Chronic Pain Therapy Pain & Trauma Category Award Winner BioElectronics Corporation ActiPatch Pharmacist Training 11-20-15
Education Kenneth McLeod, Ph.D. PhD in Electrical Engineering, MIT, 1985 Post-Doctoral Fellowship, Tufts University, Anatomy and Cell Biology Research Director, Dept. of Orthopaedics, Stony Brook University, NY Founding Dept. Chair Bioengineering, Binghamton University, NY Current Position Director Clinical Science and Engineering Research Center Entrepreneur in Residence Principal research area Adaptation of living tissue to physical factors Electromagnetic interactions with living tissue (ELF to IR-C) Technology development 25 patents; FDA PMA and 510(K) experience Founder and Consultant to Bioelectronics since 1999 BioElectronics Corporation www.bielcorp.com 2
Chronic Pain & Central Sensitization Nearly 1/3 of adults suffer with chronic pain Drug therapies have limited effectiveness as chronic pain is often due to central sensitization (CS) CS results in pain amplification Allodynia Pain due to non-painful stimuli Hyperalgesia Exaggerated pain Chronic pain poorly correlates to level of peripheral tissue injury indicating CS Perceived Pain Ascending input to brain Pain transmitting to spinal cord Source of pain Descending modulation BioElectronics Corporation www.bielcorp.com 3
ActiPatch Mechanism of Action ActiPatch is a non-invasive electromagnetic stimulation device Delivers low energy radio frequency pulses, 1,000 times a second ActiPatch negates CS by modulating sensory nerve activity Dampens brain s perception of pain signals Results in reduced chronic pain Pulsed signal prevents adaptation Allows for long-term use ActiPatch therapy reduces chronic pain resulting in improved sleep, physical function & quality of life BioElectronics Corporation www.bielcorp.com 4
ActiPatch Chronic Pain Registry Data 5,005 subjects: Mean baseline VAS - 8 on a 10 point scale 2/3 of 7-Day ActiPatch Trial users report more than 50% pain relief Long term Use: 2/3 (including opioid users) reported moderate to complete elimination of pain medication More than 2/3 users reported improved sleep quality 3/4 users reported increased physical activity More than 4/5 users reported a substantial improvement in overall quality of life Source: A UK registry study of the effectiveness of a new over-the-counter chronic pain therapy http://www.futuremedicine.com/doi/full/10.2217/pmt.15.35 BioElectronics Corporation www.bielcorp.com 5
Supporting Clinical Studies Knee Osteoarthritis - statistical significance P <0.05: Reduces Pain 25% VAS, 23% WOMAC v 3% Placebo Reduces Stiffness 24% v 7% Placebo Reduces Inflammation/Effusion 75% v 18% Placebo Reduces Consumption of Analgesics 59% v 4% Placebo Improves Function 16 % 0.2 Placebo Plantar Fasciitis The morning VAS score on day 7 was 40% lower than the morning VAS score on day 1; placebo group showed a 7% reduction (p = 0.03) Sub-muscular Breast Surgery Significantly less pain on 6 of the 7 postoperative days. By day 7, VAS in the treatment group was 5 times lower than in the placebo group Knee Comparative Efficacy from a Meta-analysis 39% more effective than max efficacy of Opioids; 85% more effective than max efficacy oral NSAIDs; 109% more effective than topical NSAIDs Please visit www.bielcorp.com/clinical-evidence/musculoskeletal-pain/ for complete information. BioElectronics Corporation www.bielcorp.com 6
The ActiPatch Device Loop of the device should be placed directly over the source of the pain. Press button to activate. BioElectronics Corporation www.bielcorp.com 7
ActiPatch Attachment Methods Back Pain Knee Pain Muscle & Joint Includes: Reusable back wrap Includes: Reusable knee wrap Includes: Medical adhesives Therapy works through tight fitting clothing and bandages. You can wear more than one ActiPatch medical device at a time just as long as the devices are not overlapping. Over-the-counter (OTC), easy to use, and affordable ( 24.99), ActiPatch provides 720-hours of on/off therapy, or 3 pence an hour for superior pain relief. VIDEO: Products available for pain relief https://youtu.be/ijy2mttb3xs BioElectronics Corporation www.bielcorp.com 8
ActiPatch - Use & Safety Pain relief may take up to 7 days Recommended use time is 24/7 for first week After the first week: Daily treatment may be continuous, or intermittent Overnight therapy is an effective option for many ActiPatch users There is no sensation when using the ActiPatch Safety Safe for diabetics, arthritics and the elderly No serious adverse events reported Safe with implanted metalwork Safe with Pacemakers - Avoid placing directly over pacemaker on chest Not recommended for pregnant women or children (as a general precaution) Adverse events may include skin irritation; this may be avoided by attaching on outside of clothing VIDEO: What you will feel when using ActiPatch http://youtu.be/y1mvp2wsf_u BioElectronics Corporation www.bielcorp.com 9