BioElectronics Overview 2015 | bielcorp. 1. BioElectronics Corporation content/uploads/2013/03/BioElectronics-Postoperative-Pain.pdf. Commentary.
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BioE lectronics Overview 2016 | www.bielcorp.com 2 Table of Contents Company Overview .. .. .. . 3 Product Portfolio .. .. .. .. 3 Prevalence and Problems of Chronic Musculoskeletal Pain .. .. . 3 Superior Safety to Analgesic Drugs .. .. .. 4 Benefits of ActiPatch/RecoveryRx .. .. .. .. 6 Chronic Pain & Central Sensitization .. .. .. . 7 Clinical Effects .. .. .. .. 7 Clinical Evidence .. .. .. .. . 10 Ongoing Clinical Research Studies .. .. .. . 10 New Studies .. .. .. .. . 10 Articles Published .. .. .. . 11 Randomized Controlled Trials .. .. .. . 12 A Randomized, Double Blinded, Placebo Controlled, Clinical Trial of Pulsed Shortwave Therapy in Osteoarthritis of the Knee .. .. .. . 12 Pulsed Radiofrequency Electromagnetic Field Therapy: A Potential Novel Treatment of Plantar Fasciitis .. .. .. .. 13 Control of Postoperative Pain with a Wearable Continuously Operating Pulsed Radiofrequency Energy Device: A Preliminary Study .. .. .. 14 Consumer Registry Study Data .. .. .. .. 15 A UK registry study of the effectiveness of a new over – the – counter chronic pain therapy 15 Menstrual Pan .. .. .. .. . 20 Heel Pain .. .. .. .. 23
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BioE lectronics Overview 2016 | www.bielcorp.com 3 Company Overview BioElectronics Corporation, headquartered in Frederick, Maryland, USA, is the leading company in the field on non – invasive electroceutical medical devices. The devices are used to treat acute and chronic pain and promote wound healing . pulsed shortwave therapy . Traditional pulsed shortwave therapies are clinically proven, effective, safe and have been used for decades by physicians and physiotherapists but are large devices for hospital or outpatient use. Advances in microelectronics have now made it possible to deliver this therapy in a small, wearable and economical medical device. devices provide superior extended duration treatments and hospital and home use to help self – management of pain and lower the cost of care. The devices do not prod uce heat or, a tingling sensation, like a TENS. Product Portfolio Prevalence and Problems of Chronic Musculoskeletal Pain Recent studies estimate the prevalence of chronic pain in the population to be about 20 40% , depending on how it is measured. Chronic pain affects more than the number affected by diabetes, heart disease and cancer combined. There is also a new focus on the costs of chronic pain with studies showing the extreme economic burden placed on healthcare systems and individuals 1 . Chro nic musculoskeletal pain is the cause of 80 – 85% of all chronic pain . Osteoarthritis is th e cause of 85% of all arthritis. One it occurs , it is irreversible and progressive with therapy focused on the reductions of symptoms and maintenance of quality of li fe. Chronic lower back pain , with a prevalence of 23% , is the leading cause of chronic musculoskeletal pain . Only the minority of people with chronic knee and hip pain opt to have a joint replacement to alleviate some of the symptoms. The main causes of pa in reported by US citizens include: low back pain (28.1%), neck pain (15.1%), knee pain (19.5%), shoulder pain (9.0%), finger pain (7.6%), and hip pain (7.1%).
