Fisher Wallace Laboratories

Prescription Wearables For Mental Health

Fisher Wallace Laboratories

Prescription Wearables For Mental Health

Closing in 5 days
Brooklyn, NY
Health Tech
Fisher Wallace manufactures and markets prescription-only brain stimulation wearables that have been cleared by the FDA to treat depression, anxiety, and insomnia. The technology comfortably stimulates the brain to produce serotonin, lower cortisol, and modulate brain activity. The company is VC-backed and led by CEO Kelly Roman, who has helped pioneer the category since 2009.

$992,346

raised
$5,770,278
previously crowdfunded
543
Investors
$80M
Valuation
$8.76
Price per Share
$499.32
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.9M
Offering Max
5
Days Left

$992,346

raised
$5,770,278
previously crowdfunded
543
Investors
$80M
Valuation
$8.76
Price per Share
$499.32
Min. Investment
Common
Shares Offered
Equity
Offering Type
$1.9M
Offering Max
5
Days Left

Rewards

Get rewarded for investing more into Fisher Wallace Laboratories:

$499+
Investment
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+
Investment
Tier 1
Invest $1,500 and receive 2% bonus shares + a free device.
$5,000+
Investment
Tier 2
Invest $5,000 and receive 5% bonus shares + a free device.
$10,000+
Investment
Tier 3
Invest $10,000 and receive 10% bonus shares + a free device.
$25,000+
Investment
Tier 4
Invest $25,000 and receive 15% bonus shares + a free device + a 30-minute zoom with our CEO.

Reasons to Invest


  • Over $30 million in lifetime net revenue and 80,000 sales of Version 1 device; Version 2 designed by Eric Fields (Beats, Nest) and engineered by Alloy Product Development (Beats, Microsoft) for release in 2023.


  • Currently FDA-Cleared and pursuing new FDA-Approval for the treatment of Major Depressive Disorder.


  • $5.7 million raised previously on StartEngine, and $2.5 million raised from VC firm SHUFL Capital.




Overview


Meet Fisher Wallace: developing a new standard of care

*These products are currently under development and not yet available on the market.


Fisher Wallace has developed a wearable medical device that electrically stimulates the brain to treat psychiatric disorders without causing serious side effects. The company’s proof-of-concept device, the Fisher Wallace Stimulator®, has been cleared by the FDA to treat depression, anxiety and insomnia and has been purchased by over 80,000 patients.


In 2021, the company submitted data to the FDA from anxiety and insomnia research conducted during the pandemic and is awaiting the agency's decision on new anxiety and insomnia clearances. In early 2022, the company launched a pivotal clinical trial to obtain FDA-Approval for the treatment of Major Depressive Disorder. The depression data submission deadline is December 11, 2022, and the FDA is expected to render an Approval decision by early 2023. 


In a pilot study conducted at Mount Sinai Beth Israel Hospital in 2015, subjects who used an active Fisher Wallace device experienced durable depression relief, while subjects who used a placebo device returned to baseline. This scientific data, in combination with the anecdotal data from Fisher Wallace's 80,000+ patients and 14,000+ prescribers, informed the company's decision to raise capital to pursue full FDA-Approval.


In tandem with scientific research, the company is developing a Version 2.0 device (see images above) under a new brand name that will feature precisely the same therapeutic output as Version 1.0 but with industrial design from Eric Fields - the award-winning designer of the Nest thermostat and the Beats pill. Alloy Product Development - the engineers of Beats and Microsoft products - is providing the electrical and mechanical engineering. 


In 2023, Fisher Wallace intends to disrupt the mental health industry with a beautifully designed, FDA-Approved Version 2.0 device that is affordable out-of-pocket and prescribed via telemedicine on its e-commerce store.




