulation, Anodyne is effective for," Turtzo said. "Anodyne is a very safe and effective way to increase that circulation."
The system will be highlighted in an upcoming presentation on use of Anodyne Therapy in wound care at the 18th Annual Symposium on Advanced Wound Care later this month in San Diego.
Wound care is chief among Anodyne Therapy's other applications.
The company's continued research efforts in peripheral neuropathy include an ongoing study "in more than 2,000 patients which has results consistent with this [most recent] one, and also examines changes in neuropathic pain," Turtzo said. That study is in the peer review process and should be accepted for publication in two weeks, he said.