Fisher Wallace Laboratories

Updates

Fisher Wallace Update - July 2020

24 days ago

Dear Investors,

Over the next two weeks, Fisher Wallace will be launching three clinical trials, one for the treatment of major depressive disorder, one for the treatment of generalized anxiety disorder, and one for the treatment of insomnia. These trials are intended to satisfy the FDA's clinical data requirements for full FDA-Approval for each indication. The current due dates for data submission to FDA are October 19th for depression (which may be extended by the agency due to the pandemic), and December 19th for anxiety and insomnia. Once we submit the data to FDA, it should take approximately a year for the agency to render an approval decision for each indication.

There are no other medical devices that are currently FDA-Approved to treat depression, anxiety and insomnia (though a few for depression alone, and at least one for insomnia alone). Fisher Wallace will be in a great position to rapidly expand market access with only one of the three approvals; with all three, we will be in an unprecedented position to drive massive adoption by patients, providers, insurance companies and employers. One can never have 100% confidence in the success of any clinical trial, as there are many variables, however I have high confidence that each will succeed, given the clinical feedback we have received to date from our 60,000+ patients and 10,000+ providers, as well as the smaller studies we've already conducted to date, such as our 2015 depression study at Mount Sinai Beth Israel hospital.

I also spoke today with Ximedica, a premier engineering, industrial design and software firm, and am strongly leaning towards them as the partner we will choose to fully develop our Version 2 device, which I expect will be released in Q1 or Q2 next year. We want to do more than make the device look better and give it a standard app. We want to leverage this unprecedented clinical hardware platform as a big piece in a larger puzzle that brings together evolving forms of telemedicine and digital health. More on this later - right now, we are laser focused on completing our clinical trials on deadline.

Our first shipment of devices from our new contract manufacturer arrived at Fisher Wallace's fulfillment center today. The massive cost savings resulting from new production will start to be realized in September (when we will be finished paying the invoices of our previous supplier). I expect to ramp up our sales via increased advertising in September.

Despite the damaged US economy, our sales have remained strong. We lost money in January - March and then returned to profitably in April. Our investments in clinical trials over the next few months will be significant, but we have the cash on hand, thanks to your investment in our Reg-CF round on StartEngine, to cover them.

I'd like to conclude today's update with a few recent testimonials from our customers who emailed us about their experience using our device during the pandemic. These underscore the true value we are providing to patients during these challenging times:

“I use my Fisher-Wallace device for treatment of depression and anxiety. During the Coronavirus quarantine, I am finding it especially helpful in dealing with anxiety. I am a healthcare worker currently working in a COVID-19 triage center. There is a great deal of risk associated with my work and this can increase my anxiety level. My Fisher-Wallace device has helped me keep my anxiety about work and being cooped up on my days off under control. I highly recommend the Fisher-Wallace device for anyone with depression and/or anxiety.”

- Julia, Indiana

“I am currently using the Fisher Wallace Stimulator daily during the lockdown for anxiety and depression. I find that it is helping me stay calm during these long days of having to stay indoors and having no human contact, as I live alone. It has kept this time bearable and I am immensely glad to have it.”

- Anonymous, New Hampshire

“I originally bought the stimulator this winter because my Seasonal Affective Disorder was particularly bad this year. and work particularly stressful. It helped immediately with my depressed mood and it also increased my energy level and anxiety. I began feeling better fairly quickly and stopped using it at the end of February because I was doing so well. Now, life has really taken quite a stressful turn. I am an ER nurse, and although my hospital has only had a handful of coronavirus cases at a time, I know that it is coming. I think it must be like waiting for a hurricane to hit your house-it's pretty terrifying! We don't feel safe in the ER, because we are told we cannot have N95s even while we are treating presumed positive cases. We only get to have that type of mask once the patient is admitted and the next MD in the chain orders the test. That's too late for us in the ER. Needless to say, I've been feeling more stressed than usual, anxiety is back and energy is dropping like a stone. I started using the device again, and it again has caused a quick improvement in all of my symptoms. I pondered a long time before buying it, but I figured if I tried an antidepressant, which may or may not work, I would be spending significantly more over a few months in co-pays than in just buying the stimulator. And if I stop using the device because I'm feeling better, there's no withdrawal unlike antidepressants-which can be AWFUL. I really recommend giving this product a try. I think you will be very pleasantly surprised. Thanks,”

