PROVEN NON-INVASIVE TREATMENT FOR RHEUMATOID ARTHRITIS

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Adelia Manning
10 years ago
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1 PROVEN NON-INVASIVE TREATMENT FOR RHEUMATOID ARTHRITIS

3 BIONICARE HAND SYSTEM Non-drug, non-invasive Adjunctive therapy For patients symptomatic despite current therapy For patients intolerant to drug therapy For patients wanting an alternative Clinically proven to reduce pain and stiffness

4 BIO-2000 Touch-screen interface Slim and compact Web-based reporting capabilities GENERATOR DOCK Wireless system Universal Low-profile Generator easily snaps into place GLOVE BIO-2000 CONDUCTIVE SYSTEM Easy to apply Comfortable Targeted stimulation to each hand and wrist joint* Conductors facilitate signal transmission *Proven in finite element analysis GENERATOR DOCK CONDUCTORS

5 PROVEN NON-INVASIVE TREATMENT FOR RA A multi-center, prospective, double-blind, randomized, placebo-controlled clinical study to evaluate the safety and efficacy of the BioniCare Hand Device in the management of RA hand pain. 89 patients 6 centers Patients treated with BioniCare 8 ( ± 2) hours per day for 4 weeks Patients maintained on stable doses of NSAIDs, DMARDs and/or analgesics throughout the study PATIENTS EVALUATION OF PAIN AND SYMPTOMS PATIENT EVALUATION OF FUNCTION PHYSICIAN S GLOBAL EVALUATION Improvement from the Baseline Improvement from the Baseline Improvement from the Baseline IMPROVEMENT (VAS) IMPROVEMENT (VAS) IMPROVEMENT (VAS) Week 1 Week 2 Week 3 Week4 0.0 Week 1 Week 2 Week 3 Week Week 1 Week 2 Week 3 Week 4 Active (N=45) Placebo (N=44) Active (N=45) Placebo (N=44) Active (N=45) Placebo (N=44) 73% GREATER IMPROVEMENT in patient evaluation of pain and symptoms 80% GREATER IMPROVEMENT in patient evaluation of function 40% IMPROVEMENT in disease activity

6 BIONICARE SCIENCE Rheumatoid arthritis is characterized by the degradation of the joint by inflammatory cytokines. Scientific research supports the hypothesis that electrical signals can increase aggrecan and Type II collagen synthesis and decrease inflammatory cytokines involved in the inflammation of rheumatoid arthritis. 1,2 The BioniCare signal has been proven to reduce pain and medications, increase function, defer surgery and improve the overall condition of synovial joints. The BioniCare Hand System signal has been proven to decrease the pain and symptoms of rheumatoid arthritis of the hand. 3 1 Brighton CT, Wang W, Clark CC. The effect of electrical fields on gene and protein expression in human osteoarthritis cartilage explants. J Bone Joint Surg Am Apr;90(4): Wang W, Wang W, Zhang G, Clark CC, Brighton CT. Up-regulation of chondrocyte matrix genes and products by electrical fields. Clin Orthop Relat Res Oct;(427 Suppl):S Zizic TM, Hoffman KC, He YD, Caldwell JR, Deal C, Holt PA, Hungerford DS, Jacobs MA, Klaussen LW, Krackow K, O Dell JR, Smith C. The treatment of rheumatoid arthritis of the hand with pulsed electrical fields. Electricity and Magnetism in Biology and Medicine. New York: Kluwer Academic/Plenum 1999,

7 TRACK COMPLIANCE AND MEASURE PROGRESS! BIO-2000 patient usage data and personalized outcome responses are uploaded and tracked at Patients can print progress report that can be shared during office visits Review usage and efficacy to assist in treatment planning Provides resources for your patients: track progress news stories links to arthritis information tips for healthy living information about the BIO-2000 device *Patient access requires software installation and registration Participation in the BioniCare.com web site is voluntary. The device provides complete treatment without any connection to the web site.

8 INDICATION The BioniCare Hand System is indicated for use as an adjunctive therapy in reducing the level of pain and stiffness associated with pain from rheumatoid arthritis of the hand. CONTRAINDICATIONS Do not use the BioniCare Hand System for any electrode placement that applies current to the carotid sinus (neck) region. Do not use the BioniCare Hand System for any electrode placement that causes current to flow transcerebrally (through the head). Patients with demand type cardiac pacemakers should consult with their physician prior to use of this system. Do not use the BioniCare Hand System whenever pain syndromes are undiagnosed, until etiology is established. WARNINGS The BioniCare Hand System must be used only as prescribed and applied only to the hand. The safety of the BioniCare Hand System for use during pregnancy has not been established. The BioniCare Hand System is not effective for pain of central origin (including headache). Use only under the continued supervision of a physician. Keep out of reach of children. Electronic monitoring equipment (such as ECG monitors and ECG alarms) may not operate properly when the BioniCare Hand Device is in use. CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician or any other practitioner licensed by the law of the State in which he practices. WARNINGS: If you experience pain, swelling, sensation changes, or unusual reactions while using this product, contact VQ OrthoCare s Patient Care department at or consult a physician. PRECAUTIONS Isolated cases of skin irritation may occur at the site of conductors or conductive glove placement following long-term application. Effectiveness is highly dependent upon patient selection by a physician qualified in the management of arthritis Mitchell South Irvine,CA VisionQuest Industries, Inc. VQO511647REVB

Corporate Medical Policy

Corporate Medical Policy Electrical Stimulation for the Treatment of Arthritis File Name: Origination: Last CAP Review: Next CAP Review: Last Review: electrical_stimulation_for_the_treatment_of_arthritis