INVEST IN FISHER WALLACE TODAY!

Prescription Wearables For Mental Health

Fisher Wallace Labs makes wearable brain stimulation technology that is cleared by the FDA to treat depression, anxiety, and insomnia. The company is pursuing FDA Approval for the treatment of Major Depressive Disorder and is building a Version 2.0 device, called OAK, in collaboration with the engineers and designers behind Beats, Nest, and the Microsoft Hololens.

This Reg CF offering is made available through StartEngine Capital, LLC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
Fisher Wallace

$740,645.94 Raised

REASONS TO INVEST

Reasons Icon

Recently completed and obtained strong results from a pivotal clinical trial to apply for FDA Approval for the treatment of Major Depressive Disorder.

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The Seattle, Salt Lake City, and Nashville Police Departments are using the company’s technology to improve employee mental health and wellness.

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You may obtain the company's Version 1 or Version 2 device for free with an investment of $1500+ in this campaign.


Since Our Last Raise...



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

Overview


Prescription wearable technology for depression, anxiety, and insomnia




Fisher Wallace has developed a wearable brain stimulation device 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 early 2022, the company launched a pivotal clinical trial in order to obtain FDA Approval for the treatment of Major Depressive Disorder. This study was completed in late October and a preliminary analysis of results by the company’s biostatistics firm indicates that active treatment was superior to placebo, and that there were no reports of serious adverse events. A final, validated analysis and report will be submitted to the FDA by the December 11, 2022 submission deadline to support FDA Approval. 


The company also launched a first responder pilot program in collaboration with the Seattle Police Department and Washington State University in early 2022 to improve the mental health and wellness of uniformed officers and 911 responders. The Salt Lake City and Nashville Police Departments have since joined the program, and enrollment remains open for at least the next few months. The results of this program will support the company’s efforts to scale its solution to first responder communities nationwide.


Since the outbreak of COVID-19, more attention has also been paid by the media to the mental health crisis facing professional sports. In October 2022, the company engaged sports agent David Sloane to assist in increasing adoption of the company’s technology by 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 its regulatory approvals and 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.

thE Market


The US spends over $225 billion a year on mental health treatment

Source: NAMI



Depression and anxiety affect one in three Americans (source and source), and at least 50 million Americans suffer from a sleep disorder (source). Recent data shows that the pandemic accelerated antidepressant use, with 23% more Americans taking an antidepressant in the third quarter of 2020-2021 versus the same quarter in 2015-2016. (source)

The problem


Side effects, modest efficacy, and high cost make drug therapy and behavioral therapy insufficient solutions


Medication for depression, anxiety and insomnia 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.


the solution


Rapid treatment with minimal side effects

According to our research, brain stimulation technology is gaining acceptance in the mental health industry. In clinical trials conducted with the company’s device, the majority of patients experienced symptom reduction within two weeks of daily 20-minute treatment sessions. The device does not cause serious side effects - temporary headache and dizziness are reported by less than 1% of device users. The device may be used safely as a standalone treatment or in conjunction with medication and/or psychotherapy. Additionally, more than 40% of Fisher Wallace customers report improvements in cognitive performance in addition to symptom reduction.


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

our traction


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 $30 million in lifetime revenue from its direct-to-patient sales channel. Over 14,000 providers have prescribed the Fisher Wallace Stimulator®. In January 2022, Fisher Wallace launched its first B2B channel through a first responder pilot program in collaboration with the Seattle Police Department and Washington State University. The Nashville and Salt Lake City Police Departments have since joined the program.


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.

WHY INVEST


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 1.0 device or Version 2.0 device for free!

ABOUT

HEADQUARTERS

630 Flushing Avenue, Suite #104
Brooklyn, NY 11206
VALUATION

$81.57M
PREVIOUSLY CROWDFUNDED

$7M

Fisher Wallace Labs makes wearable brain stimulation technology that is cleared by the FDA to treat depression, anxiety, and insomnia. The company is pursuing FDA Approval for the treatment of Major Depressive Disorder and is building a Version 2.0 device, called OAK, in collaboration with the engineers and designers behind Beats, Nest, and the Microsoft Hololens.

TEAM

Kelly Roman

Kelly Roman

Co-Founder, CEO, and Director

For more than a decade, Kelly Roman has helped pioneer the prescription wearable category and has expertise in product development, regulatory affairs, healthcare marketing and clinical trial strategy. Prior to co-founding Fisher Wallace, Kelly graduated from Harvard and served as an award-winning executive in the digital advertising and SaaS industries. He recently served on the boards of two charter high schools in New York City.

