Kingfisher Americas (Albuquerque, New Mexico) reported received FDA clearance of its KFH Energy product used to treat chronic pain associated with post-polio syndrome, fibromyalgia, chronic fatigue syndrome and multiple sclerosis. The clearance is for use for pain treatment at home.
Henk Snyman, CEO of the company's parent firm, Kingfisher Healthcare (Leuven, Belgium), told Biomedical Business & Technology, "It's not a disease-specific approval. "The labeling is broadly for chronic, intractable, post-surgical pain.
Kingfisher says that KFH Energy uses a form of micro-current technology called Bio-Electric Stimulation Therapy (BEST), designed to enhance the body's physiological processes. The system is hand-held and features a touch-screen panel.
"It's very safe — we've not found any side effects, Snyman said. "The threshold to cause damage to skin is 20 times higher than what we can deliver with KFH Energy. It's designed as a stand-alone therapy, but can be complementary to drugs and other therapies prescribed by physicians.
He said most patients studied have a response within a week, while others take longer to feel the effects.
"There's a variation in response rates, but within one month to six weeks, patients know if it's going to work for them or not. Three out of four patients have a response.
Because of its portability, KFH Energy can be used anywhere. Typical treatments recommended are a half-hour to one hour a day, either in the home or in a clinic setting.
After acute pain subsides, patients can use KFH Energy as a maintenance therapy, according to the company. "We studied this and, very consistently, patients tell us they need it once or twice of week as maintenance, Snyman said. "Some patients started the treatment two years ago and then use it for maintenance after two or three months.
"It works with extremely low levels of current, he said. "You can't feel it. It's a box with a lead and electrodes that are applied to skin. Unlike other electrotherapy devices, where you have to deliver higher current, bioelectric stimulation works at the level of the cell.
Snyman explained that KFH Energy works by inhibiting inflammatory cytokines responsible for pain. "If you bump your hand, these cytokines get released locally, cause swelling and pain.
An international 12-week study in 25 polio survivors showed positive and statistically significant effects, including a 34% reduction in pain, 34% reduction in fatigue and a 40% improvement in endurance. One caveat here: The study did not include a control group.
Herb Whitaker, Kingfisher Americas CEO, said, "There is a growing demand among individuals with chronic pain for alternative treatments to improve their condition.
If a patient doesn't choose to purchase the device — at a pricey $5,00l — the company offers a rental program at $100 per month. Snyman said reimbursement is not yet available from insurers but that the company is hoping to win coverage by the end of the year.
Kingfisher now is seeking approval for over-the-counter (OTC) classification in the U.S. Snyman said that the company expects to receive OTC approval "by July or August of this year.
KFH Energy received CE-marking last September.