SOURCE: BioniCare Medical Technologies, Inc.

December 19, 2006 10:30 ET

New Published Data Suggest the Ability to Defer Total Knee Replacement for Patients With Knee Osteoarthritis

Viable Option for Patients With Severe Disease While Offering Less Cost to Insurance Companies

SPARKS, MD -- (MARKET WIRE) -- December 19, 2006 -- Today, BioniCare Medical Technologies, Inc. announced the publication of its total knee replacement (TKR) deferral study in Orthopedics highlighting the long-term safety and efficacy of the BioniCare Knee Device for patients with more severe osteoarthritis (OA) of the knee. A four-year study conducted at Johns Hopkins University demonstrated not only long-term pain and symptom relief, but also that significantly more patients who wore the BioniCare Knee Device were able to defer TKR versus those patients in a matched control group.

Propriety Pulsed Electrical Signal Provides Short-Term Pain Relief, Can Defer Surgery

"This study was a logical extension of our previous clinical trial efforts. The BioniCare Knee Device, which is the first and only non-drug, non-invasive pulsed electrical stimulated device cleared by the FDA for the management of knee OA, has proven itself effective in providing safe and effective relief patients who had failed medications with moderate disease. The most exciting element of this study is the focus on patients who had been recommended a total knee replacement, many with bone-on-bone OA," says Randy Murphy, President & CEO of BioniCare Medical Technologies, Inc. "The implications of these outcomes are profound because the data goes a long way to help us achieve our goal to improve patients' quality of life without the risks and complications associated with current medications and surgery. We have also modeled the savings to insurance companies who will pay significantly less if few total knee replacements are performed, and the results are no less dramatic."

This prospective, four-year, open label, multi-center study recruited 157 patients with moderate to severe knee osteoarthritis who had received a recommendation for a TKR by one or more orthopedic surgeons. Appropriate electrical placement of the electrodes is provided by a wrap that assures delivery of the signal at an optimal voltage that maximally stimulates the knee joint cartilage. Patients were asked to wear the BioniCare Knee Device for 6 to 10 hours per day, usually at night while sleeping. A control group matched for age, gender and weight consisted of 101 knee OA patients who received a primary total knee replacement at Johns Hopkins University. All patients had moderate to severe knee OA and were followed for at least four years or until they had a total knee replacement on the second knee.

Most Severe Patients Demonstrated The Most Dramatic Results

At the end of four years, 60 percent of BioniCare-treated patients with moderate to severe knee OA were able to defer a total knee replacement versus 35 percent in the matched control group. A more dramatic difference was seen in the group of patients with severe knee OA at baseline. At the end of four years, 62 percent of BioniCare treated patients deferred TKR versus 7 percent in the matched control group.

The only side effect recorded was a mild, transient skin rash in 45 percent of patients that usually disappeared by changing the type of electrode gel or by temporarily stopping treatment. Patients with rashes did not require additional treatment and they were able to continue therapy.

BioniCare Knee Device Offers Clinical Profile of Safety and Efficacy

The BioniCare Knee Device works through low amplitude electrical stimulation, and is the first and only non-drug, non-invasive electrical device available for OA of the knee. In a two-year open label study, patients who wore the device for more than 1750 hours experienced clinical benefit comparable to that of a total knee replacement. In addition, no patient has suffered a serious adverse event using the BioniCare Knee Device. Its benefits include the following:

--  Targeted, durable relief of pain and associated symptoms
--  Substantial improvement over baseline anti-inflammatory medications
--  Excellent safety profile
--  High patient acceptability
--  Ease of use
About BioniCare Medical Technologies, Inc.

BioniCare Medical Technologies, Inc. develops and markets devices to meet the growing needs of more than 70 million Americans who suffer from the painful complications of arthritis and related musculoskeletal diseases. Through application of its patented technology, BioniCare is dedicated to the discovery of non-invasive devices for the regeneration of musculoskeletal soft tissues to significantly improve the quality of patients' lives.

For more information about the company and the benefits of BioniCare's non-invasive, non-drug option for treating OA and RA, please visit or call 866-BIO-KNEE (866-246-5633).

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