Charles "Chip" Fisher

Charles "Chip" Fisher

Co-Founder & Chairman & Director

Charles “Chip” Fisher grew up in the electronics business - his father, Avery Fisher, founded Fisher Radio (later renamed Fisher Electronics). After graduating from Harvard and serving as a sales executive at IBM, Chip acquired the original intellectual property to the Fisher Wallace Stimulator and is the company’s CFO and largest shareholder - and a recent TEDx contributor.

Simon Webster

Simon Webster

Board Member

Simon is CEO of SHUFL Capital, the venture capital firm that recently invested in Fisher Wallace Laboratories. Simon's early career was spent in the UK financial services sector leading business change, delivering technology transformations and supporting M&A transactions. He led CPA Global on its 20 year journey from a £50m business to its recent public market entry at a value of £6.5bn. Simon has been investing in and working with founders of growth businesses in the SHUFL sectors since 2010.

Peter Rojas

Peter Rojas

Advisor

Peter is currently Head of Product, NPE, at Meta, where he incubates the company's new and experimental products. Previously, Peter was a Partner at Betaworks Ventures, which invested in Giphy (sold to Facebook) among other startups, and co-founded the popular tech blogs Engadget and Gizmodo.

TERMS

Fisher Wallace
Overview
PRICE PER SHARE
$8.81
DEADLINE
Feb 21, 2023
VALUATION
$81.57M
AMOUNT RAISED
$740,645.94
Breakdown
MIN INVESTMENT
$493.36
MAX INVESTMENT
$123,991.94
MIN NUMBER OF SHARES OFFERED
1,135
OFFERING TYPE
Equity
ASSET TYPE
COMMON
SHARES OFFERED
Class B Non-Voting Common Stock
MAX NUMBER OF SHARES OFFERED
209,393

Maximum Number of Shares Offered subject to adjustment for bonus shares


Company

:

Fisher Wallace Laboratories Inc.

Corporate Address

:

630 Flushing Avenue, Suite #104, Brooklyn, NY 11206

Offering Minimum

:

$9,999.35

Offering Maximum

:

$1,844,761.14

Minimum Investment Amount

(per investor)

:

$493.36











Terms


Offering Type

:

Equity

Security Name

:

Class B Non-Voting Common Stock

Minimum Number of Shares Offered

:

1,135

Maximum Number of Shares Offered

:

209,394

Price per Share

:

$8.81

Pre-Money Valuation

:

$81,567,587.63











*Maximum number of shares offered subject to adjustment for bonus shares. See Bonus info below.

Investment Incentives and Bonuses*

Loyalty Bonus | 5% Bonus Shares

As you have previously invested in Fisher Wallace, you are eligible for additional bonus shares.

Time-Based:

Super Early Bird Bonus

Invest within the first week and receive 10% bonus shares.

Early Bird Bonus

Invest within the first two weeks and receive 5% bonus shares.

Amount-Based:

$1,500+ | Tier 1

Invest $1,500 and receive 2% bonus shares + a free device. 

$5,000+ | Tier 2

Invest $5,000 and receive 5% bonus shares + a free device.

$10,000+ | Tier 3

Invest $10,000 and receive 10% bonus shares + a free device.

$25,000+ | Tier 4

Invest $25,000 and receive 15% bonus shares + a free device.

*All perks occur when the offering is completed.

The 10% StartEngine Owners' Bonus:

Fisher Wallace Laboratories Inc. will offer 10% additional bonus shares for all investments that are committed by investors that are eligible for the StartEngine Crowdfunding Inc. OWNer's bonus.

This means eligible StartEngine shareholders will receive a 10% bonus for any shares they purchase in this offering. For example, if you buy 100 shares of Class B Non-Voting Common Stock at $8.81 / share, you will receive 110 shares Class B Non-Voting Common Stock, meaning you'll own 110 shares for $881. Fractional shares will not be distributed and share bonuses will be determined by rounding down to the nearest whole share.

This 10% Bonus is only valid during the investor's eligibility period. Investors eligible for this bonus will also have priority if they are on a waitlist to invest and the company surpasses its maximum funding goal. They will have the first opportunity to invest should room in the offering become available if prior investments are canceled or fail.

Investors will receive the highest single bonus they are eligible for among the bonuses based on the amount invested and time of offering elapsed (if any). Eligible investors will also receive the Owner’s Bonus and the Loyalty Bonus in addition to the aforementioned bonus.

*Investors will only receive a single bonus, which will be the highest bonus rate they are eligible for.

Irregular Use of Proceeds

The Company will not incur any irregular use of proceeds.

NEW UPDATES

01.30.23

DESIGNED FOR THOSE WHO NEED IT MOST

OAK is designed for everyone, including those who need it most

Gen Z has the highest rate of depression but uses antidepressant medication less frequently than older generations.

Perks for Investors

Our equity crowdfunding investors may obtain OAK (or our Version 1.0 device) for free with a $1500+ investment.

