Anodyne Therapy Receives Regulatory Approval from Health Canada for Treatment of Peripheral Neuropathy.

TAMPA, Fla. -- Anodyne(R) Therapy, LLC announced today that it has received regulatory approval from Health Canada to market its Anodyne Therapy Systems in Canada. Approved Canadian labeling, based on submission of published clinical studies, includes: temporary reduction in disturbances in skin sensation, increases in balance and reduction in fall risk (when used adjunctively with physical therapy) due to diabetic and other peripheral neuropathies.

Peripheral Neuropathy is nerve damage associated with diabetes and other chronic conditions, and the symptoms include numbness and/or pain in the feet, legs and hands. Complications of this devastating condition are reported to cost the U.S. healthcare system in excess of 37 billion dollars annually and include wounds that do not heal for months or years, lower extremity amputations, reduced mobility and increased risk of falls. While drugs are sometimes effective for the pain associated with diabetic peripheral neuropathy, no drug or medical device had previously been shown to increase sensation or improve balance once it has been diminished or lost due to peripheral neuropathy.

"We are pleased to be able to make Anodyne Therapy available to our Canadian neighbors and to have Health Canada recognize the significant clinical benefits associated with our products," said Craig Turtzo, CEO. "It is very rewarding to offer hope to people with peripheral neuropathy internationally, who, prior to Anodyne Therapy, did not have access to effective treatment options for their condition."

Anodyne Therapy treatments are currently available nationwide at more than 3200 outpatient therapy facilities, hospitals, nursing homes, physician offices and home health agencies to improve functional outcomes for patients suffering from peripheral neuropathy, chronic pain and a broad range of other health problems. Products are also available for convenient home use. For more information, visit http://www.anodynetherapy.com.

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