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). 

the problem


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


SSRI medication causes side effects that include nausea, sexual problems and weight gain (source). 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).


the solution


Rapid treatment with minimal side effects


Patients use the technology for 20 minutes, once or twice a day, easily integrating usage into their daily routine. The company provides its customers a 30-day full refund policy, allowing them to try the device without the risk of losing any money if treatment is unsuccessful. In a recent customer survey, 76.5% of Fisher Wallace customers stated that they intend to use the device for the rest of their life to maintain mental health and cognitive performance, and 26.9% stated that the device is more important than their cell phone.


*These products are currently under development and not yet available on the market.

our traction


Proven product-market fit and scalability



By leveraging a vertically integrated e-commerce model in which a free prescription process is integrated into checkout, Fisher Wallace has succeeded in generating over $30 million in net revenue.


The Seattle Police Department launched a pilot study with the Fisher Wallace device in January 2022 and it is scheduled to be completed by Summer 2022. If successful, this study will inform a purchase decision for additional devices from SPD and will allow Fisher Wallace to market its solution to police departments and other first responder communities nationally.


Medicaid in Maine (MaineCare) became the first state Medicaid program to fully cover the purchase of the Fisher Wallace device. Broad insurance coverage is possible if the company obtains additional FDA Clearances and Approvals - however, at the current $499 retail price, the device is affordable to many patients out-of-pocket.


Version 2.0 will serve as an upgrade for the company's many Version 1.0 customers and is intended to provide brand leadership in the prescription wearable category for years to come.


*These products are currently under development and not yet available on the market.

why invest


Join us as we usher in a new era of mental health treatment


*These products are currently under development and not yet available on the market.


With years of product development, clinical research, regulatory and marketing experience, and over $30 million in lifetime revenue and $8 million in capital raised, our team is uniquely prepared to bring a refreshing vision of mental healthcare to life. We believe we possess the tech, talent, and timing required to successfully scale a new standard of care for those suffering from common mental health conditions. Become a shareholder in Fisher Wallace and help make mental health treatment better and more accessible for everyone. Invest $1500+ and receive the company’s Version 1.0 device (available now) or Version 2.0 device (available in 2023) for free!




In the Press

Forbes Magazine

One of 4 Technologies Innovating Mental Health

Entrepreneur

5 Health-Tech Startups to Watch in 2021

Elle Magazine

Could A Shock-Delivering Headband Cure Depression?

The Wall Street Journal

Using Electricity, Magnets for Mental Illness

Offering Summary


Company

:

Fisher Wallace Laboratories Inc.

Corporate Address

:

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

Offering Minimum

:

$9,995.16

Offering Maximum

:

$1,899,991.44

Minimum Investment Amount

(per investor)

:

$499.32











Terms


Offering Type

:

Equity

Security Name

:

Class B Non-Voting Common Stock

Minimum Number of Shares Offered

:

1,141

Maximum Number of Shares Offered

:

216,894

Price per Share

:

$8.76

Pre-Money Valuation

:

$80,048,888.76











*Maximum Number of Shares Offered subject to adjustment for bonus shares. See Bonus info below.

Investment Incentives and Bonuses*

Time-Based:

Super Early Bird Bonus

Invest within the first 72 hours and receive 10% bonus shares.

Early Bird Bonus

Invest within the first week 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 + a 30-minute zoom with our CEO.

*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 $8.76 / share, you will receive 110 shares Class B Non-Voting Common Stock, meaning you'll own 110 shares for $876. 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 only receive a single bonus, which will be the highest bonus rate they are eligible for.

Irregular Use of Proceeds

We will not incur any irregular use of proceeds.