- Barb, Pennsylvania

“My name is David and I've been using the stimulator for anxiety as well as insomnia. I use it twice a day. It has helped me during the lockdown to keep my anxiety in check as well as to help me sleep at night. I find it most useful when I wake up in the middle of the night and can't get back to sleep. The Fisher Wallace stimulator helps keep me centered. It also helps keep my days structured which I think is key to dealing with the uncertainty that has been going on since the Covid-19 pandemic started.”

- David, New York

“I use my Fisher Wallace stimulator twice a day to help me combat depression and insomnia. It is one of the most effective tools I have found for this purpose, and I have not had any sleepless nights since the quarantine started.”

- Michael, Washington

“My doctor suggest I try the Fisher Wallace for insomnia and anxiety. I was very reluctant to try it out and it was in my home for 2 weeks before I tried it out. The worry of the virus was making it so I could not sleep more than 3 hours at night and my anxiety was increasing by the day. I finally tried it and two weeks later I am back to a normal sleep pattern and my anxiety level is decreasing with each day of use. I am so glad that I have the fisher wallace as it has provided great relief from anxiety and insomnia for me.”

- Carol, Kansas

“I received my FW last August. I’d suffered from insomnia for years before this. I’ve used it routinely for months but am particularly glad I have it now. I find that the nights I don’t use it, I have interrupted sleep. In this situation that we find ourselves in, I have realized I need to use it every night to manage the anxiety and sadness. I’m so glad I have a reliable approach to manage all of this. It has made all the difference!”

- Patricia, Michigan

Thanks for your consideration, stay safe and be well.

Sincerely,

Kelly Roman, CEO

Investor Update

about 2 months ago

Dear Investors,

Thanks for your patience - my apologies for my delay in updating you, it's almost hard to believe how many weeks have gone by.

Fisher Wallace has performed well over the past two months, with April and May solidly profitable at a $5M run rate. Over the past three weeks, I have been focusing on setting up new clinical trials - always a challenge, but particularly now, as all institutional research sites (such as university medical centers and sleep labs) have been unable to conduct clinical trials during the pandemic. So last week we partnered with an innovative, proven clinical trial platform called ProofPilot that conducts randomized, controlled trials via telemedicine with patients at home. This approach makes sense for several reasons - not the least of which is that our technology is designed to be used at home, not in a hospital. Over the next few months, we will be conducting at least two, and possibly three, randomized, controlled clinical trials simultaneously - one for insomnia, one for generalized anxiety disorder, and possibly a third for major depressive disorder. The data will be used to obtain FDA approval and insurance coverage and will fundamentally transform our business - for the first time, we will possess large-subject clinical trial data for each of our three indications.

The vast majority of start-up medical device companies do not generate revenue until they obtain insurance coverage - as a result, they typically rely on substantial venture capital until their products are adopted by the insurance industry. Fisher Wallace is a rare medical device company for developing a unique direct-to-patient, out-of-pocket e-commerce model that has essentially served as a financial bridge for us to arrive at an insurance model. With these new clinical trials, we are finally starting to cross that bridge. When we arrive at the other side, providers and payers will have much greater confidence in our clinical value, and patients will no longer need to pay for our device out-of-pocket. Put another way, while our current revenue model has served its purpose, it's not the only model we intend to leverage.

