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INVEST IN FISHER WALLACE LABORATORIES TODAY!

Prescription Wearables For Mental Health

Fisher Wallace Labs makes wearable brain stimulation technology that has been prescribed by over 14,000 providers to treat mental health conditions. The company is pursuing FDA approval and building a Version 2.0 device called OAK.

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.

$21,734.79 Raised

REASONS TO INVEST

The company has sold over 100,000 units of its Version 1.0 device (over $40M in lifetime revenue) under temporary FDA clearance and is nearing completion of its Version 2.0 device called OAK.

The company completed a large clinical trial in pursuit of FDA approval for the treatment of depression, and has partnered on an anxiety study with the Seattle Police Department.

You qualify to obtain the company's Version 2.0 device for free when it’s released with an investment of $1500+ in this campaign.

FISHER WALLACE IS CONSIDERING UNDERTAKING AN OFFERING OF SECURITIES UNDER TIER 2 OF REGULATION A. NO MONEY OR OTHER CONSIDERATION IS BEING SOLICITED, AND IF SENT IN RESPONSE, WILL NOT BE ACCEPTED. NO OFFER TO BUY THE SECURITIES CAN BE ACCEPTED AND NO PART OF THE PURCHASE PRICE CAN BE RECEIVED UNTIL THE OFFERING STATEMENT FILED BY THE COMPANY WITH THE SEC HAS BEEN QUALIFIED BY THE SEC. ANY SUCH OFFER MAY BE WITHDRAWN OR REVOKED, WITHOUT OBLIGATION OR COMMITMENT OF ANY KIND, AT ANY TIME BEFORE NOTICE OF ACCEPTANCE GIVEN AFTER THE DATE OF QUALIFICATION. AN INDICATION OF INTEREST INVOLVES NO OBLIGATION OR COMMITMENT OF ANY KIND.  "RESERVING" SECURITIES IS SIMPLY AN INDICATION OF INTEREST.   


Offering Circular Selected Risks Related to this Offering | SEC EDGAR Page

Overview


Better Mental Healthcare   



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


Fisher Wallace is an R&D stage medical device company that has developed wearable brain stimulation technology that comfortably stimulates the brain to treat common mental health conditions without causing serious side effects. 


Under temporary clearance from the FDA, Fisher Wallace distributed over 100,000 proof-of-concept devices to patients via 14,000 prescribers, and is now applying for FDA approval for the treatment of depression. With the temporary clearance expiring, Fisher Wallace now has until March 1, 2024 to fulfill the requirements for premarket approval to treat depression with its new transcranial alternating current stimulation (tACS) technology. 


As part of its application, the company recently submitted the results of a 255-subject, triple-blind, randomized, controlled trial that used its fixed output device, and is in the process of submitting the results for publication in a peer-reviewed journal. The company’s previous depression research includes a pilot study conducted at Mount Sinai Beth Israel Hospital that was published in the Journal of Nervous and Mental Disease. (source)


In 2022, the company sponsored a first responder study in collaboration with the Seattle Police Department and Washington State University to improve the mental health and wellness of first responders. The results of this study, expected by Q2 2023, are intended to support scaling the company’s solution to first responder communities nationwide.


The company is nearing completion of OAK, the mass market version of its fixed output technology, in collaboration with the engineers and designers behind Beats, Nest and the Microsoft Hololens. OAK is designed to inherit any regulatory approvals or clearances that may result from our clinical research. With world-class design and scientific validation, OAK is intended to appeal to millions of people seeking a better way to improve mental health and wellness.


THE MARKET


Depression, anxiety and insomnia are at scale

*People who have depression and anxiety symptoms estimated based on 2021 survey conducted by the National Institutes of Health (source). Additional sources: CBSNIH


Nearly one-third of US adults report experiencing symptoms of depression or anxiety. (source) According to the CDC, 70 million Americans suffer from chronic sleep deprivation (source). 



THE PROBLEM


Delayed treatment effect, side effects, modest efficacy, and high administrative costs make drug therapy and behavioral therapy insufficient solutions

Antidepressants often take many weeks to be effective (source), cause a wide range of side effects, and even in generic form are expensive when the cost of doctor visits is included. 


