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BioniCare Electrotherapy
Closing the Therapeutic Gap Between Drugs and Surgery for Osteoarthritis of the Knee

The BioniCare Knee Device is the first and only non-drug, non-invasive treatment for osteoarthritis of the knee. The Device is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by physicians' global evaluation (see clinical studies). It fills a large, unmet need in the current treatment paradigm and has an excellent safety profile.

The Device represents a safe and effective option for the management of osteoarthritis of the knee for patients whose pain and other symptoms are not controlled by appropriate drug therapy alone, and who are unable or unwilling to undergo knee replacement surgery.

Safe and Effective

The Knee Device delivers a specific electrical signal to create a new kind of therapy.
  • Targeted relief of pain and associated symptoms
  • Substantial improvement over baseline NSAID therapy
  • Excellent safety profile
  • Easy for patients to use
Rigorously Conducted Clinical Studies Put the BioniCare Knee Device to the Test

A multicenter, prospective, randomized, placebo-controlled clinical study was conducted to evaluate the safety and efficacy of the BioniCare Knee Device in the management of osteoarthritis of the knee. Patients were maintained on NSAID and/or analgesic therapy throughout the study and were randomly assigned use of an active or inactive (placebo) BioniCare Knee Device for 4 weeks.1

Significantly Improved Pain Relief

Pain relief with the BioniCare Knee Device was significantly greater than with NSAID therapy and/or analgesics alone. For time-compliant patients who used the Device 6 - 10 hours per day, the improvement was even more substantial.1
 


Excellent Safety Profile

Traditional treatment options may be limited by medication side effects or risks and the aftereffects of invasive procedures. In all the Knee Device clinical studies, the only reported side effect was a mild, generally transient skin rash caused by the electrode gel. The rash was controlled by changing gels, using a non-prescription topical medication, or by discontinuing use for a few days.2

Easy for Patients to Use
  • The BioniCare Knee Device is flexible and lightweight enough to be worn under clothing and during sleep
  • The soft wrap closes with VelcroŽ to ensure a precise, comfortable fit
  • The Knee Device can treat two knees simultaneously by using a second wrap
  • The Device delivers a low-amplitude pulsed electrical field
  • Patients cannot feel the electrical signal during treatment

Verifiable Compliance

Patients are instructed to use the Knee Device 6 or more hours each day. Most use the Device while asleep or relaxing at home. Research shows increased effectiveness as the daily treatment time is increased - 8 hours of daily treatment is more effective than 6 hours, and 10 hours is more effective than 8 hours. A clinical study confirmed that many patients experienced dramatic improvement in pain and symptoms after they used the device for 750 hours or more. The BioniCare Knee Device records patient use, so both patient and physician can verify compliance.

1. Data on file. BioniCare Medical Technologies, Inc., Sparks, Maryland

2. Zizic TM, Hoffman KC, Holt PA, et al. The treatment of osteoarthritis of the knee with pulsed electrical stimulation. (J Rheumatol.1995;22:1757-1761.)

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