After obtaining new clinical trial data, generating a version 2.0 device and expanding into Europe (where we are already approved for sale over-the-counter) are our next priorities. We plan to introduce a version 2.0 as early as Q1 2021. In the meantime, we'll benefit financially from our recent migration to overseas manufacturing. We will receive our first order of devices from our new contract manufacturer by early July - these new devices will have outstanding quality and through better component sourcing and PCB manufacturing, will reduce our cost of goods sold (COGS) by about 60%. If we had that COGS reduction last year, we wouldn't have lost any money. This year will be the greatest year for our business to date, and we are forecasting a healthy profit despite our investments in clinical trials and product development. I feel particularly humble writing this, given the tremendous hardships so many people are experiencing right now. The demand for mental health solutions is at an all time high.

2020 is going to be a transformative year for all of us - as a nation. I appreciate that we're in it together.

Best regards,

Kelly Roman

CEO, Fisher Wallace

🔵 Business Update

5 months ago

Dear Investors,

Last week we experienced stable revenue despite the dramatic downturn in the economy, and I attribute this to several factors: 1) while people are being directed to stay home, our device is one of the only treatment option for stress, mood and sleep that may be obtained via a telemedicine prescription (without leaving home) and without a trip to the pharmacy (as we ship the device directly to their home) 2) reducing or eliminating stress, anxiety, depression and insomnia positively impacts immune system health - a critical consideration for customers today 3) many states have waived their archaic telemedicine laws and now allow doctors to operate remotely across state lines 4) we are offering a significant "Crisis Relief Discount" on all orders 5) we've seen growing sales for our wellness brand, Circadia ®, which does not require a prescription.

By next week, we will inventory Circadia® with Amazon (where our device is currently out of stock) and direct more people to Amazon to buy it - obviously, most of America now depends on Amazon for all of their shopping needs, so this should become a growing distribution channel for Circadia® moving forward. We cannot sell the Fisher Wallace Stimulator on Amazon as Amazon is not permitted to sell prescription medical devices - this is a good thing, as it allows us to keep more margin on this brand by managing our own e-commerce and pass along savings to the customer instead of fees to Amazon.

As always, if you have friends, family members, colleagues or employees in need of stress and/or sleep management, please refer them to Circadia®, and give them an exclusive $400 discount in the process (we know these are very challenging economic times). Here’s the link that provides the $400 discount: https://circadia.info/products/circadia-399-free-ship. There’s a 100% free return / refund policy, and no prescription is required to purchase Circadia®.

I plan to update you on a week by week basis during this crisis - thanks for your consideration.

Best regards,

Kelly Roman

CEO, Fisher Wallace

BTW, from The New York Times: "A healthy immune system can fight off infection. A sleep-deprived immune system doesn’t work as well. In one surprising study, researchers found 164 men and women willing to be exposed to the cold virus. Not everyone got sick. But short sleepers — those who regularly slept less than six hours a night — were 4.2 times more likely to catch the cold compared with those who got more than seven hours of sleep, researchers found. Risk was even higher when a person slept less than five hours a night."

Business Update, $400 Product Discount, and Word-of-Mouth Request

5 months ago

Dear Investor,

I hope you and your family are healthy and secure. Getting quality sleep and reducing stress are two of the most important things you can do to improve your immune system - as recently highlighted in The New York Times.

Our technology improves sleep and reduces stress (specifically, it reduces cortisol, the stress hormone, as demonstrated in published research) - and we ship our device directly to the customer’s home, an essential convenience today. Healthcare needs to be delivered when social distancing is the new normal.

Business Update

Our factory is currently open, our supply chain is currently intact, and customers are buying devices. Last week, we launched a new 100% free returns policy. This means we now provide a free return shipping label and no longer charge any return / restocking fees. Customers can try our technology knowing that they may return it for a full refund, free of charge. We are beginning to see early signs that this policy is positively influencing short term buying decisions.