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BioE lectronics Overview 2016 | www.bielcorp.com 4 A comprehensive European pain survey showed that 19% 3 of people suffer from moderate to severe chronic pain and the effects of which pervade all aspects of their lives: 66% less able to sleep 50% find walking and household chores difficult 40% have difficult with sexual relations 33% less able or unable to maintain an independent lifestyle 40 % feel helpless that they cannot function normally 60% less able to work outside the home 20% had lost their job due to pain 30% who were not retired said their hours or employment status had been effected Increased depression and doubles suicide risk The high prevalence of chronic musculoskeletal pain is clear evidence of the ineffectiveness and inadequacy of the currently available therapeutic options. There are no consistent and dependably effective analgesic treatments . The e scalating doses and drug co mbinations do not provide effective pain relief and result in increasing incidence of adverse effects and serious harm, particularly in an ageing population that are less tolerant of drugs. Many patients are intolerant of non – steroidal anti – inflammatory dr ugs (NSAIDs) as well as opioids R ecent studies have shown that acetaminophen (paracetamol) is ineffective for relieving chronic musculoskeletal pain 4 . Chronic use of opioids and NSAIDs negatively impact public health, and society 5 . The stark reality is that for a very significant percentage of the population, suffering from moderate to severe chronic pain no appropriate alternative therapy is available . ActiPatch would provide a valuable new mode of chronic pain therapy and result i n substantial public health benefits by reducing the burden of pain, the complications of its treatment, as well as associated healthcare costs. 1. Baker M, Collett B, Fischer A et al . Improving the current and future management of chronic pain . A Europea n Concensus Report (2010). 2. Gaskin DJ, Richard P. The economic costs of pain in the United States . J. Pain 13(8), 715 – 724 (2012). 3. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D: Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment . Eur. J. Pain 10(4), 287 – 333 (2006). 4. Machado GC, Maher CG, Ferreira PH et al. Efficacy and safety of paracetamol for spinal pain and osteoarthritis: systematic review and meta – analysis of randomised placebo controlled trials . BMJ 350 , h1225 (2015). 5. Momeni M, Katz JD. Mitigating GI risks associated with the use of NSAIDs. Pain Med. 14 Suppl 1, S18 – 22 (2013). Superior Safety to Analgesic Drugs ActiPatch is completely safe with no risk of heat injury or any other significant adverse events. O ver one million devices have been used and no serious adverse events have been reported. Drug therapy is the mainstay of chronic musculoskeletal pain treatment and all drugs have wide ranging adverse effects. The major problems and issues of the most commonly used drugs for musculoskeletal pain are set out below: Acetaminophen Liver failure – In the U.S., acetaminophen toxicity has replaced viral hepat itis as the most common cause of acute hepatic failure , and is the second most common cause of liver failure requiring transplantation Kidney Injury Gastrointestinal Bleeding According to the Centers for Disease Control and Prevention, between 2001 and 201 0, more than 1,500 people in the U.S. died from accidental acetaminophen overdoses . T his number is far higher than any other over – the – counter pain reliever. NSAIDs NSAIDs are a leading cause of drug – related morbidity especially in the elderly and patien ts with co – morbidities. The mechanisms of NSAID toxicity are well understood, but the consequences are largely uncontrolled in
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BioE lectronics Overview 2016 | www.bielcorp.com 5 clinical practice. GI ulcers, including bleeding ulcers, may occur in several percent of all chronic unprotected, high – dose NSAID users. Renal side effect s may precipitate renal failure resulting in acute dialysis and chronic retention. This includes sodium retention resulting in arterial hypertension, heart failure, and atherosclerotic events. Cardiovascular risk may be tripled by chronic high – dose NSAID use in long – term clinical trials though “real – life studies” that indicate lower risk ratios. Off – target side effects include allergic reactions, drug – induced liver injury, and central nervous system effects. Gastrointestinal bleeds – annual risk of serious GI complication is 1.3 % for Rheumatoid Arthritis and 0.73% for Osteoarthritis o 100,000 hospital admissions per year in U.S. o 16,000 Deaths per year o Need for co – prescribing proton pump inhibitors Kidney Injury o Adverse renal events occur in approximately 1 – 5% all patients using NSAIDs o Because of the large number of patients that take NSAIDs (U.S. estimates of more than 70 million prescriptions and 30 billion over – the – counter doses annually), this translates to up wards of 2.5 million patients experiencing a nephrotoxic event annually . Bleeding Heart failure Hypertension Increased risk of heart attack, stroke and DVT Drug interaction particularly with anticoagulants and anti – platelet drugs Hearing loss The American College of Rheumatology , and other rheumatologic associations around the world , recommend use of NSAIDs at the lowest effect ive dose and for short duration and they be limited to mainly control flare ups. This leaves many chronic pain sufferers with the di lemma of running the risk of adverse effects from chronic NSAID use , or moving onto opioids with their own inherent and potentially worse problems and risks. Opioids An analysis by the Centres for Disease Control and Prevention (CDC) found that opioid an algesic sales increased four – fold between 1999 and 2010 and paralleled by an increase in opioid overdose deaths and substance abuse treatment admissions during the same time period. . 