A device that has been around for nearly 30 years to help treat depression and anxiety without the side effects of medication is finally starting to make headway.
"We acquired the patents [to the brain stimulator] in 2006 and started re-commercializing it a couple years after that," Kelly Roman, co-founder of Fisher Wallace Laboratories, said. "I think what was interesting about the device was that people didn't really use the word 'wearable' until Fitbit."
Roman said that prior to the mainstream arrival of health wearables, the Fisher Wallace Stimulator was still a wearable but understandably mis-categorized.
"Before wearables, it was just harder for the patient to categorize what we're offering” Roman said. “Is this electroshock therapy? It's not. That's something almost like a surgical procedure in which you go under anesthesia."
Roman said the brain stimulator is different from that.
"We're a daily dose of gentle neurostimulation," Roman said.
Roman said there has been much research done on the impact of stimulation frequencies on brain behaviors.
"Everything from Alzheimer's to cognitive enhancement and, in our case, being able to reduce anxiety and improve sleep and reduce depression," Roman said. "We kind of got involved in this technology because consumers were beginning to embrace devices that you put on that could help with your health."
Roman said that the stimulator is not simply monitoring your steps or your heart rate or other biomarkers - it is actively delivering treatment to the brain using an FDA-Cleared frequency package.
"We're using that to improve chemical production, lower cortisol—which is the stress hormone—modulate the default mode work—which is the center brain—and to entrain an alpha wave brain state," Roman said. "We influence brain behavior with the stimulation. This is used on a daily basis. It's very comfortable, it's relaxing. You're having a long-term impact on brain function that's positive."
Roman said the clinical trial of the device for the treatment of depression, which was conducted at Mount Sinai Beth Israel Hospital, yielded a large-effect size that demonstrated active treatment was more effective than placebo.
"What we saw was that in the first week in the placebo group, they're having the placebo effect, but by the second week they're back to baseline," Roman said. "The active group kept getting better and never went back to baseline. So we've shown that this is not just a placebo effect, which is very important."
Roman said they've built up a business, but they're still not a huge company.
"We sold more than 10,000 units last year and we'll sell 15,000 to 20,000 units this year," Roman said. "We've got 9,000 prescribers."
Roman said they're seeing more and more doctors having confidence in the treatment.
"It's extremely low risk and only has about a 1 percent side effect rate compared to an antidepressant that has about 38 percent," Roman said. "That's documented by the NIH. We're not quite as convenient as a pill—you can't swallow it and forget about it."
Roman said you have to wear the device for 20 minutes and use it daily.
"The easy part is you don't get the side effects and you can actually derive other benefits besides anti-depression and sleep, which are enough in and of themselves," Roman said. "A lot of patients experience higher cognitive function, creativity, focus."
Roman said the brain stimulator was technically on the market before cell phones even existed.
"The nomenclature is catching up to the technology," Roman said. "It's a very effective technology that was overshadowed by the drug industry."
Roman said antidepressants are the go-tos for doctors and his company is trying to change that.
"We work well with drugs, so if you're already on an antidepressant and it's not working so great you can try coupling it with the device," Roman said. "You can get on a lower dose of the antidepressant or even off of it, in consultation with your doctor."
Roman said the device is an option for people who don't want to take medication or who have tried medication and either didn't like the side effects or found it to be ineffective or only temporarily effective.
"It makes more sense for us to be a first-line treatment because we're so low-risk," Roman said. "At $399, [it] is pretty affordable for an out-of-pocket healthcare expense when you consider the cost of medication every month plus the doctor's visits to monitor those drugs. It's a lot less expensive in the long run."