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

Medical Devices for Mood and Sleep

INVEST IN FISHER WALLACE LABORATORIES TODAY!

Fisher Wallace is a leading non-surgical electronics company for the brain. Our first product, the Fisher Wallace Stimulator®, is FDA-Cleared to treat depression, anxiety and insomnia. The device has been used by over 70,000 patients and is currently undergoing review by the FDA for new Approval and Clearance.
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This Reg A+ offering is made available through StartEngine Primary, LLC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
Fisher Wallace Laboratories

Reasons to Invest



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


SUCCESS SINCE OUR LAST RAISE




  • 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%.



THE PROBLEM


Drug therapy provides low to modest efficacy with a high rate of side effects and high cost


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 SOLUTION



FDA regulated wearable treatment - just 20 minutes per day





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. 




OUR TRACTION



Over 70,000 patients treated, and multiple clinical trials completed


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


What We do



Symptom reduction in the first week for most patients


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.

THE MARKET


As a result of the pandemic, the rate of depression and anxiety among US adults has skyrocketed to 31

(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;





HOW WE ARE DIFFERENT



The first hardware category to effectively compete with drug therapy for the treatment of depression, anxiety and insomnia


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.





THE BUSINESS MODEL


Expanding from out-of-pocket to broad insurance coverage


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.




THE VISION


To become the world’s leading non-surgical electronics company for the brain - starting with a new standard of care for depression, anxiety and insomnia


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

OUR TEAM


Leaders in their field


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

WHY INVEST



A clear path to new FDA Approval and Clearance for the treatment of depression, anxiety and insomnia


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.


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.


WHILE THE COMPANY HAS SIGNED A QUOTATION AGREEMENT TO TRADE THE SECURITIES OFFERED ON STARTENGINE SECONDARY’S NEW ALTERNATIVE TRADING SYSTEM (THE “ATS”), A COMPANY WHICH INTENDS TO BE QUOTED ON THE MARKETPLACE WILL BE SUBJECT TO CERTAIN REQUIREMENTS WHICH THE COMPANY MAY OR MAY NOT BE ABLE TO SATISFY IN A TIMELY MANNER. EVEN IF A COMPANY IS QUALIFIED TO QUOTE ITS SECURITIES ON THE MARKET, THERE IS NO GUARANTEE AN ACTIVE TRADING MARKET FOR THE SECURITIES WILL EVER DEVELOP, OR IF DEVELOPED, BE MAINTAINED. YOU SHOULD ASSUME THAT YOU MAY NOT BE ABLE TO LIQUIDATE YOUR INVESTMENT FOR SOME TIME OR BE ABLE TO PLEDGE THESE SHARES AS COLLATERAL.



ABOUT

HEADQUARTERS
brooklyn
Brooklyn, NY 10028
VALUATION
$40M

Fisher Wallace is a leading non-surgical electronics company for the brain. Our first product, the Fisher Wallace Stimulator®, is FDA-Cleared to treat depression, anxiety and insomnia. The device has been used by over 70,000 patients and is currently undergoing review by the FDA for new Approval and Clearance.

TEAM

Kelly Roman
Kelly Roman
Co-Founder & CEO & Director

For the past decade, Kelly Roman has helped lead the fields of neuromodulation 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 Fisher
Charles Fisher
Co-Founder & Chairman & Director

Charles “Chip” Fisher grew up in the electronics business before helping pioneer the neuromodulation industry - his father, Avery Fisher, founded Fisher Radio (later named 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 largest shareholder - and recent TEDx contributor.

TERMS

Fisher Wallace Laboratories
Overview
PRICE PER SHARE
$6.21
DEADLINE
Oct 27, 2021
VALUATION
$40M
AMOUNT RAISED
$4,666,618.29
Breakdown
MIN INVESTMENT
$496.80
MAX INVESTMENT
$1,999,998.81
MIN NUMBER OF SHARES OFFERED
80
OFFERING TYPE
Equity
ASSET TYPE
COMMON
SHARES OFFERED
Class B Common Stock
MAX NUMBER OF SHARES OFFERED
1,674,718

Maximum Number of Shares Offered subject to adjustment for bonus shares


Company

:

Fisher Wallace, Inc

Corporate Address

:

brooklyn, Brooklyn, New York 10028

Offering Minimum

:

$0.00

Offering Maximum

:

$10,399,998.78

Minimum Investment Amount

(per investor)

:

$496.80











Terms


Offering Type

:

Equity

Security Name

:

Class B Common Stock

Minimum Number of Shares Offered

:

0

Maximum Number of Shares Offered

:

1,674,718

Price per Share

:

$6.21

Pre-Money Valuation

:

$40,000,001.04











Time-Based:

Super Early Bird Bonus

Invest within the first 48 hours and receive an additional 10% bonus shares

 

Early Bird Bonus

Invest within the first week and receive an additional 5% bonus shares

 

Amount-Based: 

$1500+

Free Device

2% Bonus Shares

You will receive a unique coupon code for a free device. 

 

$5000+

Free Device

5% Bonus Shares

You will receive a unique coupon code for a free device.

 

$10,000+

Free Device

10% Bonus Shares

You will receive a unique coupon code for a free device.

 

$25,000+

Free Device

15% Bonus Shares

Zoom with CEO

You will receive a unique coupon code for a free device and a 30-minute zoom with our CEO.

 

The 10% StartEngine Owners’ Bonus

FIsher Wallace Laboratories, Inc. will offer 10% additional bonus shares of Common Stock 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 of Class A Common Stock (Non-Voting) which they purchase in this offering. For example, if you buy 100 shares of common shares at $1.00 / share, you will receive and own 110 shares for $100. 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 investors' 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.