1 in 15 people who take non – medical prescription pain relievers will try heroin within 10 years. In 2010, 1 in 20 people in the US (age 12 or older) reported using prescription painkillers for nonmedical reasons In 2012, there were 16,000 deaths in the U.S. from using opioid s and 6,000 from heroin. An estimated 2.1 million suf fer ed from prescription opioid substance abuse and an estimated 467,000 were addicted to heroin. 58% of people dying from prescription opioid overdoses have a history of chronic pain . Favorable Efficacy Recent evidence has demonstrated that acetaminophen has little efficacy in chronic spinal and osteoarthritis pain. Efficacy of long term NSAIDs and opioid use in chronic musculoskeletal conditions of the spine and knee is also limited. Statistically significant and clinically meaningful pain reduction has been demonstrated in three ActiPatch RCTs, two in chronic and one acute musculoskeletal pain. The consumer data from 4187 respondents, 3 , 595 with chronic pain, had an average baseline Visual Analogue Scale (VAS) score of 8.02 (scale is 0 – 10), and demonstrated an average of 41% reduction in chronic knee pain and 37% reduction in chronic back pain. The consumer data has been bias tested and the placebo effects from the ActiPatch RCTs range from 3.9 – 7.0% so the effect is more than likely to be ve ry real. The consumer data demonstrates a consistent clinically
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BioE lectronics Overview 2016 | www.bielcorp.com 6 meaningful effect in chronic musculoskeletal pain from osteoarthritis, rheumatoid arthritis, fibromyal gia, post – surgical, and neuropathic affecting different regions of the body (back, hip, kn ee, wrist, elbow, and shoulder). The magnitude of the beneficial effect compares very favourably with current analgesic pain medications. Choice of analgesic is not based solely on efficacy, as safety is very important. The ActiPatch risk/benefit profile is superior to all analgesic drugs. Furthermore, in the ActiPatch consumer data, effectiveness was demonstrated in people who on average had very high baseline pain scores and were already on two modes of analgesics therapy without good effect. Benefits of ActiPatch/RecoveryRx The ActiPatch device provides treatment continuously for 720 hours for constant and consistent pain relief . The ActiPatch mechanism of action provides a unique analgesic profile of decreasing local pain sensitivity of the affecte d region due to an anti – inflammatory effect as well as decreasing central pain perception by a neuromodulation effect; The new non – drug analgesic modality that provides statistically significant and clinically meaningful pain relief; Absolute safety due to novel low power mechanism of action; Reduction or avoidance of analgesic drug use and lowering the risk of adverse effects, including death from opioids and NSAIDs; Alternative analgesic for those who are intolerant or unwilling to take drugs; Reducing po tential for harmful drug interactions e.g., NSAIDs and anticoagulants or anti – platelet drugs (both increasingly common in the aging population); and Easy to use and cost effective with less need for advanced pain interventions.
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BioE lectronics Overview 2016 | www.bielcorp.com 8 Device Description The device is constructed from three main components: an integrated circuit, an antenna and a 3 Volt battery. The circuitry consists of digital/analog electronics that control the timing functio ns to produce the therapeutic radiofrequency (RF) field at the pre – set pulse frequency. This closed loop system of the antenna, low energy signal generator circuit, and battery power supply , transfers the RF energy to the target tissue as a localized therapy with no far field effects. ActiPatch delivers a pulsed RF treatment by way of a flexible induction coil that is placed over the area to be tr eated as illustrated below. The entire unit is wrapped in soft stretchable laminate material. Device Activation & Use The button switch is depressed for 2 – 3 seconds and then released . A green light will be illuminated confirming device is on and ready for use. To turn off the device, the b utton switch is again depressed for 2 – 3 sec onds and then released. The green light will turn off confirming that the device is no longer active. Last approximately 720 hours = 30 days continuous use If the green light no longer illuminates, then the device is no longer operational and should be disposed. ActiPatch can be applied in several ways: A ffixed to the skin over the area to be treated with standard medical adhesive strips; U sed with wraps for the knee and back to hold the device in place over the target area; More than one ActiPatch device can be worn as long as they do not overlap. Application s Included: Back Wrap: Knee Wrap: Medical Adhesives: Optional Methods: Affix to clothing that is in close proximity to the body over the target area of treatment Applied over medical dressings and plaster casts overlapping.
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BioE lectronics Overview 2016 | www.bielcorp.com 9 ActiPatch produces a durable response with no loss of effectiveness over extended durations of usage. In chronic musculoskeletal pain, the device has been shown to provide over 60% benefit within 3 days of continuous use and most of those who respond will do so by day 5. Chronic pain sufferers most likely have had the pain for years . What is i mportant to them is that they experience pain relief rather than an immediate onset of action. The pathophysiology of acute pain is different to chronic pain allowing ActiPatch to work much more quickly providing an effective non – drug alternative for acu te musculoskeletal pain. Precautions & Safety ActiPatch® should not be used by women who are pregnant or think they may be pregnant as no studies have been conducted in pregnancy. ActiPatch® is not a sterile device . For post – operative or other wounds, place over sterile dressings. ActiPatch® will not interfere with other electronic equipment in use. ActiPatch® should not be used by skeletally immature persons (under 16 years of age). Do not attempt to modify this device or replace the battery. Once the LED light stops coming on the device is no longer operational and can be disposed of.
