The United States has been battling a mental health crisis for a long time. Rates of depression and anxiety were already high, but the COVID-19 pandemic only made matters worse. Isolation, loneliness, the persistent negativity of the news cycle, and a host of other factors caused mental health issues to skyrocket over the last two years.
Fisher Wallace Laboratories manufactures an FDA-cleared wearable medical device, the Fisher Wallace Stimulator, that treats symptoms of anxiety and depression. After obtaining a prescription, patients put on the neurostimulator headband and receive brain stimulation for 20 minutes at a time while watching TV or doing other activities. Many patients reported improvement in just two weeks. We reached out to co-founder, CEO, and Director Kelly Roman to learn why he has personally experienced the technology’s efficacy and what the company is looking for in an exit opportunity.
Note: This interview was conducted over phone and email. It has been lightly edited for clarity and length.
In your own words, how would you describe fisher wallace laboratories?
Fisher Wallace Labs developed a prescription wearable that received FDA clearance to treat depression, anxiety, and insomnia. Our technology electrically stimulates the brain for 20 minutes to produce neurochemicals and modulate brainwave activity and the sympathetic nervous system. The brain itself is an electrical system, so we took an electrical, non-drug approach that works without causing serious side effects. We’ve sold 85,000 version one devices through 14,000 prescribers, and we are in the midst of building version two and applying for FDA approval to treat major depressive disorder. We think version two, which will come out next year, has the potential to significantly disrupt the mental health treatment market.
What inspired you to take the leap and start this company?
My co-founder acquired the technology from the electrical engineers who created it. When I tried the device, it successfully treated my own depression and anxiety symptoms with zero side effects, so I was hooked from that moment onwards. I knew we had a long journey in front of us to validate the technology in clinical trials and design and build a version that would appeal to consumers, but if millions of people could experience the same results I did, I also knew we could build a tremendous business and make a positive societal impact.
Who is on your team and how did you come together?
My co-founder found me through the Harvard Alumni network. We both went to Harvard, but I went two decades after he did. The next thing we did was build a rock-solid medical advisory board and hire a few key consultants to help us navigate the FDA. About a year ago, I brought on Peter Rojas as an advisor. He is head of product at Meta’s new product experimentation unit and had been a partner at Betaworks Ventures. I then hired Eric Fields and Alloy Product Development to help us build version two. Between them, they helped build the Beats headphones, the Microsoft HoloLens, and the first Nest thermostat. A few months ago, after raising several million through equity crowdfunding, we tried venture capital for the first time, and that’s when Simon Webster joined our board. He has tremendous mergers and acquisitions experience. Finally, Jennefer Wang joined us as chief marketing officer this past March, having led strategy at Likeable Media, where she oversaw campaigns for major healthcare and consumer brands.
What is the current fda-approval progress and timeline?
Our technology is currently cleared by the FDA, and we are allowed to maintain that marketing clearance until the FDA renders decisions on our new research, which is targeting full FDA approval to treat depression and new FDA clearance to treat anxiety and/or insomnia. The deadline for us to submit clinical data for FDA approval is December 11, 2022, and we launched a new depression study that will yield results by the end of the summer. We completed the anxiety and insomnia trials last year and submitted them to the FDA and are awaiting their feedback. They may accept the data, or they may ask for more data and give us additional time to get it done. We will not need to redo any studies with our version two device because it delivers the same treatment as version one, just with a much improved industrial design (a fully head-based wearable with no visible wires).
How is fisher wallace laboratories transforming the mental health industry?
We’re better, faster, and cheaper. The majority of our customers either find medication to be inadequate, have completely failed with meds, or are looking to avoid medication. Aside from behavioral therapy, which is expensive and requires a lot of homework, there are very few regulated options to treat depression, anxiety, or insomnia. Ours is affordable without insurance, prescribed via telemedicine, FedExed to the home, and does not cause serious side effects. We even have a 30-day, 100% refund policy – a refund policy for drug therapy and behavioral therapy is unheard of!
What does the competitive landscape look like, and how do you differentiate?
Drug therapy and behavioral therapy are the 800-pound gorillas in our space, and their disadvantages, collectively, are cost, side effects, and lack of patient compliance.
Who is in your customer pipeline?
We have a healthy, scalable, direct-to-patient e-commerce business already, with more than $4 million in sales last year, but this year we’ve started developing our business-to-business channel by partnering with the Seattle Police Department (SPD). This past January, SPD launched a pilot study that provides up to 200 officers with a device for eight weeks, and they are tracking the results as you would in a traditional clinical trial. If the study goes well, SPD will likely buy devices for the rest of the force, and we will start scaling to other police departments. That success will also allow us to scale our solution to corporate and institutional clients in many different sectors over time. If we obtain FDA approval for depression or new clearance for anxiety or insomnia, that will also allow us to work with many insurance providers — whether private, Medicaid, or employer programs.
How do you intend to use the money you raise this round to scale the business?
The money we are currently raising will support engineering completion and production of version two as well as supplement our research initiatives, all of which are already underway.
What do you want potential investors to know about you and/or your company?
Fisher Wallace is a lot more than an idea. We are an operating company that has demonstrated traction and the ability to navigate the complexities of FDA regulation, medical device product development, and clinical research. We are well down the path to becoming a trusted brand in the prescription wearable and mental health space, and I think this is a great time to join us on this incredible journey.
As you think about the business 5-10 years down the road, what do you see exit opportunities looking like? have you set any future goals for the company?
We want to be acquired by a much larger company in the next two years that already manufactures and markets hardware at enormous scale and that can immediately bring supply chain advantages and has a vast customer base. We want one of the big tech companies that wants to become the Pfizer of the prescription hardware category. We are working hard to provide a partner like that with a scalable platform that already has the regulatory approval, clinical research, and industrial design assets in place — things that take years to develop, regardless of the size of the enterprise.
We look forward to seeing where Kelly and his team take the company. Fisher Wallace Laboratories is currently raising on StartEngine.