Prescription Wearables For Mental Health

INVEST IN FISHER WALLACE TODAY!

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.
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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

REASONS TO INVEST

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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

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.

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.

TERMS

Fisher Wallace
Overview
PRICE PER SHARE
$8.81
DEADLINE
Dec 24, 2022
VALUATION
$81.57M
AMOUNT RAISED
$334,543.52
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

11.30.22

THE DEPRESSION PLAYING FIELD

Dear Investors,

FDA Approval for a depression treatment is a rare occurrence, and one of the most notable recent approvals was granted to an esketamine nasal spray. The product is arguably the most rapid depression treatment on the market with approximately half of patients responding to treatment in the first week. By Week 4, 69.3% of subjects in the Active arm had a clinical response, compared to 52% of subjects in the Control (placebo) arm, according to a recent study. The various adverse events associated with the drug are reported here.

The results of our recent depression study are comparable with esketamine in regards to rapidity and our Week 4 response rate. Oral antidepressant medication can take up to 12 weeks to be effective. Our technology causes far fewer side effects than any depression medication.

Analysts have forecast that the esketamine product would generate $3 billion in peak sales. The treatment costs several thousand dollars per patient and is administered in a clinic or doctor's office - currently required for dispensing the controlled substance. Our Version 2.0 product, OAK, will be significantly more affordable, and is designed for home use.

I look forward to the publication of our depression trial results next year, and appreciate your interest in our technology and our mission. Our campaign is closing soon.

Best regards,

Kelly Roman

Co-Founder and CEO

Fisher Wallace Labs

11.29.22

CAMPAIGN CLOSING SOON!


Dear Investor,

Our  campaign will end soon and mark the beginning of the most exciting phase of our business since we founded the company 15 years ago.

Before the end of next week we will submit the results of our pivotal depression trial to the FDA in order to obtain FDA-Approval for the treatment of Major Depressive Disorder. While we cannot guarantee success, we believe the results of the study are more than sufficient to show that our technology effectively and rapidly treats depression without causing serious side effects. This comparison of benefit and risk is at the heart of the FDA's review process.

While many devices are FDA-Cleared, there currently is no wearable device that is FDA-Approved to treat depression - teams of people inside and outside the company have been working relentlessly for years to make our technology the first.

If we succeed, FDA-Approval could occur just a few months before we launch OAK, our Version 2.0 device that will inherit any new approval. We believe the combination of world-class design and the highest level of regulatory and scientific validation will allow Fisher Wallace to truly evolve how depression is treated in the US and around the world. In short, we are building a better, safer, and faster standard of care.

To date we have raised over $7 million on StartEngine, the leading SEC-regulated equity crowdfunding platform. We've offered a number of amazing investor perks including bonus shares and a free Version 1 or Version 2 device - thank you for considering to become an early investor!

Sincerely,

Kelly Roman
Co-Founder and CEO
Fisher Wallace Labs



11.16.22

AN UPDATE FROM OUR CEO, KELLY ROMAN, ON OUR DEPRESSION STUDY


Fisher Wallace was founded over 13 years ago, and this is one of the most exciting moments in our company’s history. The path to FDA approval is ahead of us. Listen to this update from our CEO, Kelly Roman, as he talks about why our most recent study is so groundbreaking.


Repeat investors receive an additional 5% bonus and StartEngine owners receive an additional 10% bonus.

You will receive a promo code to obtain our Version 1 or Version 2 device (OAK) for free when you invest $1500+ in this campaign.



11.14.22

WHY WE ARE MOVING FORWARD WITH CONFIDENCE

Listen to Kelly Roman, Fisher Wallace CEO, explain the key results of our pivotal depression study, and why we're moving forward with confidence into the next steps of FDA approval.

We are moving forward confidently into the next steps of the FDA submission process.  


Repeat investors receive an additional 5% bonus and StartEngine owners receive an additional 10% bonus.

You will receive a promo code to obtain our Version 1 or Version 2 device (OAK) for free when you invest $1500+ in this campaign.

 

11.11.22

LOGAN'S STORY


Dear Customers, Friends and Colleagues,

My father served in the US Army during the Korean War. For his generation, struggling with mental health was not something you talked about or sought help to overcome.

Fortunately that's not the case today, thanks to veterans who have raised awareness. No single mental health solution is perfect for everyone, but I'm thankful that US Marine Logan Shield has been so generous in sharing his story, and that our technology worked for him.

Thanks for your consideration,

Kelly Roman
Co-Founder & CEO
Fisher Wallace Labs


Repeat investors receive an additional 5% bonus and StartEngine owners receive an additional 10% bonus.

You will receive a promo code to obtain our Version 1 or Version 2 device (OAK) for free when you invest $1500+ in this campaign.