Our campaign closes in three weeks. Thank you for your consideration and feel free to leave a comment or question on our campaign page. 

We are proud to be a patient-owned healthcare company.

ALL UPDATES

01.30.23

DESIGNED FOR THOSE WHO NEED IT MOST

OAK is designed for everyone, including those who need it most

Gen Z has the highest rate of depression but uses antidepressant medication less frequently than older generations.

Perks for Investors

Our equity crowdfunding investors may obtain OAK (or our Version 1.0 device) for free with a $1500+ investment.

Our campaign closes in three weeks. Thank you for your consideration and feel free to leave a comment or question on our campaign page. 

We are proud to be a patient-owned healthcare company.

01.25.23

WE MADE THE LIST

We are pleased to be listed in Vator's "Startups measuring the brain that you need to know" article published this week.

Only two other startups on the list are building products for depression treatment, and we are far more advanced with our pivotal depression research already submitted to FDA for approval.

OUR CAMPAIGN ENDS SOON 

INVEST $1500+ to obtain a free device.

01.23.23

WE OPERATE WHERE BIG TECH DOES NOT

"Big Tech has largely avoided the medical device industry because of the regulatory barriers to marketing and manufacturing - this has allowed us to be a first-mover in the prescription wearable category, and provides us an opportunity to cement leadership for many years to come."

- Kelly Roman, Co-Founder and CEO, Fisher Wallace Labs


>> OUR CAMPAIGN CLOSES SOON. Invest $1500+ in this campaign to obtain a free device and bonus shares.

01.19.23

LAST CALL

Are you, or is someone you know, a first responder?

The first responder mental health and wellness study we launched in collaboration with the Seattle Police Department and Washington State University is nearing full enrollment (200 subjects).

Lean more about the study here.

Participants receive a free Fisher Wallace device at the end of study.


You may also invest $1500+ in this campaign to receive a free device (and bonus shares)

01.18.23

Our Hardware Development History

Dear Investors, below is a visual history of Fisher Wallace's hardware development, beginning with the core technology that Fisher Wallace acquired in 2007 from the electrical engineers Saul and Bernard Liss. Our campaign closes next month, and we are offering bonus shares and free device perks for investors.


2000

"The Liss Cranial Stimulator"
(Engineered by Saul and Bernard Liss)



2007

"The Fisher Wallace Stimulator"



2015
"Mishka X Fisher Wallace Stimulator"
(Limited Edition of 100 Devices)



2016
Circadia
(Prescription-Strength Wellness)



2017
Kortex
(Brain Stimulation + VR Therapy)
(Limited Edition of 2000 Devices)



2023
OAK



We are proud to be a patient-owned healthcare company.

01.17.23

THE TECH CHALLENGE WE SOLVED

The Technological Challenge That Fisher Wallace Solved

Modern electroconvulsive therapy (ECT) remains the most effective treatment for Major Depressive Disorder: 70.6% of patients respond to ECT ("response" defined as 50% or greater reduction in symptoms). Among patients with Major Depressive Disorder and psychotic symptoms, the response rate rises to 78.9%. (See the 2018 journal article on ECT effectiveness here)

While remarkably effective - more so than any other device or drug - ECT requires anesthesia (patients are unconscious during the procedure) and may cause memory loss. To achieve its clinical goals, ECT relies on a high dose of Transcranial Alternating Current Stimulation (tACS) administered 2 - 3 times per week for 3 - 6 weeks.

Our founding electrical engineers endeavored to solve the following problem/question: How can we produce effectiveness that is comparable with Electroconvulsive Therapy for the treatment of depression in a wearable form factor that is comfortable and easy to self-administer, and poses near-zero risk to patients?

Like ECT, our technology is a form of Transcranial Alternating Current Stimulation (tACS) - but our device delivers a low dose of tACS and relies on twice-daily usage to treat depression. Whereas a patient with severe depression may receive 12 ECT sessions over a 4-week period, our technology is used 56 times over 4 weeks (twice daily for 28 days, 20-minutes per session, self-administered at home). Instead of delivering a seizure-inducing 800 mA (milliamperes) of electricity as ECT does, our device delivers approximately 2mA of electricity: 1/400th of the electricity of ECT, but delivered much more frequently, and with a unique 3-frequency package (15,000 Hz is our carrier frequency).

In our most recent clinical trial, which was submitted to the FDA to obtain approval for the treatment of Major Depressive Disorder, our technology produced a response rate by week 4 that is very close (a few percentage points less) than ECT when treating Major Depressive Disorder without psychotic symptoms. Our study therefore demonstrates that our founding engineers succeeded in producing comparable effectiveness to ECT, but with none of the downsides. ECT costs about $1000 per treatment session - so $12,000 for 12 treatments. Our Version 2.0 device, OAK, is set to retail for $699.

