Dear Investors,

We invite you to listen to Fisher Wallace Labs co-founder and CEO Kelly Roman as he discusses mental healthcare and startup strategy with Steven Loeb, host of the Vator News Podcast - a leading podcast in the healthtech space. The interview took place last week and is now streaming.

Our "flash crowdfunding campaign" ends in less than 3 weeks, with capital going towards research and development of OAK - with a shot at becoming the first FDA-Approved wearable for depression. The FDA submission deadline is December 11 and our pivotal clinical trial is on schedule for a data lock in October. 

Invest $1500+ and receive a coupon code to obtain OAK in 2023 or our Version 1 device (Fisher Wallace Stimulator) immediately after the campaign closes - as a free perk.

Best regards,

Fisher Wallace Labs

Insomnia research Fisher Wallace conducted during the pandemic in 2020

Sleep medication is considered efficacious if it increases total sleep time by 20 minutes. Fisher Wallace conducted its most recent insomnia study during the height of the pandemic in 2020, when patients were in lockdown. The device increased total sleep time in active device participants by 26 minutes per night on average, whereas participants using a placebo device experienced a decrease in total sleep time of 16 minutes (untreated sleep worsened during the pandemic) - a difference between active and placebo of 42 minutes. These results were submitted to the FDA in March 2021 to obtain FDA re-clearance for the treatment of insomnia.

Starting a Personal Sleep Study

Patients use the device nightly for 20 minutes before going to sleep and may use a sleep tracker (Fitbit, Apple Watch) to obtain quantifiable proof of effectiveness (if you don't have a sleep tracker, you may write down the time you wake up each morning, if you typically wake up before an alarm).

The device is cleared by the FDA to treat both anxiety and insomnia, and this is important for patients who need better quality sleep: reducing anxiety before attempting sleep will often reduce the time it takes to fall asleep. Sleep trackers will record this data as well.

We invite you to listen to a short podcast created by a journalist who shared the sleep tracking data she recorded during her 30-day trial of the Fisher Wallace device.

Bottom line: Patients need only give the device 1 - 2 weeks to dramatically improve sleep, and may return it for a full refund if it's not a game changer. Only 15% of our customers return their device.

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

The campaign will close in 21 days.

Unlocking The Brain's Potential

Your brain determines exactly how you feel and sleep - and its ability to rapidly change, electrochemically, is truly remarkable.

Since 2007, Fisher Wallace has been a medical device company that specializes in harnessing the brain's electrochemical system to eliminate the symptoms of depression, anxiety and insomnia.

Our FDA-Cleared technology works by comfortably stimulating the brain for 20 minutes per session to produce serotonin and other neurotransmitters required for healthy mood and sleep, while also lowering cortisol and modulating the center brain regions responsible for the sympathetic nervous system (the "fight or flight" response).

The majority of patients achieve significant symptom reduction or remission within the first two weeks of use - without experiencing side effects.

A Convenient Self-Care Routine

Patients use the device for 20 minutes after waking up, and again for 20 minutes before going to bed. You may engage in your regular morning and evening activities while using the device - whether that's having a cup of coffee or watching TV.

When you experience rapid results, starting and ending each day with a brain stimulation session quickly becomes an enjoyable routine.

40% of our customers also report improvements in focus, concentration and memory - another benefit of consistently stimulating the brain.76% of our customers report that they intend to use the device for the rest of their lives to maintain mental health and cognitive performance.

Trusted by First Responders

Our device is currently being used by the Seattle Police Department, including by 911 dispatchers, to improve mental health and wellbeing. More departments are joining the pilot program. Over the prior decade, we have supported thousands of US military veterans and their family members by treating the common symptoms of post traumatic stress. Customers may obtain our device today at the same discounted price that we apply to large institutions.

Multiple Clinical Trials

We've performed 6 clinical trials, including a safety study with pediatric patients, a study at Phoenix House (substance use patients), and a bipolar depression study conducted at Mount Sinai Beth Israel Hospital. With over 1000 participants in our trials and approximately 85,000+ devices sold to patients through 14,000 providers, our technology is established as a safe and effective treatment option.

Patients only keep the device if it works for them.

