This is an exclusive BHB+ story
Behavioral health providers have been slow to adopt Transcranial Magnetic Stimulation (TMS) services because of the devices’ costs and bulky size. However, newer versions have been designed to be smaller and more lightweight, making the technology increasingly accessible to consumers with the rise of in-home neuromodulation.
In 2008, TMS therapy landed FDA clearance for treatment-resistant depression. Over the last 17 years, interest in this treatment modality by clinicians and patients has accelerated innovation within the space beyond practice walls.
Neurolief, the company behind a new milestone in the TMS-space: a wearable, non-invasive brain stimulation device for at-home and in-clinic treatments, recently published positive results from a study of the device’s potential for treating depression. Currently, it is only FDA-approved for at-home migraine treatment, but the company is actively pursuing regulatory approval for behavioral health conditions.
“Our intent is as fast as possible to get [this device] to that primary care level,” Steve Beller, chief commercial officer, Neurolief, told Behavioral Health Business. “That way those doctors would actually have access to this, know about it, be educated about it, and be able to prescribe it. … We have to first get the FDA’s approval, and then we can begin to work on getting insurance coverage and reimbursement. We won’t have that at launch, but we are already in discussions with several of the large commercial payers about what we need to do so that they would actually cover and provide reimbursement for this.”
In August, BrainsWay, one of the leading companies behind TMS technologies in the behavioral health space, made a $5 million convertible loan investment in Neurolief because of its novel at-home technology.
At first, Neurolief’s solution will be available as a cash-pay alternative for patients or available through integrated care delivery networks like Kaiser Permanente or the Department of Veterans Affairs, Beller said.
But with recent and increasing recognition of patient outcomes from TMS by more payers, Beller expects accessibility both for TMS and future in-home neuromodulation solutions to grow too. Just last month, New York State Medicaid coverage expanded to include coverage for TMS therapy.
Other players are aiming to achieve a similar status, like Flow Neuroscience, which is actively pursuing FDA clearance for its own at-home brain stimulation devices for treatment-resistant depression and major depressive disorder.
The company is seeking to become the first non-drug prescription device that clinicians in the U.S. can prescribe for depression treatment. Results from its phase 2 trial found that home-based solutions could “be a potential first-line treatment for MDD as it demonstrates efficacy, acceptability and safety,” in time. The solution is already approved in the U.K.
As these new in-home devices begin to receive full FDA clearance, Dr. Richard Bermudes, chief medical officer of BrainsWay, thinks that additional evidence from a study “showing that home-based TMS can sustain or extend the therapeutic benefits achieved during in-clinic sessions would further support the case for reimbursement.”
Meeting patients where they’re at
A persistent barrier to the widespread adoption of traditional TMS therapy is that it typically requires a patient to visit a physical clinic location multiple times a week for over the course of six weeks or more – which isn’t always accessible or easy to fit into a schedule.
On top of that, many patients with treatment-resistant depression or major depressive disorder do not even seek help to begin with, so the extra layer of having to come in-person for treatment can build more of a wall to TMS treatment access.
BrainsWay recently received FDA clearance for “deep TMS,” an accelerated approach to TMS that reduces the in-clinic barrier for patients. Instead of a traditional treatment timeline, the schedule is reduced to five sessions per day for six days over two weeks, followed by two sessions per day once a week for a month.
Both Bermudes and Beller agree that the rise of in-home neuromodulation devices could complement the work done during an in-clinic TMS session as a hybrid-type approach or become a more accessible alternative for patients who do not want to take antidepressants.
“Most patients are not treated by psychiatrists for depression, it’s primary care doctors,” Beller said. “These are the first-line clinicians who are seeing patients who present with depression, and instead of referring them to a psychiatrist, they’re just trying antidepressant trials on them. Access is the primary issue for these patients. They either never find out about TMS or something else, or if they do get referred to a TMS clinic, they can’t comply with the treatment protocol, because for TMS, you have to go into the office every day for six weeks, and that’s just hard to do.”
For patients who feel like they’ve tried every antidepressant option in the Rolodex, an at-home solution, once it’s approved, can also fit better into their lifestyle, Beller explained. The wearable device Neurolief is developing, called the “Proliv Rx,” allows for a free range of movement and activity while in use, from lying down to gardening.
What’s next for in-home brain stimulation modalities
While the use-case appears to be a way to lower non-drug prescription alternatives for the treatment of depression and other mental health conditions, these technologies are still not on the market yet and several considerations need to be made, according to Dr. Geoffrey Grammer, chief medical officer of Neuronetics the parent company of NeuroStar.
Neuronetics is the manufacturer of NeuroStar, a brand of TMS therapy devices.
“I think we’ve got to be careful that at-home devices don’t accidentally shift patients back into the shadows for care, but instead augment the existing medicalization of mental health care within this country,” Grammer told BHB. “With that in mind, I think these at-home devices come with some convenience and that you don’t have to go into the center every day, but there’s also a cost.”
The price, he said, is really around the precision of these types of treatments. The field has worked for years to refine aspects of the traditional magnetic-based therapy modality, such as determining the best placement of sensors and coils for the most accurate treatment. It’s a modality that clinicians must be specifically trained in to offer and administer it effectively. At-home neuromodulation and similar devices give up some of that specificity for convenience, Grammar explained.
“Rather than at home TMS replacing in-clinic care, I think what we’ll see is more augmentation of in-clinic care,” Grammar said. “That could be everything from people who otherwise wouldn’t do TMS because they live two hours away from the nearest center, or people who have gotten TMS but need some form of maintenance at home. … I see it as complementary to [TMS] with oversight of that treatment, rather than a replacement for.”
Remote monitoring options by physicians are part of what Neurolief is working on for its in-home neuromodulation device via a downloadable app, to understand and control what adjustments may need to be made for the patient, Beller said. This option is another departure from the run-of-the-mill antidepressant prescribing, with little check-ins or follow-ups on how patients respond.
“Instead of having to commit to an antidepressant trial path, that would be our first goal, so that they then could facilitate getting these patients appropriate care,” Beller said.
While it has yet to come to fruition, in the next few years, the option for remote, in-home monitoring may also improve outcomes, Bermudes explained.
“In-home TMS or remote neuromodulation could expand access for patients with mild to moderate depression, potentially preventing progression to more severe, treatment-resistant forms,” Bermudes said. “Hybrid models, combining in-clinic initiation with at-home follow-up, may be a practical bridge to broader access while maintaining safety and efficacy.”
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