A Superdevice for Mental Health
The result of 17 years of clinical research and product development, millions of hours of real-world testing, and a groundbreaking collaboration with the team behind Beats and Nest, OAK is the first prescription brain stimulation device designed for population-scale. We anticipate initial FDA clearance for anxiety treatment in Q3 2026 and are advancing towards insomnia, depression, and human performance indications in 2027. Our tech is currently being pilot tested in the U.S. Department of Veterans Affairs.
Join OAK Waiting List
Our first manufacturing run is expected to be limited to 10,000 devices, with thousands already reserved by our customers and investors. Sign up for early access to purchase OAK one week before its public launch.
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Optimizing Brain Function
In 2025, researchers at Harvard Medical School and Massachusetts General Hospital modeled the strength of our device's neurostimulation in the brain, demonstrating that it significantly engages structures that govern to mood, sleep, autonomic function, and cognitive resilience. Clinical studies enrolling nearly 2000 participants in total demonstrate safety, comfort, and rapid effectiveness in treating anxiety, depression, and insomnia, as well as bipolar II depression and symptoms of Parkinson's.
Our recently submitted FDA clearance application for the treatment of anxiety includes a real-world study of 164 first responders, conducted in collaboration with the Seattle Police Department, Washington State University, and other first responder organizations. The study showed rapid anxiety symptom reduction that continued to improve over the eight-week study period.
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Proof-of-Concept
As the FDA undertook a multi-year process of determining how our category would be regulated, we were able to distribute our proof-of-concept technology to tens of thousands of patients, through thousands of prescribers. This enabled us to refine our technology and usage protocol with valuable real-world user feedback in a way that would be impossible to replicate today. The new FDA regulation elevates the credibility of the category by requiring clinical trial evidence to support each intended use. We are now awaiting FDA’s decision on our first application submitted under the new regulation.
Our amazing community of early adopters has demonstrated belief in the potential of our next-generation technology by collectively investing more than $11 million through our equity crowdfunding campaigns.
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Leadership
Kelly Roman
Co-Founder, CEO, Director
The son of a US Army veteran, Kelly graduated from Harvard College and has helped pioneer the wearable brain stimulation category since 2009. He is founder-obsessed with clinical research, product development, regulatory affairs, manufacturing, patient advocacy, and visual storytelling.
On Substack: An Affordable Mass of Cognitive Density
Chip Fisher
Co-Founder, Chairman
Chip originally co-founded Fisher Wallace Labs with the late Dr. Martin Wallace. After Dr. Wallace’s passing shortly following the company’s formation, Chip met co-founder Kelly Roman through Harvard’s alumni network, and together they proceeded to build the company. Chip was the company's sole angel investor and proceeded to develop its broad network of researchers, prescribers, and advisors. The son of radio pioneer Avery Fisher, Chip continues his father’s philanthropic tradition and serves on the Board of the Juilliard Artist Program.
Advisors
Maurizio Fava, MD
Advisor
Chair, Department of Psychiatry, Mass General BrighamPsychiatrist-in-Chief, Massachusetts General HospitalSlater Family Professor of Psychiatry, Harvard Medical School
David Shulkin, MD
Advisor
Ninth Secretary, U.S. Department of Veterans AffairsFormer VA Under Secretary for HealthFormer Chief Executive, Beth Israel Medical Center and Morristown Medical Center
Joan Camprodon-Gimenez, MD, PhD, MPH
Advisor
Chief, Division of Neuropsychiatry and Neuromodulation, Massachusetts General HospitalDirector, MGH TMS Clinical ServiceAssociate Professor of Psychiatry and Neurology, Harvard Medical School