We have developed a wearable technology submitted for FDA approval for the treatment of Major Depressive Disorder
InvestDepression (MDD) is at scale
Building On Our Momentum
Our Version 1.0
Marketed under temporary FDA-Clearance to treat depression, anxiety and insomnia. We recently submitted the results of our pivotal depression trial to obtain FDA approval.
100K
Version 1.0 Units Sold
14K
Prescribers
"Easy to use, affordable, and helped me sleep better. Wife says I’m easier to get along with now."
- Mike, Real Patient
*Individual Results May Vary
"Gone is the everpresent debilitating anxiety that was preventing me from enjoying life."
- Gail, Real Patient
*Individual Results May Vary
"I turned to the Fisher Wallace Stimulator after exhausting every antidepressant I could be prescribed…I would recommend it to anyone suffering from severe depression."
- Camille, Real Patient
*Individual Results May Vary
Community Updates
Our Pivotal Depression Trial for FDA Approval
Submitted to the FDA on December 9th, 2022
Triple-blind, randomized, controlled trial of 255 subjects with moderate to severe Major Depressive Disorder at baseline.
Results- FAST ACTING
- HIGH ADHERENCE
- HIGH RESPONDER RATE
- SAFE
Conclusion: Potential benefit significantly outweighs potential risk. Our technology is validated as a fast acting, highly effective, safe, self-administered treatment for MDD.
The combination of novel FDA approval and world-class Version 2.0 industrial design intended to deliver smartphone-level ubiquity
InvestIntroducing OAK. The Next Generation Mass Market Wearable for the Treatment of MDD.
Engineering Completion in Q3 2023
Medicine
You Can Wear
Treatment
You Can Feel
Freedom, Unboxed
Evidence-based treatment in a choice of seven colors
Rewiring the Standard of Care for Mental Health
OAK, Connected
Track symptoms, cognitive performance, and engage in talk therapy via secure web app with SMS driven engagement
Longitudinal data and new indication signals
Zero cost of marketing to onboard hardware customers
We are preparing to build and test a first iteration app with current customers by Q4 2023
- Symptom Tracker
- Cognitive Performance
- Talk Therapy
Depression is only the beginning
We intend to launch two new pivotal trials in 2023 to obtain FDA indications in 2024 for Generalized Anxiety Disorder and Sleep Maintenance Insomnia
- Our prior research indicates similar rapidity and responder rate to MDD treatment
- Our research partners are ready to launch the trials (use of funds)
- Depression, anxiety and insomnia affect more than half of the US population
Kelly Roman
CO-FOUNDER, CEO, DIRECTOR
Kelly has led Fisher Wallace since 2009. An expert in medical device product development, regulatory affairs, marketing and clinical trial strategy with previous experience in the media and SaaS industries.
With your help we will rewire the standard of care
Obtain a Free Device with a $1500+ Investment
Receive the OAK device when it's released as a perk for a $1500+ investment. Investing in Fisher Wallace Labs throughStartEngine, one of the leading SEC-regulated equity crowdfunding platforms, is easy. First, create an investment account at startengine.com/offering/fisherwallace after clicking the Invest Now button on the page. Choose the amount you wish to invest, and your payment method.