Much of our coverage of technologies that send pulses of electricity into the body involves the brain. For example, just recently we covered transcranial direct-current stimulation (tDCS), which is being tested for its potential cognitive benefits. We were recently contacted by BioElectronics Corporation, which develops “electroceuticals” primarily for pain reduction and healing. We had an opportunity to speak with their executive vice president, Dr. Deepak Kotak, about how these devices work and what the evidence is surrounding them.
Shiv Gaglani, Medgadget: What exactly are electroceuticals?
Dr. Deepak Kotak: Electroceutical (like nutraceutical) is a broad term that describes a category of devices that use electricity to heal body tissues. The devices use a variety of forms of energy and can be implanted or delivered right on the skin as ours do, or the energy waves can be sprayed as was done with the older high power forms of therapy. At BioElectronics we like the term Bioelectroceutical because it vividly suggests the biological effect that’s created by our pulsing radio wave.
Medgadget: How do these work?
Kotak: Our Bioelectroceutical devices (like ActiPatch Therapy) emit a pulsing shortwave radio wave to create an imperceptible electrical field in the body’s tissues to modulate sensory nerves and reduce pain. This tricks the brain into thinking it’s not in pain.
At the same time it starts a healing cascade effect that influences motor nerves to stimulate blood flow in the treatment areas. You can actually see it work in photos of bruises before and after treatment. The increased flow reduces swelling and bruising and speeds up the healing. The BioElectronics products include: ActiPatch Therapy for musculoskeletal pain and injuries such as back, knee, wrist or elbow; RecoveryRx Therapy for post-surgical incisions and chronic wounds; Allay Therapy for menstrual pain and HealFast Therapy for treating dogs, cats and horses. There is even a product for plantar fasciitis, heel pain, called ActiPatch SMART Insole.
Medgadget: Are there any clinical trials that show efficacy?
Kotak: Yes, absolutely. Since its inception BioElectronics researchers have worked with the world’s leading medical research hospitals and universities on studies to both improve its products and expand the ways in which this technology can be used to reduce pain without drugs and speed healing in soft tissues. BioElectronics has compiled a 148-page Mechanism of Action and Clinical Evidence document that is a summary of clinical studies that can be downloaded here.
BioElectronics is collaborating with on-going clinical studies at the following leading medical institutions:Tufts Medical and Dental School, University of Chicago Medical School, University of British Columbia, University Hospital Ghent, Belgium, University Hospital G. Martin, Messina, Italy and University of Dunedin, Otago, New Zealand
Below is a list of recent publications:
Published Clinical Literature
Rawe, I. M. (2014) The Case for Over-the-Counter Shortwave Therapy: Safe and Effective Devices for Pain Management, Pain Management Journal January 2014, Vol. 4, No. 1, Pages 37-43 www.futuremedicine.coRawe I (2012) Pulsed radio-frequency electromagnetic field (PEMF) therapy as an adjunct wound healing therapy. Wounds International 3(4):32-34
BioElectronics Published Studies
Brook, J., Dauphinee, D. M., Korpinen, J., and Rawe, I. M. (2012) Pulsed radiofrequency electromagnetic field therapy: a potential novel treatment of plantar fasciitis, J Foot Ankle Surg 51, 312-316.
Nicolle, F. V., and Bentall, R. M. (1982) Use of radio-frequency pulsed energy in the control of postoperative reaction in blepharoplasty, Aesthetic Plast Surg 6, 169-171.
Rawe, I. M., Lowenstein, A., Barcelo, C. R., and Genecov, D. G. (2012) Control of postoperative pain with a wearable continuously operating pulsed radiofrequency energy device: a preliminary study, Aesthetic Plast Surg 36, 458-463.
Rawe, I. M., and Vlahovic, T. C. (2012) The use of a portable, wearable form of pulsed radio frequency electromagnetic energy device for the healing of recalcitrant ulcers: a case report, Int Wound J 9, 253-258.
Teven, C. M., Greives, M., Natale, R. B., Su, Y., Luo, Q., He, B. C., Shenaq, D., He, T. C., and Reid, R. R. (2012) Differentiation of osteoprogenitor cells is induced by high-frequency pulsed electromagnetic fields, J Craniofac Surg 23, 586-593.
Bentall, R. H. C. (1986) Low-level pulsed radiofrequency fields and the treatment of soft tissue injuries.,Bioelectrochem Bioenerg 16, 531–548.
Medgadget: Can you discuss the safety considerations and regulatory approvals that are needed?
Kotak: In the United States, BioElectronics products are cleared by the FDA for the treatment of edema following blepharoplasty. Purchase of the human products, ActiPatch Therapy, RecoveryRx and Allay requires a prescription from a health care professional. BioElectronics is seeking OTC approval in the US as it has in the rest of the world. HealFast Therapy for pets and horses is available OTC online at www.healfasttherapy.com and through veterinarians.
In international markets, the product is consistently classified as a low risk OTC product. In Canada, BioElectronics products are Class II devices and are sold over-the-counter. Health Canada has approved the devices for relief of pain associated with musculoskeletal complaints, relief of menstrual pain, and postoperative OTC
In the European Union (CE mark) the devices are approved as Class II devices for edema reduction, swelling, pain and inflammation over the counter (OTC). Australian TGA (Therapeutic Goods Administration) has given OTC approval as a Class IIa device for the reduction of pain and inflammation. Additionally, in Korea, ActiPatch is cleared for the reduction of muscle pain in the back, knee, wrist, elbow and heel.
The products have clearance in more than 50 countries around the world. The safety of the products is clearly proven. The company has sold 500,000 units (more than 40,000,000 treatment days), with no reports of adverse effects.
Medgadget: What is your background in medical technology and innovation?
Kotak: I am the Executive Vice President of BioElectronics Corporation who is also a Fellow of the Royal College of Anaesthetists and Member of the Royal College of Physicians. Prior to my appointment at BioElectronics, I served as Chief Medical Officer of TraumaTec, a Houston medical device company as well as a consultant to the Boss Group and Blackstone Valley Group, two private equity firms.
I bring a medical perspective having practiced as a specialist in intensive care medicine, anesthesia and trauma in a London teaching hospital, and trained at Oxford University and University of London. I also practiced for four years as a civil lawyer.
