Fisher Wallace Laboratories
Medical Devices for Mood and Sleep
Brooklyn, NY
Health Tech
Fisher Wallace is a leading non-surgical electronics company for the brain. Our first product, the Fisher Wallace Stimulator®, is FDA-Cleared to treat depression, anxiety and insomnia. The device has been used by over 70,000 patients and is currently undergoing review by the FDA for new Approval and Clearance.
$3,281,534
raised
1,965
Investors
$40M
Valuation
$6.21
Price per Share
$496.80
Min. Investment
Common
Shares Offered
Equity
Offering Type
$10.4M
Offering Max
Reg A+
Offering
Rewards
Get rewarded for investing more into Fisher Wallace Laboratories:
$2,500+
Investment
Second Volume Tier
Free Fisher Wallace Device and 2% bonus shares
$5,000+
Investment
Third Volume Tier
Free Fisher Wallace Device and 3% bonus shares
$10,000+
Investment
Fourth Volume Tier
Free Fisher Wallace Device and 4% bonus shares
REASONS TO INVEST
Traction
Over 70,000 patients and 10,000 prescribers in the United States, with over $23.3M in lifetime revenue
Clear Path to FDA Approval
Three clinical trials were submitted to the FDA on March 19, 2021 to support new approval and clearance; over-the-counter approval has been obtained in Europe, and Medicaid has approved the device in Maine (MaineCare)
Previous Crowdfunding Success
Raised over $1M in an oversubscribed Reg CF raise from over 1400+ investors
THE MARKET
As a result of the pandemic, the rate of depression and anxiety among US adults has skyrocketed to 31%
(source)
-
Mental Health is the #1 healthcare cost in the US, greater than cancer, diabetes or heart disease - half of all costs are spent treating depression and anxiety (source)
-
1 in 4 Americans also develop insomnia each year
-
Spending is expected to continue growing, especially as demand grows as a result of the pandemic
The CDC Reports Highly Elevated Rates of Mental Health Conditions;
THE PROBLEM
Drug therapy provides low to modest efficacy with a high rate of side effects and high costs. Neither drug therapy nor behavioral therapy have demonstrated high rates of efficacy.
THE SOLUTION
FDA regulated wearable treatment
The Fisher Wallace Stimulator® comfortably stimulates the brain to produce serotonin and modulate brainwave activity. The device has demonstrated a high effectiveness rate and less than a 1% side effect rate (temporary headache or dizziness) in clinical practice. In a depression study conducted at Mount Sinai Beth Israel Hospital in 2015, patients who used a placebo device returned to baseline while patients who used an active (fully functioning) device experienced durable depression symptom reduction.
HOW IT WORKS
Symptom reduction in the first week for most patients
Patients may obtain a telemedicine prescription for the device which is then shipped directly to their home. They use the device for 20 minutes, one or twice a day, and typically experience symptom reduction within the first week of use. A 392-subject study conducted at a Phoenix House drug and alcohol rehabilitation facility demonstrated that the device increased rehab retention by 50%.
This has been an effective model for treating mental health during the COVID-19 pandemic - and for patients in general who cannot easily access mental health treatment or are resistant to drug or behavioral therapy.
HOW WE ARE DIFFERENT
The first hardware category to effectively compete with drug therapy for the treatment of depression, anxiety and insomnia
Our affordable medical device is easy to use, causes minimal side effects, may be prescribed remotely and shipped directly to a patient’s home.
This offers significant clinical and economic advantages over medication and behavioral therapy while also working well in conjunction with these standards of care (many providers prescribe the Fisher Wallace device in combination with medication and behavioral therapy).
THE BUSINESS MODEL
Expanding from out-of-pocket to broad insurance coverage
We currently leverage online advertising and email marketing to drive patients and doctors to our e-commerce website, where we educate them about our technology. Upon receiving a prescription, we ship the device directly to the patient, who typically purchases the device out-of-pocket. We offer a 100% free return and full refund policy.
