With more than 50 million surgeries taking place in the U.S. each year, many Americans face a long and painful path to recovery. The healing process is often complicated by pain-reducing treatments (such as Percocet or its generic alternatives) that produce both uncomfortable and dangerous side effects. More importantly, these drugs disrupt the body’s natural healing progress, slowing wound repair and lengthening costly hospital stays.
Various forms of electromagnetic therapy have been used effectively over 50 years as a non-invasive alternative to pharmacological interventions (drugs), but have historically been burdened by unwieldy equipment and an incomplete knowledge of the principles (mechanisms of action) behind the technology.
Ivivi Health Sciences’ proprietary, FDA-cleared (and CE approved) technology now provides an alternative to the currently available pain treatments with its targeted pulse electromagnetic field (tPEMF) technology. The San Francisco-based company has utilized advances in our understanding of cellular biology and biophysics to design, develop and market a highly effective, side effect-“free,” non-invasive anti-inflammatory. Ivivi’s technology is initially targeted at the post-surgical and pain markets.
Ivivi’s technology induces (based on Faraday’s Law) a therapeutic micro-current through damaged tissue through the use of a simple applicator and signal generator. This targeted, a priori designed, micro-current is designed to enhance and accelerate the body’s natural healing processes to help repair injured tissue and to reduce related pain and inflammation. This stands in stark contrast to existing painkillers and other anti-inflammatory drugs, which disrupt the natural healing process in their quest to alleviate pain. Ivivi’s technology has the specific effect of increasing the production of nitric oxide (a central player in the body’s anti-inflammatory and healing biochemical “cascades”) and in turn increasing the production of the required growth factors needed to promote accelerated healing.
The current products (both DME and disposable versions) can be used over clothing and wound dressings. Treatment sessions typically last about 20 minutes two or three times a day. The technology is free of side effects or negative interactions with other treatments; it has now been used on more than 600,000 patients without incident. Recently published data from randomized, placebo-controlled clinical trials found that the company’s proprietary signals effectively reduced pain in patients who were recovering from various forms of surgery as well as in the chronic areas of osteoarthritis and anginal pain. A recent multi-center study found that tPEMF significantly reduced post-operative pain and narcotic use immediately following breast reduction surgery. The double-blind, placebo-controlled, randomized study involved 24 patients who had undergone breast reduction surgery for symptomatic macromastia. tPEMF produced a 57 percent decrease in mean pain scores at one hour following the surgery, and a 300 percent decrease at 5 hours post-op, persisting to 48 hours after the surgery, along with a 2.2-fold reduction in narcotic use compared to the control group. No adverse side effects were reported.
The company’s technology is also currently used in the treatment of chronic wounds (including diabetic ulcers and bedsores), for which it is approved for Medicare/Medicaid reimbursement. The company, which is now privately held, is currently seeking investors and distribution partners.