We Need Your Grassroots Support

Our wellness device, Circadia®, clones the technology of our medical device but may be obtained without a prescription, as it’s marketed for stress and sleep management (a wellness claim) as opposed to depression, anxiety and insomnia (a medical claim). In other words, Circadia® and the Fisher Wallace Stimulator® are identical hardware, producing the same output, but are labeled differently, which allows Cicadia® to be obtained without a prescription.

If you have friends, family members, colleagues or employees in need of stress and/or sleep management, please refer them to Circadia®, and give them a $400 discount in the process (we know these are very challenging economic times). Here’s the link that provides the $400 discount: https://circadia.info/products/circadia-399-free-ship

Again, there’s a 100% free return / refund policy, and no prescription is required to purchase Circadia®.

Discussing stress and sleep is a lot easier than discussing depression and anxiety, which is why Circadia® is an important product in our portfolio. It makes “word of mouth” much easier to facilitate, while providing the identical hardware as our flagship medical product.

Of course, feel free to use the discount link yourself - or buy Circadia® as a gift for someone. One great benefit of the device is that multiple people can use a single device so long as the electrode sponges are replaced regularly - great for couples, for instance, when both partners need stress and sleep management.

Please let me know if you have any comments, questions or concerns.

And remember, getting enough sleep is one of the best things you can do to stay healthy. Don’t fear the 30-90 minute nap.

Best regards,

Kelly Roman

CEO, Fisher Wallace

One day left to join our waitlist!

5 months ago

Dear Investors,

If you have not already invested in Fisher Wallace and wish to, you have one day left to join the waitlist. Waitlist investors are turned into active investors if any of the current investors are not cleared through the confirmation process, which almost always occurs with some investors.

It's wonderful to be oversubscribed, and I hope some of you will be able to join us as investors through the waitlist process!

Best,

Kelly Roman

CEO, Fisher Wallace

🔵 Thank you! We just passed $1Million in funds raised.

5 months ago

To all of our investors, thank you - because of your belief in our product and our future, we just passed $1 Million in funds raised, with 3 days left in the campaign.

I look forward to the next phase of the journey.

Much appreciated,

Kelly Roman
CEO
Fisher Wallace Laboratories

Our campaign closes in 4 days - and we are very close to $1M raised!

5 months ago

Dear Investors,

We have four days left in our campaign, and we are not extending it - thanks for your consideration. As of today, we are close to hitting the $1M mark.

As you know, our technology is drop-shipped to patients directly for us at home - a convenience of even greater value in these times for customers who wish to limit their travel to obtain treatment.

Please let me know if you have any questions!

Best,

Kelly Roman

CEO, Fisher Wallace

Last Chance to Invest

5 months ago

Dear Investors,

Fisher Wallace is closing its equity crowdfunding campaign in a few days from now. Even if you don't invest, I invite you to visit our campaign page to learn more about our mission. This is the last email we will send to request your consideration to invest - we appreciate your attention.

Compared to drug therapy, psychotherapy, TMS and ECT, Fisher Wallace offers a unique treatment option: extremely safe (almost no side effects), very effective, affordable (not yet "cheap" but well worth it if it succeeds), and convenient to use in the privacy of your own home. We know you understand the value, and hope you will support our journey as we enter the next phase of commercializing this product with better design, patient monitoring, data analytics, and most importantly, ubiquity. Once we are able to reduce the cost of the device to under $400 for most patients (achievable with manufacturing and marketing innovations) we believe this technology will supplant the standards of care that are currently covered by insurance. Thanks in advance for helping us get there!

We've valued the company at a modest $15M for this raise to incentivize participation - the market for mental health treatment in the US is enormous, more than cancer, heart disease or diabetes. Thanks again for your consideration!

Much appreciated,

Kelly Roman
CEO
Fisher Wallace Laboratories
Connect with me on LinkedIn

Treating Veterans and First Responders

5 months ago

Fisher Wallace has a long history of treating the veteran and first responder communities. Retired US Army General Stephen N. Xenakis, MD, was one of the first members of our volunteer medical advisory board and has had great success treating veterans in his private practice with our technology. Dr. Xenakis is currently assisting Fisher Wallace in setting up a first-of-its-kind clinical trial at a large military hospital.