We are now focusing on obtaining FDA Approval and broad insurance coverage for our technology - to ultimately make our device free to patients and allow us to scale the business more effectively.
OUR TRACTION
Successes and Completions
Fisher Wallace has demonstrated product-market fit by selling over 70,000 medical devices through 10,000 licensed healthcare providers in the United States. The company has executed multiple randomized, controlled clinical trials which have been submitted to the FDA and is in the process of developing a Version 2.0 device with improved industrial design and an app.
Success since our last raise:
-
The FDA defined our approval path on December 19, 2019, requiring Fisher Wallace to conduct three clinical trials (one each for depression, anxiety and insomnia).
- Fisher Wallace submitted clinical trial results to FDA on March 19, 2021 to obtain new FDA Approval and Clearance, as well as expanded insurance coverage.
-
Fisher Wallace successfully migrated its manufacturing to a high-volume facility that has reduced its cost of goods sold (COGS) by 60%.
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Fisher Wallace was named one of the "5 Health-Tech startups to watch in 2021" by Entrepreneur Magazine.
* Source
THE VISION
To become the world’s leading non-surgical electronics company for the brain
Following the completion of our clinical trials, Fisher Wallace has turned its focus to commercializing a Version 2.0 device that will feature improved industrial design, data analytics and digital health services relevant to patients, providers and payers. Our goal is to create a true mental health hardware platform that seamlessly integrates into the rapidly evolving digital health ecosystem.
*This is a computer rendering of a product currently in development
OUR TEAM
Leaders in their field
Kelly Roman (left) and Chip Fisher (right) flank Medal of Honor recipient SFC Petry
WHY INVEST
A clear path to new FDA Approval and Clearance for the treatment of depression, anxiety and insomnia
Obtaining new FDA Approval for one or more indication - depression, anxiety or insomnia - will help establish a new standard of care that can serve millions of patients.
AN OFFERING STATEMENT REGARDING THIS OFFERING HAS BEEN FILED WITH THE SEC. THE SEC HAS QUALIFIED THAT OFFERING STATEMENT, WHICH ONLY MEANS THAT THE COMPANY MAY MAKE SALES OF THE SECURITIES DESCRIBED BY THE OFFERING STATEMENT. IT DOES NOT MEAN THAT THE SEC HAS APPROVED, PASSED UPON THE MERITS OR PASSED UPON THE ACCURACY OR COMPLETENESS OF THE INFORMATION IN THE OFFERING STATEMENT.
THE OFFERING CIRCULAR THAT IS PART OF THAT OFFERING STATEMENT CAN BE FOUND HERE.
THE OFFERING MATERIALS MAY CONTAIN FORWARD-LOOKING STATEMENTS AND INFORMATION RELATING TO, AMONG OTHER THINGS, THE COMPANY, ITS BUSINESS PLAN AND STRATEGY, AND ITS INDUSTRY. THESE FORWARD-LOOKING STATEMENTS ARE BASED ON THE BELIEFS OF, ASSUMPTIONS MADE BY, AND INFORMATION CURRENTLY AVAILABLE TO THE COMPANY’S MANAGEMENT. WHEN USED IN THE OFFERING MATERIALS, THE WORDS “ESTIMATE,” “PROJECT,” “BELIEVE,” “ANTICIPATE,” “INTEND,” “EXPECT” AND SIMILAR EXPRESSIONS ARE INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS, WHICH CONSTITUTE FORWARD LOOKING STATEMENTS. THESE STATEMENTS REFLECT MANAGEMENT’S CURRENT VIEWS WITH RESPECT TO FUTURE EVENTS AND ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT COULD CAUSE THE COMPANY’S ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE CONTAINED IN THE FORWARD-LOOKING STATEMENTS. INVESTORS ARE CAUTIONED NOT TO PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH SPEAK ONLY AS OF THE DATE ON WHICH THEY ARE MADE. THE COMPANY DOES NOT UNDERTAKE ANY OBLIGATION TO REVISE OR UPDATE THESE FORWARD-LOOKING STATEMENTS TO REFLECT EVENTS OR CIRCUMSTANCES AFTER SUCH DATE OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.