Talk therapy and drug therapy are not refundable, despite half of patients not finding relief. No mental health treatment works for 100% of patients, which is why offer a 30-day full refund policy, with free return shipping. Less than 15% of our customers return their device for a refund.

We prioritize affordability out-of-pocket, as few insurance providers cover mental health treatment devices. The purchase is FSA / HSA eligible. No-interest payment plans are also offered during checkout.

Fisher Wallace provides respectful, easy-to-reach customer service - available by phone, chat and email seven days a week from 10am - 10pm EST.

Reviewed by Elle Magazine

"But since I couldn't stop talking about my good mood and hypercharged focus, my friends stopped laughing and started asking if they could borrow it. I'm reluctant to let go of my stimulator, however."

- Nina Burleigh, ELLE Magazine

OAK will arrive in 2023

A collaboration between Fisher Wallace, Alloy Product Development (Beats, HoloLens) and Eric Fields (Beats, Nest), OAK uses a new design vocabulary intended to integrate brain stimulation technology into the lives of millions of people. 

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

The campaign will close in 23 days.

Dear Investors,

The Early Bird Bonus 5% bonus shares) ends tomorrow, and may be stacked with other bonuses and perks.

"But since I couldn't stop talking about my good mood and hypercharged focus, my friends stopped laughing and started asking if they could borrow it. I'm reluctant to let go of my stimulator, however."

- Nina Burleigh, ELLE Magazine

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

Fisher Wallace Labs

Dear Investor,

Any CEO running a for-profit healthcare business should feel a fundamental level of discomfort in profiting off people who are simply trying to heal themselves.

Given the small number and size of research grants available through the NIH, the vast majority of medical device startups must raise capital for R&D by selling shares to investors who expect a return on their investment.

If Fisher Wallace can succeed in obtaining broad insurance coverage - one of the goals of our current depression clinical trial - our device will become free to many patients, and the price we charge insurance companies will be a fraction of the cost of talk therapy or generic drug therapy (when doctor visits to monitor dosage are included) over the course of a year. If we can dramatically lower the cost of providing mental healthcare (and reduce the number of patients with mental health issues who, as a population, consume far more healthcare services than those who don’t), will that ultimately lower the cost of insurance? I certainly hope so - it should.

The NIH grant process has too long a timeline (relative to our FDA submission deadlines) and does not yield initial grants large enough to cover the costs of large scale clinical trials required to obtain FDA Approval. The millions of dollars needed to engineer and manufacture a world-class device like OAK is simply not available from the government. We therefore must continue raising capital from investors in order to do so.

Fisher Wallace is modestly profitable on device sales when R&D expenses are excluded - when only the cost of advertising, manufacturing and overhead is deducted. In 2023, we intend to release our first mobile app that will offer talk therapy, allowing us to build a recurring revenue business by offering additional services to our customers. In order to spend money on research and product development, we must raise it.

Our customers know our technology works, and they have become the backbone of our R&D financing through StartEngine by buying shares in Fisher Wallace. If we achieve our goals over the next 12 months - a depression trial that obtains FDA-Approval, the launch of OAK, and insurance coverage expansion - we will be in a position to lead the wearable brain stimulation market for years to come. I believe next year's products and services will ultimately appeal to tens of millions of users.

It’s challenging to align the incentives of a for-profit healthcare business with the needs of patients. I think Fisher Wallace is doing the best job it possibly can to ensure everyone wins.

Best regards,

Kelly Roman

Co-Founder & CEO

Fisher Wallace Labs

EARLY BIRD BONUS ENDING SOON

INVEST $1500+ FOR A FREE VERSION 1 OR VERSION 2 DEVICE

THIS IS A 30-DAY CAMPAIGN

FREE DEVICE WITH $1500+ INVESTMENT

STACK BONUSES TODAY!

Our OAK pre-order page (currently sold out): https://www.fisherwallace.com/pages/oak

Leave a comment with any questions -our CEO will respond within 48 hours.

Thanks for your consideration! Only 27 days remain and early bird bonuses end very soon!