Show More
Most recent fiscal year-end:
Prior fiscal year-end:
Total Assets
$1,999,403.00 USD
$853,359.00 USD
Cash And Cash Equivalents
$1,929,380.00 USD
$695,749.00 USD
Accounts Receivable
$0.00 USD
$2,302.00 USD
Short Term Debt
$966,198.00 USD
$1,094,023.00 USD
Long Term Debt
$576,525.00 USD
$620,416.00 USD
Revenues And Sales
$4,230,290.00 USD
$4,250,866.00 USD
Costs Of Goods Sold
$623,703.00 USD
$970,761.00 USD
Taxes Paid
$250.00 USD
$1,597.00 USD
Net Income
-$3,262,291.00 USD
-$1,823,732.00 USD

Risks

A crowdfunding investment involves risk. You should not invest any funds in this offering unless you can afford to lose your entire investment. In making an investment decision, investors must rely on their own examination of the issuer and the terms of the offering, including the merits and risks involved. These securities have not been recommended or approved by any federal or state securities commission or regulatory authority. Furthermore, these authorities have not passed upon the accuracy or adequacy of this document. The U.S. Securities and Exchange Commission does not pass upon the merits of any securities offered or the terms of the offering, nor does it pass upon the accuracy or completeness of any offering document or literature. These securities are offered under an exemption from registration; however, the U.S. Securities and Exchange Commission has not made an independent determination that these securities are exempt from registration.


Updates

BEATS AND NEST DNA

3 days ago

Two-time recipient of the Red Dot Award (the most prestigious award for an industrial designer), Eric Fields previously designed the first Nest thermostat and the Beats Pill (which made remarkable use of iridescent fabric). Above is a recent photo of his table in San Francisco with 3D-printed components of our Version 2.0 device. These components do not display the color and richness of our fabric choices, or the quality of world-class tooling and injecting molding - we look forward to sharing those details soon. Next week, we will introduce the brand name of Version 2.0, which we developed in collaboration with Pearlfisher. Stay tuned, and thank you for becoming an early investor in Fisher Wallace, one of the world's leading prescription wearable startups.


OUR CAMPAIGN CLOSES IN 8 DAYS

GEEK OUT WITH US

4 days ago

Dear Investors,

We're obsessed with science at Fisher Wallace. Our customer service team includes a biomechanical engineer and a doctoral student who studied in one of the nation's leading brain stimulation labs.

If you want to dive deep into the science behind our technology - called Transcranial Alternating Current Stimulation (tACS) - the best place to search is PubMed, the NIH's repository of published studies. Here's the link to 125 studies that have been published on tACS so far - the majority conducted using lab-built tACS devices. Our device is one of very few commercialized tACS devices, and our electrode placement and output are unique. CES (Cranial Electrotherapy Stimulation) is what tACS is called when it's regulated / marketed to treat depression, anxiety and/or insomnia. Here is one of our pilot studies on PubMed.

Best regards,


Kelly Roman

Co-founder and CEO

Fisher Wallace Labs

Our campaign closes in 9 days!

OUR BIG BET ON FDA APPROVAL

6 days ago

Dear Investors,

With 11 days left in our campaign, I want to highlight the bet we are making on FDA Approval. The FDA has given us until Dec 11, 2022 to file our approval application with new depression treatment data. This is why we recently launched a 250-subject Major Depressive Disorder study in collaboration with Climb.care, a leading remote clinical trial platform, and NAMSA, one of the world's largest clinical research organizations (CRO). We anticipate completion of data collection by the end of August and completion of the research report in September, after which we'll be ready to submit to FDA well before the December deadline. It's important to submit the data before the deadline to allow for back-and-forth communications with the agency - this communication time is deducted from the submission clock (if a company were to submit on Dec 10, there would be almost no time allowed for communication).

We do not know if our depression trial is going to succeed - there are many variables that can impact results. What we do have are strong signals from previous research, such as our smaller bipolar depression study which was published in 2015, and the avalanche of positive reviews we've received from patients and prescribers. But clinical trials are tricky because of the enormous number of exclusion and inclusion criteria applied to recruitment, in order to get a "pure" patient population for an FDA indication - for every patient admitted into the trial, far more will be excluded. This is very different than the real-world commercial sales process which is open to a wide array of patients - essentially, to any patient suffering from depression. A mental health clinical trial almost always examines only a small slice of the overall patient population - therefore, the signals we have are just signals, not a guarantee of success.