WHILE THE COMPANY HAS SIGNED A QUOTATION AGREEMENT TO TRADE THE SECURITIES OFFERED ON STARTENGINE SECONDARY’S NEW ALTERNATIVE TRADING SYSTEM (THE “ATS”), A COMPANY WHICH INTENDS TO BE QUOTED ON THE MARKETPLACE WILL BE SUBJECT TO CERTAIN REQUIREMENTS WHICH THE COMPANY MAY OR MAY NOT BE ABLE TO SATISFY IN A TIMELY MANNER. EVEN IF A COMPANY IS QUALIFIED TO QUOTE ITS SECURITIES ON THE MARKET, THERE IS NO GUARANTEE AN ACTIVE TRADING MARKET FOR THE SECURITIES WILL EVER DEVELOP, OR IF DEVELOPED, BE MAINTAINED. YOU SHOULD ASSUME THAT YOU MAY NOT BE ABLE TO LIQUIDATE YOUR INVESTMENT FOR SOME TIME OR BE ABLE TO PLEDGE THESE SHARES AS COLLATERAL.
Insert Horizontal Line
Updates
🎯BUILDING WHAT APPLE SHOULD BE BUILDING
2 days ago39 Days Remain Until We Close Our Campaign
(Version 2 concept above)
Dear Investors,
Apple and the other large tech behemoths have so far avoided diving into medical devices because of the complexities and risks of running clinical trials and navigating the FDA regulatory process - it's outside of their current wheelhouse. But their shareholders' demands for growth remain relentless - sooner or later, these companies will likely focus much more on this space. They have already more than dipped their toe into healthcare - whether Apple's HealthKit, Google's acquisition of Fitbit or Amazon's acquisition of PillPack.
Our Version 2 device is going to look like something Apple might build in terms of design quality, build and user experience - but with our own unique brand DNA. That's why we are working with Eric Fields, the industrial designer behind Beats and Nest products, and Pearlfisher, one of world's leading branding firms - to take our hardware to a level not seen before in prescription medical devices.
Compared to Apple, we are a microscopic company - but we are still doing something, with your support, they should be doing, with a level of design and clinical and scientific validation that is truly world-class.
We are closing our campaign in a few weeks. If you invest $1500+ you will be eligible to receive Version 2 (or Version 1) for free.
Thanks for your consideration,
Kelly Roman
Cofounder & CEO, Fisher Wallace Laboratories
This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.
🎯 OVER $3.2 MILLION RAISED
5 days ago
We just surpassed $3.2M raised in our current Reg A+, bringing our total to over $4.2M raised between our previous Reg CF and our current campaign.
Successfully raising this amount is a profound competitive advantage - none of our direct competitors have raised significant capital, and as a result, we are leap frogging them with our clinical research and Version 2 product development.
<46 DAY REMAIN UNTIL WE CLOSE OUR CAMPAIGN
Our technology is FDA-Cleared to treat anxiety, depression and insomnia - invest $1500+ and receive a free Version 1 once your investment is disbursed or Version 2 when it's released next year.
Best regards,
Kelly Roman
Cofounder & CEO, Fisher Wallace Laboratories
This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.
⭕ REASONS TO INVEST
9 days ago
<49 Days Remain
We are closing our equity crowdfunding campaign on October 26, 2021. If you invest $1500+ you will receive our Version 2 (or Version 1) device for free.
Reasons to invest:
- Experienced leadership team
- 3 Clinical trials completed during the pandemic
- Version 2 from the designer of Beats and Nest products (Eric Fields)
- Version 2 branding by Pearlfisher
- Free prescription process integrated with checkout
- Mental health treatment is the #1 healthcare expense in the US (more than cancer, diabetes or heart disease)
This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.
🎯MEDIA COVERAGE OF FISHER WALLACE
12 days ago
Mental Health is the #1 healthcare expense in the US and rates of anxiety, depression and insomnia have surged during the pandemic. Fisher Wallace is helping to lead a revolution in improving patient care at home.
