Fisher Wallace offering is now closed and is no longer accepting investments.

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

$1,268,563.21 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.

Reasons Icon

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

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
$1,268,563.21
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.

ALL UPDATES

02.21.23

A FEW HOURS REMAIN


INVEST $1500+ TO OBTAIN A FREE DEVICE

02.20.23

OUR CAMPAIGN CLOSES AT MIDNIGHT PST

When our campaign launched, we had not yet completed or submitted the results of our pivotal depression trial to obtain FDA approval - that changed on December 9th, 2022 when we submitted our outstanding results to the FDA.  According to the FDA review clock, we will receive the Agency's decision by November 17th of this year.  Thank you for joining us as we continue to raise the bar for mental health treatment and address the needs of tens of millions of patients. 

Our campaign closes at midnight tonight (PST)

Invest $1500+ to obtain a free device

02.19.23

FREE DEVICE WITH $1500+ INVESTMENT - CAMPAIGN ENDS TOMORROW

Our Campaign Ends Tomorrow

Free Version 2.0 (with $1500+ investment)


Or Free Version 1.0 (with $1500+ investment) - Available Now

Our campaign ends tomorrow.

Obtain a free Version 1.0 (available now) or Version 2.0 device (engineering completion on track for end of summer) with a $1500 investment.


02.18.23

CAMPAIGN CLOSES MONDAY!

OUR CEO INTERVIEWED BY JASON MALKI OF STRTUPBOOST



READ THE ARTICLE

OUR CAMPAIGN CLOSES ON MONDAY

INVEST $1500+ TO OBTAIN A FREE DEVICE PERK

02.17.23

CAMPAIGN CLOSES IN 3 DAYS

We've now raised over $8M on StartEngine since 2019.

One clear result of putting that capital to work: the pivotal clinical trial submitted to the FDA for approval two months ago validates our technology as the only depression treatment that is simultaneously fast acting, highly effective, safe, and self-administered. 

Off the back of this data, we are now raising funds to: 

1) Complete our Version 2.0 device, OAK, which will carry forward any new FDA approval and was designed in collaboration with the teams behind Beats, Nest  and the HoloLens.

2) Launch anxiety and insomnia pivotal trials that leverage learnings from our previous research (in many ways replicating the success of our recent depression trial protocol) to lock in additional indications and expand the addressable market for OAK to more than half of the US adult population.

We believe this new category of device will ultimately achieve smartphone-level ubiquity, given the prevalence of depression, anxiety and insomnia and the scalability, safety and effectiveness of our solution. The FDA is scheduled to render a decision on approval before mid November of this year. FDA approval would establish a significant regulatory barrier to entry - a kind of tailwind for category leadership. A competitor must not only develop hardware, but conduct a pivotal clinical trial of similar scope and go through the FDA approval process - an endeavor that takes a significant amount of time during which Fisher Wallace will be growing.

While we cannot guarantee success, we've demonstrated our ability to put capital to work to position ourselves for success, year after year. Medical device hardware development and FDA approval are not quick and easy pursuits, but, to use the F1 analogy, we've successfully fought our way to pole position.

Best,

Kelly Roman

Co-Founder & CEO


OUR CAMPAIGN CLOSES IN 3 DAYS

INVEST $1500+ to obtain a free device



02.15.23

A new standard of care that works well with others.

A new standard of care that works well with others.



+/-




Our campaign closes on Monday. 

Obtain a free device with a $1500+ investment.

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

02.14.23

THE OPPORTUNITY


Depression is at scale.

Our wearable technology is the only fast-acting, highly effective, safe and self-administered treatment for depression.  And it's affordable out-of-pocket. 

Our campaign ends next week and will not be extended. 

Invest $1500+ to obtain a free device.


02.10.23

UPDATE ON SCIENTIFIC JOURNAL PUBLICATION

Our StartEngine Campaign Closes in 10 Days!


UPDATE ON SCIENTIFIC JOURNAL PUBLICATION

The results of our pivotal depression trial are being prepared for scientific journal submission. The lead author on the article is Philip Gehrman, PhD, CBSM, FAASM, who serves as Associate Professor of Clinical Psychology in Psychiatry at the Hospital of the University of Pennsylvania. The study’s principal investigator, Kyle Lapidus, MD, PhD, is co-authoring the article.

We expect the draft to be finalized in the next 2-3 weeks and we will keep you updated on submission progress. We will submit to our top choice first, and only apply to a second journal if the first journal declines. We anticipate that no more than three submissions will be required, and we are targeting one the most well known journals in the field of psychiatry first (the name of which we will keep confidential until acceptance is confirmed).

Once the article is published, the data will become public - most importantly, the data will help inform treatment decisions by mental health professionals. We expect journal publication to occur prior to the FDA rendering a decision on approval (the FDA’s decision will occur before November 17, 2023, per their statutory review clock).

We have shared confidential details of the study results with StartEngine’s compliance team in order to defend our public claims regarding the study’s success: the device has now been proven to be fast-acting, highly effective and pose extremely low risk.

No previous wearable device has generated definitive (large scale, sufficiently powered) published evidence of depression treatment success - and likewise, the FDA has never before approved a wearable device for the treatment of depression (our device is currently FDA-Cleared). These are milestones we are on track to achieve this year - it has taken many years and millions of dollars to get to this point.

We would not have gotten to this point without the thousands of investors, many of whom are our customers, who invested through StartEngine. I believe we are building a great business that will make an enormous impact on society - I do not see any other way to scale depression treatment to meet the enormous need without devices like ours. No other solution is simultaneously fast-acting, highly effective, extremely safe, self-administered and affordable out-of-pocket.


Sincerely,

Kelly Roman

Co-Founder and CEO

Fisher Wallace Labs


Invest $1500+ to receive a coupon code to obtain our Version 2.0 device OAK for free.

02.07.23

DELAY IN RESPONSE TO COMMENTS

Dear Investors,

The StartEngine platform has not been providing me email notifications when comments are left, and at other times when I have left replies (including today), the system has not consistently loaded the reply under the comment.  Additionally the Comments/Discussion section of the campaign page does not always appear when the campaign page loads, making it very difficult to track new comments manually. StartEngine is now aware of this issue and is working on it -  I apologize for the delay in response! I take both investor and customer communications very seriously - it's why we have live customer service for Fisher Wallace 7 days a week.  

Thanks,

Kelly Roman

02.06.23

OUR CEO INTERVIEWED BY STRTUPBOOST

Our Co-Founder and CEO, Kelly Roman, was recently interviewed by Jason Malki of StrtupBoost

Check out the interview here


"The 'Holy Grail' of depression treatment is one that is effective in the first week, affordable, convenient and poses near-zero risk.
Fisher Wallace has developed wearable brain stimulation technology that checks all those boxes,
and we are now laying the groundwork to scale that solution." - Kelly Roman


Our campaign closes in 2 weeks! It will not be extended.

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

We are proud to be a patient-owned company.

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

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

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.

JOIN THE DISCUSSION













0/2500

HOW INVESTING WORKS

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
$1,268,563.21
INVESTORS
637
MIN INVEST
$493.36
VALUATION
$81.57M

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