If we succeed, we will likely become the first wearable technology to  receive FDA Approval to treat depression - a status that would transfer to our Version 2 device as we are taking great care to ensure it delivers identical treatment (albeit in a much more attractive form factor).

The stakes are very high - and we may fail.  But such risks must be taken to truly transform depression treatment on a global scale.

Best regards

Kelly Roman

CEO, Fisher Wallace Labs


IN THE NEWS

9 days ago

Dear Investors,

Two additional pieces of coverage in Extreme Tech and NEO.LIFE are keeping attention on our innovation.

Our campaign closes in 2 weeks - thanks for your consideration!

Best,

Kelly Roman

CEO, Fisher Wallace Labs

IMPORT TARIFFS UPDATE

10 days ago

Dear Investors

This week the White House signaled that import tariffs may be relaxed in an effort to reduce inflation. Fisher Wallace currently pays a 25% import tariff on the devices we manufacturer overseas. Reducing or eliminating this tariff would have a positive material impact on our business - over the past 10 years we have decreased, not increased, our retail price in an effort to make mental healthcare affordable. Stay tuned!

Best, 

Kelly Roman

Co-founder and CEO

Fisher Wallace Labs


Our campaign closes in 15 days.  Invest $1500+ to receive a free device.

IN THE NEWS

13 days ago

Dear Investors,

Our last 3 campaign updates were posted to our previous Reg A+ campaign page instead of our current campaign, so I'm reposting two of them (combined) now:

I'm pleased to announce that GeekWire, the leading news website for technology and startups, just published the following article featuring Fisher Wallace: "Seattle Police Department testing brain stimulation headband as part of wellness research effort."

“There is a group of people that select into law enforcement that don’t generally think twice about risking their safety for somebody else, but they often have a difficult time taking care of themselves, or accessing self-care,” Loren Atherly, director of performance analytics and research at SPD, told GeekWire.

---------------Above is a visual engineering status update for Version 2.0 from Alloy Product Development - our lead engineering partner that previously developed the Beats headphones and Microsoft HoloLens.

Best regards,


Kelly RomanCEO, Fisher Wallace Labs


Our campaign ends in less than 3 weeks.

Notice of Material Change in Offering

24 days ago

[The following is an automated notice from the StartEngine team].

Hello! Recently, a change was made to the Fisher Wallace Laboratories offering. Here's an excerpt describing the specifics of the change:


Issuer is extending the campaign and updating their financials per the most recent fiscal year.


When live offerings undergo changes like these on StartEngine, the SEC requires that certain investments be reconfirmed. If your investment requires reconfirmation, you will be contacted by StartEngine via email with further instructions.

WHY DO WE VALUE TECHNOLOGY?

26 days ago


Despite all the wealth creation and technological advancements of the past 50 years, half the country still suffers from depression, anxiety or insomnia.

How should we measure the value of civilization's progress? 

Fisher Wallace is not here to change the world. We are here to change people, one at a time, and hope that the people we change for the better end up changing the world for the better by solving the root problems.

WE HAVE PARTNERED WITH SPD

27 days ago

We have partnered with the Seattle Police Department - SPD - in a pilot program enrolling uniformed police officers.

"Acting as public servants, police officers will often put the wellbeing of others in front of themselves. The stress of responding to tragic events happening in our community has significant impacts on officer wellness that accumulates over the course of a career," said Seattle Police Department Chief Adrian Diaz. "By engaging in this partnership with Fisher Wallace, we're hopeful to identify resources and treatment solutions for our officers who have experienced on-the-job stress impacting their mental and emotional health."


OBTAIN A FREE DEVICE

27 days ago

Invest $1500+ and receive a free Version 1 (shipped after the close of this campaign) or Version 2 device (in 2023).




