Medical Device Daily, a part of Thomson Reuters, recently published an article exploring alternatives to drugs for pain-relief and interviewed our very own founder Sherry Fox. You can read the entire article below.
This article originally appeared in Medical Device Daily and was written by Amanda Pedersen.
Health care policy makers, providers, payers and the pharmaceutical industry have been battling the opioid abuse epidemic for years but the problem seems to be getting worse instead of better. Recent statistics from the Centers for Disease Control and Prevention linked prescription opioid (pain killers) abuse to nearly 23,000 deaths in 2013, four times the number of opioid-related deaths in 1999. There has also been a 300 percent increase in prescription opioid sales over that time, according to the CDC.
While the pharmaceutical industry and FDA duke it out over the appropriate development and labeling of new drugs designed to deter abuse, there are some drug-free approaches that employ various forms of energy, including light, to ease pain. One such product is the Lumiwave, a non-laser infrared light energy device that the FDA cleared back in 2005 for the temporary relief of muscle and joint pain. Biocare Systems Inc. (Parker, Colo.), the company that makes Lumiwave, previously sold the device primarily to sports medicine and orthopedic clinicians because of manufacturing costs. But new manufacturing technologies have allowed the company to introduce the product to consumers.
“Initially my cost of goods was about three times what it is right now,” Sherry Fox, who founded Biocare in 1999 with her late husband Joe Pecukonis, told Medical Device Daily. “This is our first product launch, so to speak, nationally.”
Fox said she had a strong interest in keeping the device U.S.-made, which was a more expensive route than having it manufactured outside the U.S., and until now the Lumiwave was produced at boutique manufacturers. Recently the company found a Tennessee-based manufacturer that can mass-produce Lumiwave, bringing the cost down enough to sell it to consumers for $299.
The Lumiwave is designed to release nitric oxide, a key component in healing, while also increasing circulation and decreasing inflammation. The target market for the device is the “active boomer population”, Fox said, who want to stay active despite pain from arthritis, injury or general aging. Still, she said the device has been popular among athletes and that all of the U.S. Olympic training centers have purchased the device.
“We’ve had people who have won Olympic medals say they might not have been able to continue [after an injury] without the device,” Fox said.
Fox said the device uses 200 light-emitting diodes (LEDs), which would ordinarily make it a clinical device priced at roughly $3,000 to $4,000. The consumer market has had inexpensive pain relief devices available, but Fox said most of those products only use 25 LEDs and are not as effective as the Lumiwave.
Another differentiating factor, she said, are temperature controls that prevent the Lumiwave from getting too hot and damaging tissue. The device is also designed to automatically shut off after 20 minutes of use. Fox said there is no real benefit to using the device more than 20 minutes because the body only produces a limited amount of nitric oxide.
While the company is not able to promote the device as an alternative to drugs commonly prescribed for patients with chronic pain because there is no clinical evidence to support such a claim, Fox said she has seen cases where people with arthritis have slowly been able to decrease their dependence on medication by using the Lumiwave twice a day for 20 minutes over a long period of time. The product is available to all age groups from children to elderly.
In September, Avacen Medical (San Diego) introduced its FDA-cleared device, the Avacen 100, for over-the-counter use that is also designed to provide drug-free muscle relaxation and pain relief to the whole body. The Avacen device is about the size of a bread box. To use it, patients stick their hand inside the machine for 20 minutes. In addition to temporary pain relief, some consumers have reported stress reduction and have even dosed off while using the machine, Avacen said.
One key difference between the Lumiwave and the Avacen is that the therapeutic benefits of using the Lumiwave are more localized so patients would have to move it around to different areas of the body depending on where their pain is. Avacen said its device uses just a single point of contact (the hand) to alleviate pain throughout the body.