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