ENTREPRENEUR MAGAZINE

29 days ago

Fisher Wallace was named one of "5 Health-Tech Startups to Watch" by Entrepreneur magazine.

Thanks to our investors, we are pioneering a prescription wearable revolution.

We invite you to watch our new campaign video if you have not already - and have a great weekend!

OUR NEW WEBSITE IS LIVE

about 1 month ago

After investing over $100K in redesigning our eCommerce website, it's now live as of a few hours ago. Please visit fisherwallace.com when convenient and let us know in the comments section of our StartEngine campaign if you have any suggestions - we will be making tweaks throughout the day tomorrow.

Last year we generated over $4 million in net sales from a website designed 10 years ago - we anticipate this new site to significantly improve our performance.

Thanks for your consideration!


RETIRED US ARMY GENERAL DISCUSSES OUR DEVICE

about 1 month ago


Invest $1500+ and receive our Version 1 or Version 2 device for free.

$700K RAISED IN TWO WEEKS

about 1 month ago


Dear Investors

We appreciate your enthusiasm for Fisher Wallace - over $700K raised in two weeks. 

Our collaboration with the Seattle Police Department was just covered in Mobile Health Times and the Puget Sound Business Journal.

Onwards and upwards!

HOW THE (ENGINEERING) SAUSAGE IS MADE

about 1 month ago

Version 2 is not just an idea - it's now coming to life within the offices of our mechanical and electrical engineering partner, Alloy Product Development - the team behind Beats and the Microsoft HoloLens.

This is how innovative depression treatment is designed in the year 2022.

Invest $1500+ and receive either Version 1 (available now) for free, or reserve a free Version 2 device.

WHAT COLOR WOULD YOU LIKE?

about 1 month ago

What colors or patterns would you like to see available in our Version 2 device? Please leave a comment on our campaign page with your suggestion! Hardware color and sponge electrode color can match - or be completely different. We are currently considering the colors below, as well as more radical options. 

Invest $1500+ and receive Version 1 (available now) or Version 2 (available in 2023) for free.

Have a great weekend!


WE'RE A STARTUP BUT NOT JUST AN IDEA

about 1 month ago

Fisher Wallace is a startup but not just an idea.  Our Version 1 "Proof of Concept" device has generated over $30 million in lifetime revenue. That's a powerful launchpad for our Version 2 device - our 80,000+ past customers will welcome an upgrade, and a whole new generation of users will find our Version 2 device far more approachable than Version 1. We have invested millions of dollars in research because we know the public and the medical community don't want false promises commonly associated with wellness products and supplements - they want hard science supporting the claims. We've transformed the lives of tens of thousands of patients, and look forward to transforming millions more.

Join us on this journey today and receive a free Version 1 or Version 2 device with a $1500+ investment.



FREE DEVICE WITH A $1500+ INVESTMENT

about 2 months ago

FREE PERK DEVICES WILL SHIP IMMEDIATELY AFTER OUR CAMPAIGN CLOSES


Dear Investor,

Our Version 1 device is in stock and ready to ship as a free perk as soon as the campaign closes in 24 days.

Version 1 is cleared by the FDA to treat depression, anxiety and insomnia. When you make a $1500+ investment, you will receive a coupon code that will allow you to checkout of our online store with a free device following the free prescription process during checkout. We are allowed to distribute these coupon codes after our StartEngine campaign closes. 

Please let us know in the comments section if you have any questions!

Best,

Kelly Roman

Co-Founder and CEO

Fisher Wallace Laboratories

OUR 3 MOST COMMON TYPES OF CUSTOMERS

about 2 months ago

Jennifer "Fer" Wang, our new Chief Marketing Officer (she started March 1), is reshaping how Fisher Wallace markets its mental health solution. Our new website will launch later this month, and Fer just hired a new full time Social Media Manager and Paid Ads Manager who start work this month. Among our 80,000+ current customers, here are the 3 most common patient archetypes:


1) "I take medication and find it helpful, but it doesn't provide enough relief - I still need something to dramatically reduce my symptoms on a daily basis."