11.10.22

CORRECTION: TODAY'S WEBINAR REGISTRATION LINK


Don't miss your chance to attend today's webinar about our pivotal depression trial results.

Due to the need for confidentiality prior to journal publication, Kelly cannot discuss every detail of the study results but will try to cover all your questions. 


Set a reminder if you want to join, and we hope to see you there!

Webinar Date: 11/10/2022
Time: 4PM Eastern/ 1PM Pacific
Register Here  


Repeat investors receive an additional 5% bonus and StartEngine owners receive an additional 10% bonus.

You will receive a promo code to obtain our Version 1 or Version 2 device (OAK) for free when you invest $1500+ in this campaign.

11.09.22

LAST CHANCE TO REGISTER: JOIN OUR WEBINAR, ALL ABOUT OUR CLINICAL TRIAL RESULTS


 

Want to hear more about the results of our pivotal depression study?


 Join our webinar tomorrow to hear Kelly Roman, CEO of Fisher Wallace, discuss some of the key wins from the clinical trial, such as:
• a statistically significant separation between active and placebo groups.
• a high and rapid response rate.
• lack of significant adverse events reported by participants.


Due to the need for confidentiality prior to journal publication, Kelly cannot discuss every detail of the study results but will try to cover all your questions. 


Set a reminder if you want to join, and we hope to see you there!

Webinar Date: 11/10/2022
Time: 4PM Eastern/ 1PM Pacific

Register Here  


Repeat investors receive an additional 5% bonus and StartEngine owners receive an additional 10% bonus.

You will receive a promo code to obtain our Version 1 or Version 2 device (OAK) for free when you invest $1500+ in this campaign.

11.08.22

SAVE THE DATE — KELLY ROMAN, CEO, DISCUSSES OUR PIVOTAL DEPRESSION STUDY RESULTS

The results are in!

You will have the opportunity to ask Kelly questions about the results and our plans moving forward. Due to the need for confidentiality prior to journal publication, Kelly cannot discuss every detail of the study results but can do so generally. Join the webinar on Wednesday, 11/10/2022 at 4PM Eastern Time/1PM Pacific.


Set a reminder if you want to join, and we hope to see you there!

Webinar Date: 11/10/2022
Time: 4PM Eastern/ 1PM Pacific

Register Here

11.07.22

OUR STUDY RESULTS ARE IN!

Dear Investors,

The top-line results of our pivotal depression study recently arrived from our contract research organization, NAMSA. Based on the initial review of the data, I can confirm that the study yielded statistically significant separation between active and placebo groups, as well as a high and rapid response rate, and no significant adverse events were reported by participants. In short, we believe the results clearly demonstrate that the device provides more potential benefit than risk when used to treat Major Depressive Disorder. 

We have submitted the confidential evidence of the study results to the StartEngine compliance team and are in the process of updating our campaign page to reflect the news.

It will take three or four weeks for NAMSA to generate a clinical study report, and our regulatory law firm, HPM, will submit this report to the FDA before the December 11th, 2022 submission deadline to support FDA approval for the treatment of Major Depressive Disorder.

As part of its review process, the FDA must also inspect our contract manufacturer and determine if it meets the agency’s Quality Management System Regulation requirements, as well as review Fisher Wallace’s internal Quality Management System. These activities will take several months to complete. We do not expect the FDA’s review process to result in disapproval, but we also cannot guarantee success.

The FDA is aware that there is a mental health crisis in the United States. In 2020, over 48 million Americans were prescribed antidepressant medication. If we are successful in obtaining FDA approval for the treatment of Major Depressive Disorder, we will be well-positioned to obtain insurance reimbursement, bring OAK to market with the highest level of regulatory and scientific validation, and scale our solution to millions of patients.

We are now moving forward with high confidence.

Best regards,

Kelly Roman

Co-Founder & CEO

Fisher Wallace Labs


Repeat investors receive an additional 5% bonus and StartEngine owners receive an additional 10% bonus.

You will receive a promo code to obtain our Version 1 or Version 2 device (OAK) for free when you invest $1500+ in this campaign.


11.01.22

FISHER WALLACE - BEST YEAR TO DATE

It’s official, 2022 has become the highest grossing year on record for Fisher Wallace since our company's founding.

Not only have we achieved a record-breaking revenue with two months still left in the year, but we are expecting our pivotal depression study results very shortly, and are getting ready to launch our groundbreaking version 2.0 device, OAK, in 2023.

Now is your chance to invest and be part of the mental healthcare revolution.


Repeat investors receive an additional 5% bonus and StartEngine owners receive an additional 10% bonus.

Receive a promo code to obtain our Version 1 or Version 2 device for free when you invest $1500+ in this campaign.










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













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

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