"5 Health-Tech Startups to Watch in 2021"
- Entrepreneur Magazine
"Columbia University Associate Clinical Professor of Psychiatry 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."
– The Wall Street Journal
"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."
- ELLE Magazine
"One of four technologies innovating mental health."
- Forbes
Disclaimer: This testimonial may not be representative of the experience of other customers and is no guarantee of future performance or success.
In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion
🎯 Our New Prescription Process is off to a Strong Start
18 days ago
Dear Investors,
We launched our new prescription process last week which allows customers to be screened and receive a prescription if they qualify for free (to them) directly during the checkout process. We had two minor kinks we ironed out over the past few days, such as the need to pass along the full state name instead of the state's abbreviation to our telemedicine partner, but otherwise there have been no major technical hiccups.
Sales are healthy and appear to validate the transition to a fully integrated prescription process - but it will take a month or so to get a clear picture of the true impact on our e-commerce conversion rate. Thanks to our telemedicine partner, B2BMD, we now have a truly modern e-commerce experience for a prescription product - which as far as I know is unique among medical device companies.
There are a lot of wellness devices and apps out there - but very few FDA-regulated, prescription products for mental health outside of generic drugs which have many disadvantages. I've always believed that our opportunity was not to succumb to the temptation of building a slick wellness brand with flimsy scientific claims, but to focus on the prescription product space that can actually make strong medical claims, and investing in the required clinical trials before we even started to redesign how our product looked. Now that we have the clinical trial data - thanks to our StartEngine investors - and our new prescription process in place, we are moving full steam ahead on Version 2 and I can't wait to share more images as they become available. Science first! Good looks second!
Our campaign is closing in <55 days. As always, if you invest $1500 or more, you are eligible to receive a free Version 2 device.
Best, Kelly
CEO Fisher Wallace
This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.
🎯WE WILL BE CLOSING OUR CAMPAIGN SOON
20 days ago
Dear Investor,
Having successfully raised over $3 million while hitting a number of other key milestones over the past year, I've decided it's the right time to wind down our current equity crowdfunding campaign - we will keep the campaign active for 60 more days, and close it on 10/26/21.
Fisher Wallace will have the option of launching a new campaign at a later date at a higher valuation, and we may also choose to list Fisher Wallace on StartEngine's Secondary marketplace where shares may be traded.
As you can see from the image above, Version 2 product development is well underway; we have successfully completed three clinical trials over the past year, with a particularly strong result in our anxiety trial; we've launched a new study with a major metropolitan police department; we've integrated a free prescription process directly into our checkout; we've hired great new talent on the marketing and operations side of our business.
This Fall, we will move into the engineering phase of product development, start developing the mobile app and our new website, and complete the Version 2 branding process (with a new brand name which we've trademarked and I'll announce in a formal press release early next year).
I will continue to keep you updated on our progress. As always, if you decide to invest $1500+ in Fisher Wallace, you are eligible to receive our Version 2 device for free. We have raised capital successfully in large part because our loyal customers decided to support our growth and the future of our technology - and for that I feel tremendous gratitude.
Sincerely,
Kelly Roman
CEO, Fisher Wallace
This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
In addition, as described in the Offering Circular, the Company retains the right to continue the offering beyond the Termination Date, in its sole discretion.
While the company has signed a quotation agreement to trade the securities offered on StartEngine Secondary’s new alternative trading system (the “ATS”), a company which intends to be quoted on the marketplace will be subject to certain requirements which the company may or may not be able to satisfy in a timely manner. Even if a company is qualified to quote its securities on the market, there is no guarantee an active trading market for the securities will ever develop, or if developed, be maintained. You should assume that you may not be able to liquidate your investment for some time or be able to pledge these shares as collateral.
⭕ OUR FREE PRESCRIPTION PROCESS IS NOW LIVE
25 days ago
Dear Investors,
After months of preparation, our telemedicine partnership is now live on fisherwallace.com - our customers may now obtain a prescription during checkout at no additional cost.
