Fisher Wallace offering is now closed and is no longer accepting investments.
INVEST IN FISHER WALLACE TODAY!
Prescription Wearables For Mental Health
$1,268,563.21 Raised
REASONS TO INVEST
Recently completed and obtained strong results from a pivotal clinical trial to apply for FDA Approval for the treatment of Major Depressive Disorder.
The Seattle, Salt Lake City, and Nashville Police Departments are using the company’s technology to improve employee mental health and wellness.
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
WEBSITE
View Site
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
Co-Founder, CEO, and Director
Charles "Chip" Fisher
Co-Founder & Chairman & Director
Simon Webster
Board Member
Peter Rojas
Advisor
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
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.
Stack Owner's Bonus & Rewards!
Members get an extra 10% shares in addition to rewards below!
REWARDS
$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
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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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REWARDS
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SECURE
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With Regulation A+, a non-accredited investor can only invest a maximum of 10% of their annual income or 10% of their net worth per year, whichever is greater. There are no restrictions for accredited investors.
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