Forbes Magazine
One of 4 Technologies Innovating Mental Health
Overview
*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 problem
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
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
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
*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!
One of 4 Technologies Innovating Mental Health
5 Health-Tech Startups to Watch in 2021
Could A Shock-Delivering Headband Cure Depression?
Using Electricity, Magnets for Mental Illness
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 |
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.
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.
UNHAPPY HAPPY PEOPLE
A mental health comedy series on TikTok
Produced and directed by Kareem Rahma
Sponsored by Fisher Wallace Labs
Featuring: Kareem Rahma, Maddy Smith, Randall Otis, Neel Gosh, Chike Robinson, Nina Tarr, Joey Dardano, River Ramires, Sameer Naseem, Kelly Bachman, Johnny Gaffney, Jill Gonzales.
Watch the first clip featuring Kareem Rahma - Kareem is a force of nature on TikTok and the star of the short film OUT OF ORDER that premiered at the Tribeca Film Festival last weekend.
Follow the series to catch a fresh short every few days for the next eight weeks.
“We decided to fund a cultural event, not an ad campaign, that gives artists free rein to discuss mental health. Their views are their own, but the NYC based comedians in Unhappy Happy People share experiences that many of us will identify with - and by making us laugh, they take the power away from the taboo and give it back to us."
- Kelly Roman, CEO, Fisher Wallace Labs
Thank you investors and thank you StartEngine for making our campaign a tremendous success!
We look forward to everyone choosing their favorite color!
Dear Investor,
This is my last campaign update - our campaign will close at end of day.
I'll leave you with a quote from the The Wall Street Journal interview with Dr. Richard Brown of Columbia University, published more than 10 years ago when we were just getting the business off the ground:
Does it work? Columbia University psychiatrist Richard P. Brown says he has used the device with 400 severely depressed patients and that more than 70% find relief—about twice the rate of anti-depressants. "I'm seeing some patients smile for the first time in 20 years," says Dr. Brown, who, like other doctors interviewed for this column, has no financial ties to the company.
- The Wall Street Journal, 1/11/11
Our depression trial currently underway will hopefully provide scientific data that mirrors Dr. Brown's clinical experience - if it does, we will be in a position to annex a significant portion of the depression treatment market. If it doesn't, we still have the positive results from our anxiety trial (conducted last year) to support a new FDA indication for Generalized Anxiety Disorder - it's important to note that nearly half of depression patients suffer from clinical anxiety, which means we can address patient symptoms one way or another.
Best,
Kelly Roman
Co-Founder and CEO
Fisher Wallace Labs
Invest $1500+ to obtain a free device as a perk.
Dear Investors,
Thank you for once again pushing us over the $1 million raised milestone. Our campaign closes tomorrow, and the next few months promise to be an amazing ride:
- Our depression clinical trial is on track to complete recruitment by the end of June, allowing us to submit the data to the FDA in September, months before the December 11th deadline. If we obtain a positive outcome, we will be in a position to become the first wearable device in history to receive FDA Approval to treat Major Depressive Disorder.
- Between now and September, the FDA may render a decision on the anxiety study data we submitted last year - obtaining an indication for Generalized Anxiety Disorder would also be a first for a medical device company.
- Our pilot study with the Seattle Police Department is on track to conclude in July. We intend to leverage the data to build partnerships with other institutions and large employers and look forward to growing our new B2B channel as we scale our established B2C channel.
- Engineering of OAK (our Version 2.0 device) is on track to complete before the end of the summer, at which point we can begin the hand off to our tooling vendor.
- In June, we are launching a social media content series featuring 15 renowned New York City comedians who explore the challenges they've faced with their own mental health - a compelling, stigma-breaking, highly entertaining new approach to raising awareness. You will be the first to know when this is launched.
Achieving the above milestones will build enterprise value and cement our leadership position in a category - prescription wearables for mental health - that is in its infancy.
We are still a start-up, but a mature one - we have over $30 million in lifetime revenue, over 80,000 customers, and multiple clinical trials. Our Version 1.0 device, already on the market, faces no supply chain challenges - giving us all the time we need to get OAK into production. I would not want to be a startup trying to get off the ground today - I am glad we are in a position of strength.
