Offering Circular | Risks Related to this Offering | SEC EDGAR Filings

Traction

• Over 60,000 patients and 10,000 prescribers in the United States, with over $23.3M in lifetime revenue 

Clear Path to FDA Approval

• Three clinical trials underway to support the approval process, and recently granted over-the-counter approval in Europe and Medicaid approval in Maine (MaineCare)

Previous Crowdfunding Success

• Raised over $1M in an oversubscribed Reg CF raise from over 1400+ investors

• The FDA defined our approval path on December 19, 2019, requiring Fisher Wallace to conduct three clinical trials (one each for depression, anxiety and insomnia).

• Fisher Wallace launched three clinical trials in July, 2020 in collaboration with three of the nation’s leading experts on sleep, depression and anxiety. These studies will be used to obtain FDA Approval and insurance coverage over the next 18 months.

• Fisher Wallace successfully migrated its manufacturing to a high-volume facility that has reduced its cost of goods sold (COGS) by 60%.

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Antidepressants, anti-anxiety and sleep medications all cause a high rate of side effects, some serious, and even in generic form are expensive when doctor visit costs are included. Behavioral therapy (psychotherapy or CBT) does not cause serious side effects but is expensive and requires a very high level of patient engagement. Neither drug therapy nor behavioral therapy have demonstrated high rates of efficacy.

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The Fisher Wallace Stimulator® comfortably stimulates the brain to produce serotonin and modulate brainwave activity. The device has demonstrated a high effectiveness rate and less than a 1% side effect rate (temporary headache or dizziness) in clinical practice. In a depression study conducted at Mount Sinai Beth Israel Hospital in 2015, patients who used a placebo device returned to baseline while patients who used an active (fully functioning) device experienced durable depression symptom reduction.

Fisher Wallace has demonstrated product-market fit by selling over 60,000 medical devices through 10,000 licensed healthcare providers in the United States. The company has recently launched three randomized, controlled clinical trials to obtain FDA Approval for the treatment of depression, anxiety and insomnia.

Patients may obtain a telemedicine prescription for the device which is then shipped directly to their home. This has been an effective model for treating mental health during the COVID-19 pandemic - and for patients in general who cannot easily access mental health treatment or are resistant to drug or behavioral therapy.

Patients use the device for 20 minutes, one or twice a day, and typically experience symptom reduction within the first week of use. A 392-subject study conducted at a Phoenix House drug and alcohol rehabilitation facility demonstrated that the device increased rehab retention by 50%.

These testimonials may not be representative of the experience of other customers.  These testimonials are no guarantee of future performance or success.

• Mental Health is the #1 healthcare cost in the US, greater than cancer, diabetes or heart disease - half of all costs are spent treating depression and anxiety (source)

• 1 in 4 Americans also develop insomnia each year

• Spending is expected to continue growing, especially as demand grows as a result of the pandemic

Our affordable medical device is easy to use, causes minimal side effects, may be prescribed remotely and shipped directly to a patient’s home. This offers significant clinical and economic advantages over medication and behavioral therapy while also working well in conjunction with these standards of care (many providers prescribe the Fisher Wallace device in combination with medication and behavioral therapy).

Our goal is to create a new standard of care for the treatment of depression, anxiety and insomnia that is broadly covered by insurance. This is why we have invested in three clinical trials that will yield data for the FDA before the end of 2020.

We currently leverage online advertising and email marketing to drive patients and doctors to our e-commerce website where we educate them about our technology. Upon receiving a prescription, we ship the device directly to the patient, who typically purchases the device out-of-pocket. We offer a 100% free return and full refund policy. We are now focusing on obtaining FDA Approval and broad insurance coverage for our technology - to ultimately make our device free to patients and allow us to scale the business more effectively.

Following the completion of our clinical trials, we will focus on commercializing a Version 2.0 device that will feature improved industrial design, data analytics and digital health services relevant to patients, providers and payers. Our goal is to create a true mental health hardware platform that seamlessly integrates into the rapidly evolving digital health ecosystem.

*This is a computer rendering of a product currently in development

Co-Founder and CEO Kelly Roman has helped pioneer the field of wearable neuromodulation and is an expert in product development, regulatory affairs, healthcare marketing and clinical trial strategy. Co-Founder Charles “Chip” Fisher grew up in the electronics business (his father founded Fisher Radio, later renamed Fisher Electronics) and began his career at IBM before acquiring the original patents to the Fisher Wallace device. The company’s medical advisory board is comprised of leaders in the fields of psychiatry, opioid addiction treatment and sleep medicine. Now, they’ve teamed up to disrupt the mental health industry with cutting-edge technology. 

Kelly Roman (left) and Chip Fisher (right) flank Medal of Honor recipient SFC Petry

There is alway risk with any clinical trial that the desired result will not be achieved, but the fact that our technology’s safety and effectiveness has already been validated by over 60,000 patients and 10,000 providers (and by the studies we’ve performed to date) gives us high confidence in successful outcomes. Obtaining FDA Approval for even one indication - depression, anxiety or insomnia - will be transformational for our business. Obtaining FDA approval for all three indications will position Fisher Wallace as a leading hardware platform in the mental health industry.

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.

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.