Q&A with Kelly Roman of Fisher Wallace Laboratories

A million Americans checked into an emergency department last year because of suicidal ideation - 114 people every hour - and 46,000 people commited suicide - 5 people every hour. Depression is a crisis that medication and behavioral therapy alone are not solving. Anxiety and insomnia have enormous prevalence and impact on people's lives as well: 60% of adults will experience symptoms of depression, anxiety or insomnia this year. Treatment as most people know it is too often insufficient, slow-acting, expensive, and/or comes with side effects. Fisher Wallace has spent more than a decade developing technology that can improve outcomes on a massive scale.

We were able to commercialize our proof-of-concept wearable to treat depression, anxiety and insomnia under temporary FDA clearance, which was granted under a "grandfathered 510(k)" that has since expired. That allowed us to treat 100,000 patients through 14,000 prescribers and gain valuable clinical and market insights. We are now on a path to obtaining permanent FDA approval and CE Marks to commercialize our Version 2.0 technology, called OAK, and we expect to launch OAK in the second half of next year.

We've demonstrated that our medical technology rapidly treats depression without causing serious side effects - we accomplished that with our most recent randomized, controlled trial for the acute treatment of major depression, which enrolled 255 subjects. Importantly, we are not going to rely on insurance reimbursement for our business model, which often handicaps a product's ability to scale. Insurance can supplement our business, especially Medicaid which could make our product available to those who can't afford $400 - $600 out-of-pocket. But $400 - $600 is a reasonable out-of-pocket expense for many people who want to solve their mental health challenges. By comparison, a single talk therapy session costs upwards of $120. We've also focused on working with world-class industrial designers and engineers to make our Version 2.0 product desirable, both clinically and aesthetically. OAK is a new, beautiful form factor that's not been associated with clinical-grade brain stimulation before. Lastly, we are working to serve an enormous market - we can have a very successful business if a tiny percentage of the market adopts our technology. Our goal is to serve the majority of the market.