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Brooklyn, NY

Advancing FDA clearance and commercialization of a wearable brain stimulation device for mental health treatment.

• Clinically Proven Technology: Demonstrated effectiveness in reducing depression and anxiety, supported by published trials.
• Regulatory Pathway: Preparing for FDA clearance and CE Mark applications for anxiety and depression treatments.
• Veteran and First Responder Focus: Strategic partnerships to support adoption within the VA and first responder communities.
• Proven Market Fit: 100,000 devices sold under temporary FDA clearance with $40 million in revenue.
• Next-Generation Design: OAK was developed with leading design teams and offers enhanced cognitive and mental health benefits.

OAK is a next-generation wearable device designed to treat mental health conditions such as depression and anxiety through brain stimulation. Developed by Fisher Wallace, OAK builds on 15 years of research and the success of its Version 1.0 device, which sold 100,000 units and generated $40 million in revenue under temporary FDA clearance. OAK’s technology has been modeled by Massachusetts General Hospital and Harvard Medical School, demonstrating engagement with critical brain structures associated with mood, sleep, and cognition. The company is pursuing FDA clearance for anxiety treatment with an anticipated submission by April and plans for future regulatory approvals in both the U.S. and Europe.

The funds raised through this convertible note offering will be used to support OAK’s FDA clearance applications, expand clinical trials, and prepare for commercial release. The company aims to market OAK not only as a medical device but also as a wellness tool that appeals to a broader consumer base interested in cognitive enhancement and mental well-being. Strategic partnerships, including one with BlueIO for venture financing, and advisory support from Dr. David Shulkin, former US Secretary of Veterans Affairs, position Fisher Wallace to scale OAK’s impact, particularly among veterans and first responders. With an established market presence and strong clinical results, OAK is on track for a 2025 launch in the U.S.

Company Info

Fisher Wallace Labs develops the OAK wearable device, designed to treat depression, anxiety, and improve cognitive function.

Fisher Wallace Labs is a company focused on developing wearable devices for mental health and wellness, with a special emphasis on treating depression, anxiety, and cognitive function improvement. Their flagship product, OAK, is a wearable brain stimulation device that has undergone 15 years of research and millions of hours of real-world usage. OAK has been proven to significantly reduce symptoms of depression and anxiety, offering a self-administered, rapid treatment option. This device is designed to be both scalable and appealing, aiming to provide lifelong brain health through consistent use.

OAK has demonstrated clinical success through several trials, including a 255-subject study published in The Journal of Clinical Psychiatry and a separate 220-subject study conducted by the Seattle Police Department. The device has been temporarily FDA-cleared and is currently being used in pilot programs, with plans to expand its reach, particularly for veterans, first responders, and children with mental health concerns. Fisher Wallace Labs is in the process of obtaining full regulatory approval for OAK in the US and Europe in 2025.