Last month, Fisher Wallace completed a clinical trial that treated 30 active duty police officers, with results currently being prepared for publication.

As we endeavor to grow the business over the next year and beyond, we intend to leverage the data from the police study to drive adoption by police departments nationwide - there are over a million uniformed police officers in the US, many of whom are in need of safe, effective sleep and stress management tools.

We invite you to listen to retired US Marine Logan Shield and Dr. Xenakis discuss using our device to treat mood and sleep symptoms as part of our StartEngine video, as well as Vietnam Veteran Mike Davis.

We have included the biographies of Dr. Xenakis and advisory board member Dr. Meir Kryger, Yale School of Medicine, below.

Thanks for your consideration and please let us know if you have any questions.

Stephen N. Xenakis, M.D.

Dr. Xenakis served 28 years in the United States Army as a medical corps officer. He held a wide variety of assignments as a clinical psychiatrist, staff officer, and senior commander including Commanding General of the Southeast Army Regional Medical Command. Dr. Xenakis has written widely on medical ethics, military medicine, and the treatment of detainees. He has published editorials in the Washington Post and a number of other national magazines and journals, including book chapters and legal reviews. Dr. Xenakis has an active clinical and consulting practice, and is currently working on the clinical applications of quantitative electroencephalography (QEEG) to brain injury and other neurobehavioral conditions.

Meir Kryger, M.D., FRCPC

Meir Kryger, MD, FRCPC, joined the Yale School of Medicine and the VA Connecticut Health System, November 2011. Previously he was Professor of Medicine, University of Manitoba where he established the first clinical laboratory studying patients with sleep breathing problems in Canada. Dr. Kryger has published more than 200 research articles and book chapters. He is the chief editor of the most widely used textbook in sleep medicine, The Principles and Practice of Sleep Medicine, currently in its 5th edition and is the author of A Woman's Guide to Sleep Disorders, the Atlas of Clinical Sleep Medicine, and Kryger’s Sleep Medicine Review. Dr. Kryger was the first to diagnose and report obstructive sleep apnea in North America. His research was the first to show the feasibility of using noninvasive techniques to ventilate post-polio patients in their homes. His laboratory elucidated the interaction between heart failure and sleep respiration publishing the first systematic study of oxygen in this condition. He has been president of both the Canadian Sleep Society and the American Academy of Sleep Medicine. He is on the Board of Directors of the National Sleep Foundation in Washington, D.C., and served as Board. He received the William C. Dement Award for Academic Achievement in sleep medicine. In 2011 he received a Distinguished Scientist Award from the Canadian Sleep Society at the meeting of the World Association of Sleep Medicine.

Notice of Funds Disbursement

6 months ago

[The following is an automated notice from the StartEngine team].

Hello!

As you might know, Fisher Wallace Laboratories has exceeded its minimum funding goal. When a company reaches its minimum on StartEngine, it's about to begin withdrawing funds. If you invested in Fisher Wallace Laboratories be on the lookout for an email that describes more about the disbursement process.

This campaign will continue to accept investments until its indicated closing date.

Thanks for funding the future.

-StartEngine

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Company	:	Fisher Wallace Laboratories, Inc.
Corporate Address	:	515 Madison Avenue, New York, NY 10022
Offering Minimum	:	$10,000.00
Offering Maximum	:	$1,070,000.00
Minimum Investment Amount (per investor)	:	$250.00

Offering Type	:	Equity
Security Name	:	Class B Non-Voting Stock
Minimum Number of Shares Offered	:	4,000
Maximum Number of Shares Offered	:	428,000
Price per Share	:	$2.50
Pre-Money Valuation	:	$15,000,000.00