On a mission to launch an FDA Approved wearable to treat depression

*OAK (Version 2) is currently under development and not yet available on the market.

Fisher Wallace has developed wearable brain stimulation technology that electrically stimulates the brain to treat depression, anxiety and insomnia without causing serious side effects. The company’s proof-of-concept device, the Fisher Wallace Stimulator®, has been cleared by the FDA and purchased by over 100,000 patients.

In 2022, the company completed a pivotal clinical trial and submitted it to the FDA to obtain FDA Approval for the treatment of Major Depressive Disorder. The rapidity of treatment and the Week 4 responder rate achieved in the trial is comparable to the drug esketamine and caused no serious adverse events. The company expects to receive an approval or denial decision from the FDA by Q3 2023. Approval will support the company’s efforts to scale the business and obtain insurance reimbursement for its products.

The company also launched a first responder pilot program in collaboration with the Seattle Police Department and Washington State University in 2022 to improve the mental health and wellness of uniformed officers and 911 responders. Other departments have since joined the program, and enrollment remains open. The results of this program are intended to support the company’s efforts to scale its solution to first responder communities nationwide.

Since the outbreak of COVID-19, professional sports journalism has focused on the mental health crisis affecting professional athletes, and in October 2022, the company engaged sports agent David Sloane to assist in increasing adoption of the company’s technology by pro sports teams, with a focus on Major League Baseball and the NFL.

The company is nearing completion of its Version 2.0 device, called OAK, in collaboration with Alloy Product Development and Eric Fields, the engineers and designers behind Beats, Nest and the Microsoft Hololens. OAK will deliver the same treatment as the company’s Version 1.0 device and will inherit any new regulatory approvals or clearances. 

With world-class design and scientific validation, OAK is intended to appeal to tens of millions of people seeking a better way to improve mental health and wellness.

48 million Americans are prescribed antidepressant medication

Source: IQVIA

Depression alone afflicts nearly one in three Americans (source), and at least 50 million Americans suffer from a sleep disorder (source). 

We believe delayed treatment effects, side effects, modest efficacy, and high administrative costs make drug therapy and behavioral therapy insufficient solutions

Antidepressant medication can take as long as 12 weeks to be effective (source). Medication also causes a wide range of side effects, sometimes serious, and even in generic form is expensive when the cost of doctor visits is included. The average cost of seeing a therapist is $100 - $200 per session (source) and as many as half of all patients fail to complete the “homework” associated with cognitive behavioral therapy that’s needed to experience results (source). While these standards of care help millions of patients every year, millions more are in need of safe, effective alternatives or adjuncts.

Our clinical trial evidence demonstrates that our technology rapidly treats depression, as well as anxiety and insomnia (often co-occuring symptoms with depression), without causing serious side effects. The device may be used safely as a standalone treatment or in conjunction with medication and/or psychotherapy. Additionally, more than 40.1% of surveyed Fisher Wallace customers report improvements in cognitive performance (focus, concentration, memory) in addition to symptom reduction. 77.4% of surveyed customers stated an intention to use their Fisher Wallace device for the rest of their lives to maintain mental health and cognitive performance.

*OAK (Version 2) is currently under development and not yet available on the market.

Proven product-market fit and scalability

Leveraging a vertically integrated e-commerce model with an integrated telemedicine prescription process, Fisher Wallace has succeeded in generating over $40 million in lifetime revenue from its direct-to-patient sales channel. Over 14,000 providers have prescribed the Fisher Wallace Stimulator®. 

The company’s ongoing clinical research is designed to both obtain new FDA Approval and Clearances, as well as enable the company to expand insurance coverage. Medicaid in Maine (MaineCare) became the first state Medicaid program to fully cover the purchase of the Fisher Wallace device. 

*OAK (Version 2) is currently under development and not yet available on the market.

Join us as we disrupt the mental health industry

*OAK (Version 2) is currently under development and not yet available on the market.

Our team is uniquely prepared to bring a refreshing vision of mental healthcare to life. We believe we possess the technology, skills, and timing required to successfully build and scale our solution. Become a shareholder in Fisher Wallace as we disrupt the status quo to better serve tens of millions of patients. Invest $1,500+ and receive a coupon code at the conclusion of the campaign to obtain our Version 2.0 device for free!

AN OFFERING STATEMENT REGARDING THIS OFFERING HAS BEEN FILED WITH THE SEC. THE SEC HAS QUALIFIED THAT OFFERING STATEMENT, WHICH ONLY MEANS THAT THE COMPANY MAY MAKE SALES OF THE SECURITIES DESCRIBED BY THE OFFERING STATEMENT. IT DOES NOT MEAN THAT THE SEC HAS APPROVED, PASSED UPON THE MERITS OR PASSED UPON THE ACCURACY OR COMPLETENESS OF THE INFORMATION IN THE OFFERING STATEMENT.

THE OFFERING CIRCULAR THAT IS PART OF THAT OFFERING STATEMENT CAN BE FOUND HERE

CROWDCHECK VERIFIED REPORT CAN BE FOUND HERE.

THE OFFERING MATERIALS MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY. THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT. WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, WHICH CONSTITUTE FORWARD LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS. INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE. THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO REVISE OR UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT EVENTS OR CIRCUMSTANCES AFTER SUCH DATE OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.