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BioE lectronics Overview 2016 | www.bielcorp.com 10 Clinical Evidence Clinical trials play a crucial role in testing new treatments and therapies. BioElectronics has undertaken clinical trials, user studies and compiled patient testimonials to build up the clinical evidence for its unique medical device product range. Many of the trials have been published in high ranking peer reviewed journals . For example, a plantar fasciitis heel pain clinical study was published in the respected journal; The Journal of Foot and Ankle Surgery . Although we believe we have combined a considerable amount of high quality clinical evidence , we are undertaking a significant number of new clinical trials to further develop the medical application and bring attention to our products. These clinical trials are being undertaken in respected universities and research hospitals by experienced and well published clinical researchers from around the world. Significant progress has b een made on this front, with clinical trials on three musculoskeletal pain conditions, plantar fasciitis, acute lower back and osteoarthritis of the knee. Two studies are being conducted on postoperative pain, hernia recovery and 3 rd molar extraction. An i ndependent study is also being conducted on venous stasis ulcer wound healing and pain management. Ongoing Clinical Research Studies Study Principal Investigator Primary Outcome Measure Enrolment Status Bilateral Hernia Surgical Recovery Dr. Frederik Berreveot University Hospital Ghent, Ghent, Belgium Analgesic medication use and pain over 7 day recovery. 20 bilateral 60 unilateral May 2015 (4 bilateral patients to completion) Dental Implant Dr. Operti, Dr Tealdo Valle Belbo Implant Center, Italy Pain and Edema at day 3 and day 5 60 Recruiting Complete Dec 2015 Chronic Back Pain Prof. Tipu Aziz Oxford University, John Radcliffe Hospital VAS pain at 10 days 40 Started June 2015 Chronic Back Pain Prof. Tipu Aziz BackCare UK Charity VAS pain at 10 days 90 Pending Ethics Approval New Studies Migraine Pilot To investigate the effect of ActiPatch in Chronic Migraine. Prof Martelletti Chief of the Headache Centre, Saint Andrea Hospital, Rome, Italy. World name in headaches. Vice President European Headache Federation. Understands neuromodulation and is interested. 60 – 80 patient study $60,000 – $100,000. Diabetic Foot Neuropathic Pain Pilot To investigate 3 months foot pain relief on diabetic patients cost for 40 patients $20,000.
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BioE lectronics Overview 2016 | www.bielcorp.com 11 Articles Published Study Journal Publication Date Estimate Author Institution Blepharoplasty Aesthetic Plastic Surgery Published 1982;6(3):169 – 71 Frederick V. Nicolle, Richard M. Bentall London, United Kingdom Soft Tissue Injury Bioelectrochemistry and Bioenergetics Published 1986;16 , 531 548. Richard Bentall Institute of Bioelectrical Research Postoperative Pain Aesthetics of Plastic Surgery Published: 2012 Apr;36(2):458 – 63 Rawe IM, Lowenstein A, Barcelo CR, Genecov DG Genecov Plastic Surgery Group Dallas, Texas Chronic Wound Case Study International Wound Journal Published: 2012 Jun;9 (3):253 – 8 T. Vlahovic, IM Rawe Temple University Philadelphia, PA Plantar Fasciitis Journal of Foot and Ankle Surgery Published: 2012 May June;51(3):312 – 6 Brook J, Dauphinee DM Korpinen J, Rawe IM Hunts Regional Medical Center Greenville, Texas Oesteoprogeniter Cell Differentiation Into Bone Journal of Craniofacial Surgery Published 2012 Mar;23(2):586 – 93 Dr. Russell Reid University of Chicago Medical School PEMF Review Wound Healing Wounds International Published 20012 3(4):32 – 34 Ian Rawe BioElectronics Case for OTC use of shortwave therapy Pain Management Published 2014 Jan;4(1):37 – 43 Ian Rawe BioElectronics OA of the Knee Rheumatology Published Dec 2015 Dr. G. Bagnato University Hospital Gaetano Martino, Messina, Italy
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