Our equity crowdfunding campaign closes next month. Thanks for considering to become an early investor in Fisher Wallace.

Best regards,

Kelly Roman

Co-Founder and CEO

Fisher Wallace Labs


Invest $1500+ in this campaign to obtain Version 1 or OAK for free.




01.06.23

$400K RAISED IN PAST 30 DAYS

Dear Investors,

Thanks to our passionate customers and the vibrant StartEngine community, we have succeeded in raising approximately $400K in the past 30 days, bringing our total raised on StartEngine to over $7.5 million (via multiple campaigns).  When we started raising capital on StartEngine in 2019, we hadn't completed any large scale clinical research or launched OAK product development. Today, only four months of engineering remain for OAK, and last month we submitted the results of our pivotal depression trial (a 255-subject, triple-blind, randomized controlled trial) to the FDA to obtain approval to treat depression.

Our campaign closes next month - more updates coming soon!

Best regards,

Kelly Roman

Co-Founder & CEO

Fisher Wallace Labs


Invest $1500+ in this campaign to receive OAK or our Version 1.0 device for free - plus receive bonus shares. 

01.04.23

DEPRESSION TREATMENT NEEDS LESS FRICTION AND MORE ACCESS


"Depression treatment needs less friction and more access. Through OAK, we are introducing a clinical product that has an innate ability to create desire. Medicine you can wear, without serious side effects, accessible without insurance. Depression is most prevalent in Gen Z, but Gen Z uses antidepressant medication less frequently than older generations - OAK has the potential to ignite generational change in how depression is treated globally."

- Kelly Roman, CEO, Fisher Wallace Labs


We've extended our equity crowdfunding campaign through February 22nd.

This is a one-time extension that allows our customers, prescribers and StartEngine investors to invest at the same terms that were offered last month. We have begun working with a Silicon Valley law firm to explore venture capital opportunities in the next few weeks and reserve the right to close our crowdfunding campaign before February 22nd.

Invest $1500+ to obtain a device for free. 

01.03.23

OBTAIN A FREE DEVICE

When you invest $1500 in our campaign, you are entitled to bonus shares and a free Version 1 or Version 2 device. A free prescription process is included in checkout. A coupon code to receive the free device will be distributed immediately upon the close of our campaign next month.

Stay tuned for more exciting updates!

12.30.22

OUR CEO INTERVIEW ON THE TECHLINK HEALTH PODCAST

Episode Description

"Mental health is the #1 healthcare cost in the US, greater than cancer, diabetes or heart disease. This episode focuses on prescription wearables and neuro-technologies and the role they play in helping to evolve the healthcare industry, with a particular focus on mental health and the treatment of depression, anxiety, and insomnia. The topic is timely as mental health continues to be a fundamental part of holistic health and longevity, particularly as many look toward new normals in a post-pandemic world. Other insights in the episode range from the future of brain health metabolism and the potential impacts to the prevention of Alzheimer's and dementia, to best practices on what to look for when considering wellness devices, to how brain stimulation devices can be used to promote police officer and military veteran wellness. Also, what about electroceuticals? This episode’s guest is Kelly Roman, Co-Founder & CEO at Fisher Wallace Labs, a prescription wearable company pioneering the first hardware category to effectively compete with drug therapy for the treatment of depression, anxiety and insomnia. The Fisher Wallace mission is tied to making prescription wearables a preferred alternative to prescription medication."


Link to the 26-minute episode.


Invest $1500+ to obtain a Fisher Wallace brain stimulation wearable for free, along with bonus shares.

Owners bonus
Stack Owner's Bonus & Rewards!

Members get an extra 10% shares in addition to rewards below!

REWARDS

Multiple investments in an offering cannot be combined to qualify for a larger campaign perk. Get rewarded for investing more into Fisher Wallace.

$493.00

StartEngine Owner’s Bonus

This offering is eligible for the StartEngine Owner’s 10% Bonus program. For details on this program, please see the Offering Summary section below.

$1,500.00

Tier 1

Invest $1,500 and receive 2% bonus shares + a free device.

$5,000.00

Tier 2

Invest $5,000 and receive 5% bonus shares + a free device.

$10,000.00

Tier 3

Invest $10,000 and receive 10% bonus shares + a free device.

$25,000.00

Tier 4

Invest $25,000 and receive 15% bonus shares + a free device.

JOIN THE DISCUSSION













0/2500

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Cancel anytime before 48 hours before a rolling close or the offering end date.

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PREVIOUSLY CROWDFUNDED
$7,229,887.64
RAISED
$740,645.94
INVESTORS
370
MIN INVEST
$493.36
VALUATION
$81.57M

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