Dear Investors, 

Our "flash equity crowdfunding campaign" launched 2 days ago and is only live for 30 days. With 28 days left, our Super Early Bird Bonus ends tomorrow. Here's recap of the current perks / bonuses and when they expire:

• Super Early Bird Bonus: 10% Bonus Shares, Ends 72 Hours After Launch, IN ADDITION to any other bonuses (ends tomorrow)

• StartEngine Owner's Bonus: 10% Bonus Shares, IN ADDITION to any other bonuses (continuous)

• $1500+ Investment: Free Version 1 device (ships after close of campaign) or Version 2 device (ships in 2023) IN ADDITION to any other bonuses (continuous)

• $5000+ Investment: 5% Bonus Shares + Free Version 1 or Version 2 device, IN ADDITION to any other bonuses (continuous)

• $10,000+ Investment: 10% Bonus Shares + Free Version 1 or Version 2 device, IN ADDITION to any other bonuses (continuous)

• $25,000+ Investment: 15% Bonus Shares + Free Version 1 or Version 2 device + 30-minute Zoom with CEO, IN ADDITION to any other bonuses (continuous)

Thanks for your consideration!

BONUS SHARES FOR INVESTING THIS WEEK, FOR RE-INVESTING AND FOR STARTENGINE'S OWN INVESTORS (BONUSES MAY BE COMBINED) 

INVEST $1500+ TO OBTAIN A DEVICE FOR FREE

Dear Investor,

Fisher Wallace has largely pioneered the prescription wearable category for mental health over the past decade.

Over the past few months, tech behemoths such as Apple and Amazon have continued to move more aggressively into healthcare - note Amazon's planned purchase of One Medical for $3.9 billion.

Fisher Wallace has been investing in clinical research and product development to establish market position and momentum in our category - market position and momentum in a new category is something that big tech companies can't create overnight regardless of resources, and tend to acquire.

As Jeff Bezos said about Amazon's acquisition of Ring several years ago: “To be clear, my view here is that we’re buying market position — not technology,” Bezos wrote in an email thread four months before the company acquired Ring. “And that market position and momentum is very valuable.”

There are currently no wearable devices that are fully FDA-Approved to treat depression. We are two months away from completing our pivotal depression trial that will be submitted to FDA to obtain approval for the treatment of moderate to severe Major Depressive Disorder.

If we obtain FDA-Approval, we have the option of launching OAK either a prescription device for depression or as a prescription-strength wellness device, while keeping our Version 1 device (Fisher Wallace Stimulator) on the market as a discounted prescription-only device that is designed to obtain full insurance coverage (so Version 1 can become free to patients). Obtaining insurance coverage is another reason why we are investing aggressively in clinical research.

We've been simultaneously investing in OAK product development for over a year, which has often cost more than $250K a month (between engineering, industrial design and firmware development). Developing a world-class wearable device - with the designers and engineers of Beats, Nest and the Microsoft HoloLens - takes time regardless of scale and we will complete engineering of the prototype this year and finally enter the manufacturing phase. Recent supply chain challenges - most notably for Bluetooth chips - has made new hardware development for startups extremely difficult, and we are lucky that our Version 1 device (Fisher Wallace Stimulator), which doesn't use Bluetooth, faces no supply chain challenges. As a result, we've been able to scale sales of Version 1 over the past few months (graph above). By the time we release OAK commercially (Summer 2023), the supply chain disruptions should be largely a thing of the past.

In short, we are moving aggressively to transform our business from a startup success into large enterprise - we believe OAK, with its appealing design and new FDA Approval / Clearances (should we obtain them), will be something that tens of millions of users could adopt.

There are great perks for early, repeat investors that start to go away after this week!

Best Regards,

Dear Investor,

Our new equity crowdfunding campaign just launched, with perks for early investors and repeat investors. This short campaign closes in 30 days.

We raised nearly $7 million in our previous three campaigns on StartEngine to fund OAK product development and clinical research (to obtain new FDA Approval). VC firm SHUFL Capital has also invested a total of $2.75 million.

OAK is designed to make our technology appealing to tens of millions of potential users - a massive project that will wrap up the majority of the engineering this year.

Recent news: July was the highest grossing month in our history with $853K in net sales - this equates to a $10M+ annual run rate (ARR), a major milestone for any startup!

Thank you for your consideration!

Kelly Roman

Co-Founder & CEO
Fisher Wallace Labs

P.S. If you already reserved shares over the past month, please make sure to confirm your investment through the email you will receive from StartEngine today!