Offering Circular | Risks Related to this Offering | SEC EDGAR Filings | Signed to Trade Disclosure

Traction

• Over 70,000 patients and 10,000 prescribers in the United States, with over $23.3M in lifetime revenue 

Clear Path to FDA Approval

• Three clinical trials were submitted to the FDA on March 19, 2021 to support new approval and clearance; over-the-counter approval has been obtained in Europe, and Medicaid has approved the device 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 submitted clinical trial results to FDA on March 19, 2021 to obtain new FDA Approval and Clearance, as well as expanded insurance coverage.

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

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.

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 70,000 medical devices through 10,000 licensed healthcare providers in the United States. The company has executed multiple randomized, controlled clinical trials which have been submitted to the FDA.

* Source

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.

(source)

• 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

The CDC Reports Highly Elevated Rates of Mental Health Conditions;

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 clinical trials and are developing a Version 2.0 device with improved industrial design and an app.

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, Fisher Wallace has turned its focus to 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

Obtaining new FDA Approval for one or more indication - depression, anxiety or insomnia - will help establish a new standard of care that can serve millions of patients. 

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.

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