ALL UPDATES

05.09.22

FEATURED IN GEEKWIRE

Dear Investor,

I am 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.

Best regards,


Kelly RomanCEO, Fisher Wallace Labs


Our campaign ends in less than 3 weeks.

05.05.22

CAMPAIGN CLOSING SOON

Dear Investors, 

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

We are  closing our campaign on May 27th and will not extend it further.

Invest $1500+ to receive a free Version 1 or Version 2 device.



"One of four technologies innovating mental health." - Forbes


Our technology has been cleared by the FDA to treat depression, anxiety and insomnia.



04.29.22

5 STAR REVIEW

One of hundreds of 5 star reviews:

"I'm a careful and somewhat skeptical person--if not meticulous, than at least careful. I'd looked at the Fisher Wallace device a number of times and finally decided to order one in December 2021. I wasn't at my lowest (by any means) then but decided that not only was the time right, but so was the price.I noted on the whiteboard in my office that I commenced using the device Wednesday, 10 December 2021 and found the sessions short and non-disruptive. I had no boundless high hopes but was willing to go through the motions, one way or the other.At roughly the two-week mark, I noticed a definite lightening of the mood that had hung over me (occupied me? possessed me?) for months and months--and which, to be honest, I'd been subject to for roughly 60 years."

by D. B. Robinson, real patient


Individual results may vary.


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

03.29.22

WE ARE BACK FOR A SHORT TIME!

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

10.26.21

CAPITAL IS POURING IN DURING THE FINAL HOURS!

OFFER CLOSES AT MIDNIGHT!

Dear Investors,

Over the last 48 hours, hundreds of thousands of dollars of investment have poured in - thank you to all of our new investors who have made this one of the most successful raises in StartEngine history!  Everyone at Fisher Wallace is excited to move forward with a strong wind at our back as we work hard to transform the mental health industry with our groundbreaking prescription wearable platform. And a special thank you to all of our customers, many of whom have become investors - the journey continues!

Onwards and upwards!

Kelly Roman

Co-Founder and CEO

Fisher Wallace Laboratories, Inc.


Disclaimer: This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.

10.26.21

HOURS LEFT TO INVEST!

OFFER CLOSES TODAY!

Enjoy the closing update from our Co-Founder & CEO, Kelly Roman:


Invest $1500+ and choose either a Version 1 or Version 2 device as a free perk!

Thanks for your consideration,

Fisher Wallace Laboratories, Inc.



Disclaimer: This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.

10.25.21

SUPERCHARGING PROGRESS!!

OFFER CLOSES TOMORROW!

Dear Investor, 

I received the first crude but beautiful 3D print of our in-development Version 2 from designer Eric Fields over the weekend - a sign of how raising capital on StartEngine has supercharged our progress.  More iterations are yet to come, but to see the designs we are working on start to take physical form is very exciting.

We've changed the lives of tens of thousands of patients with Version 1 and intend to change millions more with Version 2. App development is also underway, and our new brand name, icons and guidelines development is nearing completion from Pearlfisher.

It will likely be sometime next year that FDA finalizes its regulatory process, but we are currently cleared to treat depression, anxiety and insomnia - hopefully we will have a new indication (for Generalized Anxiety Disorder) in the near future.  I will keep you updated on this front in the months ahead.

As always, if you invest $1500+ you may choose to receive a free Version 1 or Version 2 device.

Thank you for sharing our passion for changing how common mental health conditions are treated in the US and globally!

Best regards,

Kelly Roman

CEO, Fisher Wallace Labs

BTW I'm a collector of Star Wars themed artwork from Suckadelic - you can see a peek of one piece in the background of the above photo, in case you were wondering what that is! ;)



Disclaimer: This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.

10.21.21

5 DAYS TO GO!

OFFER CLOSES IN 5 DAYS!

We encourage you to watch a patient describe her experience using our Version 1 device.  Version 2 is slated to be released next year.


INVEST $1500+ AND RECEIVE A FREE VERSION 1 OR VERSION 2 DEVICE AS A PERK

Thanks for your consideration!



Disclaimer: This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.

10.20.21

$1500+ INVESTMENT = FREE DEVICE

OFFER CLOSES IN 6 DAYS


"One of four technologies innovating mental health." - Forbes


Invest $1500+ and receive a free device as a perk.



Disclaimer: This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.

10.19.21

BIG TECH <> MENTAL HEALTH. ONE WEEK TO GO!

OUR CAMPAIGN CLOSES IN A WEEK!

Recent articles in Techcrunch and The Wall Street Journal highlight how Big Tech is beginning to really focus on mental health innovation:

"Apple is reportedly working on ways to help detect and diagnose conditions such as depression, anxiety and cognitive decline using an iPhone. Researchers hope that analysis of data such as mobility, sleep patterns and how people type could spot behaviors associated with those conditions, according to The Wall Street Journal."

Timing is everything as Fisher Wallace moves to build a truly world-class wearable treatment platform in Version 2 - a device that not only tracks, but treats symptoms.

As always, if you invest $1500+ you may choose to receive our Version 1 or Version 2 device for free.

Best regards,

Kelly Roman

Co-Founder and CEO

Fisher Wallace Laboratories, Inc.




Disclaimer: This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.










REWARDS

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

$1,500.00

First Volume Tier

Free Fisher Wallace Device

$2,500.00

Second Volume Tier

Free Fisher Wallace Device and 2% bonus shares

$5,000.00

Third Volume Tier

Free Fisher Wallace Device and 3% bonus shares

$10,000.00

Fourth Volume Tier

Free Fisher Wallace Device and 4% bonus shares

JOIN THE DISCUSSION













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