Fully integrating a state-by-state, asynchronous and synchronous telemedicine process directly into our checkout is a major milestone for Fisher Wallace - it brings increased efficiency to the purchase process and is highly scaleable. We no longer need to ask patients to leave our website to obtain a prescription (at additional cost to them). The cost of the prescription is now bundled into the cost of the device. This allows us to scale our marketing efforts with much greater confidence - to improve Version 1 sales now and set the stage for a successful Version 2 launch next year.
Best regards,
Kelly Roman
CEO, Fisher Wallace Laboratories
⭕ Our ELLE Magazine Review
about 1 month ago
"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
Read the article here.
As always, when you invest $1500+ in Fisher Wallace, you will receive a free device.
Disclaimer: This testimonial may not be representative of the experience of other customers and is no guarantee of future performance or success. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
⭕ CEO UPDATE
about 1 month ago
Dear Investors,
As you can see, the first t-shirt arrived. As mentioned previously, we are in the process of submitting data to scientific journals so additional details will be forthcoming upon publication - but we're still having some early fun here celebrating our clinical trial results over at the Laboratory.
Here are a few key updates:
- The telemedicine service that will become a seamless part of the checkout process on fisherwallace.com is undergoing final API integration today and should be live next week. This allows for our customers to obtain a prescription from a third party provider licensed in their state without having to leave the checkout process (similar to Hims&Hers). That should increase our e-commerce conversion rate and provide a much better customer experience.
- We have submitted our new Version 2.0 brand name (still confidential), generated in collaboration with branding firm Pearlfisher, to the US Patent and Trademark Office (as well as in various European markets). It's a single syllable word that truly captures the essence of the brand and mission of the company. Pearlfisher is now diving into creating the logo, iconography, tag line, overall messaging for our marketing materials, and other branding assets.
- Industrial design on Version 2 is nearing completion of Phase 1, which means we are close to a final form factor concept which is wireless, features an integrated cell phone speaker (to provide audio cues to the user such as when the treatment session is complete, or if there are any conductivity issues requiring re-wetting the electrode sponges, etc), LED lighting, Bluetooth and, perhaps best of all, the ability to be offered in several color choices. In short, this will be a device people will be delighted to put on and even wear in public, and should greatly reduce any fear generated by seeing a red and black wire.
- Mechanical and electrical engineering workflows are now beginning, based on this evolved design concept - engineering will actually cost significantly more than industrial design, but we are working with a firm that has engineered many well known wearables to ensure world-class performance, fit and finish.
Thanks for your consideration, and as always, if you invest $1500 or more in our campaign, you are entitled to receive either a free Version 1 device (shipped within 4 weeks of your investment) or reserve a free Version 2 device. At this point our Version 2 ship date looks like it will be April at the earliest, and more likely May 2022. I'll keep you apprised of this as development continues.
Best regards
Kelly Roman
CEO, Fisher Wallace
This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.
🔴 THE COVID MENTAL HEALTH BATTLE CONTINUES
about 1 month ago
Given the stunning trend for Generalized Anxiety Disorder (GAD) prevalence pre-Covid v. post-Covid, we are expecting another surge in GAD as a result of the Delta (and possible Lambda) variant.
Delta variant cases are skyrocketing in many US geographies. Published research on GAD prevalence pre v. post COVID show an enormous uptick prior to Delta:
Generalized Anxiety Disorder (GAD) affected 3.1% of US adults prior to the COVID-19 pandemic, with only 43.2% of these patients actually receiving treatment (https://adaa.org/
Our most successful clinical trial conducted during the pandemic studied GAD. We do not welcome the mental health impacts of rising Delta variant COVID cases - however our tech is on the front line of treating patients in the midst of this new stressor. We welcome our ability to treat patients.
PS: A video update on real time business results will be posted before end of week by our CEO, Kelly Roman.
Onwards and upwards.
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