2) "I used to take medication - I tried many different kinds - but none of it provided significant relief and on top of that, I didn't like the side effects."


3) "I don't want to take medication for my mental health and never plan to - I don't trust it."


Our new website, advertising and social strategy will speak directly to these three kinds of patients.

Stay tuned.

VERSION 2 COMING TO LIFE

about 2 months ago


The latest 3D print fits like a dream.

Best, Kelly Roman

CEO, Fisher Wallace Laboratories


Invest $1500 and receive a free Version 2 device, plus bonus shares.

Campaign closes this month.

THE BRAIN IS AN ELECTRICAL SYSTEM

about 2 months ago

This is why Fisher Wallace developed a prescription wearable device to electrically stimulate the brain to treat common mental health conditions - in a way that is safe, comfortable to use and validated in multiple published studies.

We've raised over $600K in less than a week and look forward to continuing to build a valuable enterprise that helps people feel better and sleep better. 26 days remain to invest - thanks for your consideration! 

FINAL EARLY BIRD BONUS ENDING

about 2 months ago

Receive 5% bonus shares when you invest in Fisher Wallace Laboratories today. 

With over $30 million in lifetime revenue and a Version 2 device designed by the talent behind Beats, Nest and the Microsoft HoloLens, Fisher Wallace is one of the world's leading prescription wearable startups. 

Invest $1500+ and receive a free device (after a free prescription process).


FEATURED IN AXIOS

about 2 months ago


Great to see Axios Pro Rata announce our recent VC investment from SHUFL Capital. The combination of traditional venture capital and progressive equity crowdfunding is becoming a new paradigm for medtech startups like Fisher Wallace to disrupt healthcare.


SUPER EARLY BIRD BONUS ENDING!

about 2 months ago


The next few hours is the best time to invest in the company that is designing prescription wearables for Big Pharma scale.


OUR WORK WITH THE SEATTLE POLICE DEPARTMENT

about 2 months ago

The best moment of 2022 so far has been receiving this friendship coin from Seattle Police Chief Adrian Diaz, thanking us for our collaboration on a pivotal mental health study with SPD that launched in January. 

Improving mental health among veterans and first responders has been a focus of our mission from Day 1, and we look forward to scaling up partnerships like this in the future.

It's wonderful to see that we've raised over $300K in the first two days of our very short StartEngine campaign. 

Much appreciated, 

Kelly Roman

CEO, Fisher Wallace

BTW our Super Early Bird bonus ends in about 12 hours!

$100K OUR FIRST DAY!

about 2 months ago

We raised $100K on our first day!

In addition to our investors, we want to send a big thanks to Axios and Fortune for announcing our funding round, and to Entrepreneur magazine for naming us one of "5 Health-Tech Startups to Watch"!

Our Super Early Bird bonus (10% bonus shares in addition to any other perks) will end at midnight EST tomorrow.

Invest $1500+ and receive more bonus shares and a free Version 1 (available now) or Version 2 device (launching in 2023):



WE'RE BACK FOR A SHORT TIME!

about 2 months ago

Dear Investors,

Fisher Wallace is building a new category of prescription wearables to address the $225 billion mental health treatment market in the US.

Today we launched a short campaign to fund for our remaining research initiatives and product development.

Over the past three years, thousands of our customers have joined VC firm SHUFL Capital to fund $8.2 million of our clinical research, product development, and other growth initiatives.

We've generated over $30 million in lifetime revenue, funded five clinical trials (including one currently being conducted by the Seattle Police Department) and are building a new generation of prescription wearable technology for release in 2023. 

Invest over the next two days and receive 10% bonus shares as a "Super Early Bird."

Invest $1500+ and receive additional bonus shares and a free Version 2 device.

Thanks for your consideration!

Kelly Roman

Co-Founder & CEO, Fisher Wallace Laboratories

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