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 continuing research with experts from Johns Hopkins and the University of Pennsylvania, BioniCare is developing unique methods to treat symptoms and improve function in patients with arthritis.

The BioniCare Knee Device is the first and only non-drug, non-invasive option cleared by the FDA in the U.S. for reducing pain and symptoms associated with osteoarthritis (OA) of the knee and for overall improvement of the knee as assessed by physician's global evaluation. With over 10 million people who suffer from knee pain due to osteoarthritis, BioniCare now offers a new treatment option. This pulsed electrical stimulator provides lasting pain relief by targeting the connective tissue in the knee joints.

In order to feel the greatest relief of pain and symptoms, it is important that patients use the BioniCare Knee Device as recommended for 6-10 hours each day. Because of its practical design, it can be worn either during the day or at night. However, since wearing the device may limit some daytime activities, we recommend that the BioniCare Knee Device be worn at night while sleeping to maximize comfort.

The length of time before relief is felt can vary greatly from person to person. Based on clinical studies, some patients may experience benefit within the first month. However, in the majority of patients, it may take up to 4-6 months to see improvement. A recent study showed that many patients experienced dramatic improvement in pain and symptoms when they had used the device for at least 750 hours or more.

THE BIONICARE KNEE DEVICE
The System has three major components:

   1. Signal Applicator
      This black, soft wrap closes with Velcro to ensure a precise, comfortable fit. It is flexible, lightweight, and easy to wear and holds the contact elements/electrodes in place. There is a suspended strap and waste band to include with the device for those patients who wish to wear it throughout the day. Otherwise, the additional pieces are not necessary since most patients use this while they are sleeping. Signal applicators come in different designs and sizes to fit the treatment site and the individual.
   2. Signal Generator
      Weighing approximately 4 oz., this small battery-powered unit generates the proprietary, sub-threshold electrical signal that provides the therapy. The System uses a rechargeable 9-volt battery, and keeps a record of treatment. The Signal Generator has two channels so that when used with two Signal Applicators it can treat two knees simultaneously.
   3. Contact Elements
      Snap in electrodes that are replaceable. Two electrodes are used: a treating electrode over the affected joint (knee) and a return electrode (thigh).

INSTRUCTION FOR USE OF THE BIONICARE KNEE DEVICE
It is recommended that the patient wear this device while they are sleeping for at least 6 to 10 hours per day. It is also recommended that a patient use this device for at least 4 to 5 months before experiencing significant results.

   1. The patient spreads the BioniCare conductive electrode gel evenly over the two contact elements.
   2. The signal applicator device is then wrapped around the knee and thigh, making sure that one contact element covers the knee while the other is on the thigh.
   3. The patient connects the lead wire from the signal applicator to the signal generator.
   4. Once the wires are connected, the patient turns the device on and adjusts the voltage until a low-grade tingling sensation is felt.
   5. Upon feeling the tingling sensation, the patient dials back the voltage to just under the point at which tingling was felt.
      � It is the duration of use, not the strength of the voltage that results in superior clinical benefit.
   6. The patient then clips the signal generator to either the wrap or clothing, and wears the device for at least six hours.
   7. Make sure you are using a fully charged battery. The other battery should be charging.

Contraindications

•  Do not use the BioniCare Knee Device for any contact element (electrode) placement that applies current to the carotid sinus (neck) region
•  Do no use the BioniCare Knee Device on patients who have a demand-type cardiac pacemaker
•  Do not use the BioniCare Knee Device for any contact element (electrode) placement that causes current to flow transcerebrally (through the head)
•  Do not use the BioniCare Knee Device whenever pain syndromes are undiagnosed until etiology is established

Warnings

•  The safety of the BioniCare Knee Device for use during pregnancy or birth has not been established
•  The BioniCare Knee Device is not effective for pain of central origin (this includes headache)
•  The BioniCare Knee Device is a prescription device that should be used only under the continued supervision of a physician
•  The BioniCare Knee Device has no curative value
•  The user must keep the BioniCare Knee Device out of reach of children
•  Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when the BioniCare Knee Device is in use

Precautions

•  Isolated cases of skin irritation may occur at the site of contact element (electrode) placement following long-term application
•  Effectiveness is highly dependent upon patient selection by a person qualified in the management of arthritis

REFERENCES:
Lippiello L, Chakkalakal D, Connolly JF. Pulsing direct current induced repair of articular cartilage in rabbit osteochondral defects. J Orthop Res.1990;8:266-275.

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

Wang W, Wang Z, Brighton CT, et al. Up-regulation of chondrocyte matrix genes and products by electric fields. Clinical Orthop 2004; 427S:S163-173.

Mont MA, Hungerford DS, et al. Electrical Stimulation Helps Delay Knee Replacement Surgery. BioMechanics 2005; 12: Issue 5 2005; 12: Issue 5