Thanks again,
Kelly Roman
Co-Founder & CEO
Fisher Wallace Labs
Invest $1500+ and receive OAK for free months before it's released to the general public.
Below is the letter our CEO Kelly Roman sent to 150,000 Fisher Wallace newsletter subscribers yesterday afternoon:
Dear Customer,
My daughter turns 8 next month. We live in New York and when she came home from from school last week after hearing about the mass shooting in Buffalo, she was afraid that she was going to be shot. Millions of parents are grappling with how to ease their children's fears, so I wanted to share a tactic that I found helpful - and am likely using again today.
When she brought up the shooting my mind raced to find a way to put the real risk of her being shot in perspective, in a way that's understandable to a child. I said, "Lets look on my phone and see what the odds are of getting hit by lightning. I'm pretty sure the odds of getting hit by lightning are better than you being shot." I do my best never to lie to my daughter and I've found using facts to reduce her anxiety is effective.
With her sitting by my side, watching me scan websites for data, here's what I found to support the argument: 1) According to the National Weather Service, the chance of being hit by lightning in your lifetime if you live to 80 years of age is 1 in 15,300. 2) According to the CDC, 8 children are intentionally shot every day on average. In a nation of 73 million children, that means the odds are 1 in 25,000 of a child being intentionally shot in a given year.
In order to soothe my daughter's anxiety, I went with this data as supporting evidence, even though I knew the comparison was flawed. I then turned our attention to the Guiness Book of World Records to find the person who had been hit by lightning the most and survived each time - a park ranger by the name of Roy Sullivan was hit 7 times. My daughter found this amazing, and I joked that after getting hit three times, Roy probably thought that would be the last time...and then the fourth time came, after which he probably thought the same, and then the fifth time happened. By this point my daughter was laughing.
The more relevant facts are very different. The National Weather Service reports the chance of getting hit by lightning in a given year (as opposed to a lifetime) is 1 in 1,220,000. The chance of a person being shot in the US for any reason - adult or child, intentionally or not - is only 1 in 3000. I'll wait for a different day to share those facts with my daughter.
I selected the data points needed to make the comparison work, and in doing so I turned the fear my daughter had of being shot into a moment of laughter. I was still using facts, but in a manipulative way - arguably the best choice given the circumstances. I would not use those same data points to help reduce an adult's anxiety.
Yesterday I worked such a long day I didn't see the news until 11pm. My daughter is certainly going to hear about the school shooting sometime today while at school. I'm leaving work early so I can join my wife in picking her up from the bus stop, about 10 blocks from where we live. I'm doing that to make myself feel better - to savor the privilege of picking her up. It's a privilege a lot of parents no longer have. If you are able to pick your child up today, I recommend it - I suspect you will remember picking them up on this particular day for a long time. I know I will.
Respectfully,
Kelly Roman
CEO, Fisher Wallace Labs
View the pre-order site here.
To receive OAK for free, invest $1500+ in the remaining days of this campaign.
Allowing patients to choose the color of their depression treatment is a powerful way to uplift the treatment process and reduce stigma. A huge percentage of people with mental health symptoms never seek treatment - affordability and stigma are often to blame.
Our ultimate goal is to see the device become free for all customers through insurance - that will take time to materialize, and in the meantime we are keeping our device as affordable as possible out-of-pocket. Our partnership with the Seattle Police Department is an opportunity to demonstrate how employers will benefit by offering our technology to employees for free - improving employee performance, lowering sick days and lowering overall healthcare costs simply makes bottom-line sense.
We recently passed $1 million raised and there are 4 days left to invest. As always, invest $1500+ and receive a free Version 1 (available now) or Version 2 (available in 2023). We will start shipping Version 1 perk devices days after the campaign closes (SEC regulation demands that perk devices are only shipped after an investment has been disbursed, following the close of the campaign). Investors will receive a unique coupon code to obtain a free device through our website, which also provides a free prescription process (handled by our telemedicine partner, B2BMD).
Best regards,
Kelly Roman
Co-Founder & CEO
Fisher Wallace Labs
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
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!
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
{{ profileCtrl.commentsLoading ? 'Loading...' : 'Show More Comments' }}