The average cost of behavioral therapy is $100 - $200 per session (source) and as many as half of patients fail to complete the “homework” associated with 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 and effective alternatives and adjuncts.

THE SOLUTION


Self-administered technology that’s rapidly effective with minimal side effects


Our clinical trial evidence demonstrates that our technology rapidly improves depression symptoms without causing serious side effects when used daily for 20 minutes per treatment session. 77.4% of surveyed customers intend to use their Fisher Wallace device for the rest of their lives to maintain mental health and cognitive performance.

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

OUR TRACTION


Proven product-market fit and scalability



Under temporary FDA clearance, Fisher Wallace succeeded in distributing over 100,000 variable output devices through 14,000 providers and was named one of five “Health-Tech Start-Ups to Watch” by Entrepreneur magazine. 


The company’s ongoing clinical research with its new fixed output technology is designed to both obtain new FDA indications as well as enable the company to obtain insurance coverage once commercialized. Medicaid in Maine (MaineCare) was the first state Medicaid program to fully cover the purchase of Fisher Wallace’s variable output technology. 


*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 2.0 device for free!


THIS WEBPAGE 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.



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


CROWDCHECK VERIFIED REPORT 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.

ABOUT

HEADQUARTERS
630 Flushing Avenue, Box 84
Brooklyn, NY 11206

Fisher Wallace Labs makes wearable brain stimulation technology that has been prescribed by over 14,000 providers to treat mental health conditions. The company is pursuing FDA approval and building a Version 2.0 device called OAK.

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.

ALL UPDATES

03.03.23

Fisher Wallace Launches Reg A+ Offering!

Thanks to our previous crowdfunding, Fisher Wallace successfully completed and submitted the results of its pivotal depression study to the FDA to obtain approval for the treatment of Major Depressive Disorder. No wearable device has ever been approved to treat depression before, and we've launched our new campaign to preserve our first-mover status, build our first app, and finance the tooling and manufacturing process for OAK.

We've simultaneously begun conversations with venture capital firms to support our growth and will keep you apprised of any commitments on that front.

We believe that our technology should ultimately achieve smartphone-level ubiquity given the prevalence of depression, anxiety and insomnia, which impact more than half of the US population.

According to a recent survey, nearly half of our customers consider their Fisher Wallace device as important as their cell phone, and more than three quarters of our customers intend to use a Fisher Wallace device for the rest of their lives to maintain mental health and cognitive performance.

Thank you for considering becoming an early investor. Anyone who invests $1500+ in this campaign will receive a coupon code to obtain OAK for free as soon as it's released. We encourage you to watch our new campaign video to hear CEO Kelly Roman discuss the future of Fisher Wallace.

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

Tier 1

Invest $1,500+ and receive a free Fisher Wallace Version 2 Device and 2% bonus shares.

$5,000

Tier 2

Invest $5,000+ and receive a free Fisher Wallace Version 2 Device and 5% bonus shares.

$10,000

Tier 3

Free Fisher Wallace Version 2 Device and 10% bonus shares.

$25,000

Tier 4

Invest $25,000+ and receive a free Fisher Wallace Version 2 Device, 15% bonus shares.

JOIN THE DISCUSSION

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VG
Vazgen Grigoryan

2 months ago

Hi, I invested 1500+ more than month ago but still haven’t received a code. Also when v2 device will be available? Thanks

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GH
Grigore Hreniuc

13 INVESTMENTS

3 months ago

There is another company on StartEngine TruBrain. What makes you better or they have same ideas?

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RC
Ryan Cedermark

3 months ago

I invested 1500 on the last campaign and have not received an email regarding a free unit. What do i do?

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DB
Derek Bosomworth

3 months ago

Hello there! Interesting tech. What’s the cost per unit of the version 1 device and what is the planned price for the OAK device? I can’t find anywhere where you mention the differences between the old and the new device. Is the OAK device simply a market ready version? Do you have studies from your 100,000 initial users and the effectiveness of the device? Thanks!

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HOW INVESTING WORKS

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

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PREVIOUSLY CROWDFUNDED
$8,322,178.72
RAISED
$21,734.79
INVESTORS
8

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