Fisher Wallace Laboratories

Medical Devices for Mood and Sleep

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.

$2,689,285

raised
1,592
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

$2,689,285

raised
1,592
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:

$1,500+
Investment
First Volume Tier
Free Fisher Wallace Device
$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

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 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%.

Drug therapy provides low to modest efficacy with a high rate of side effects and high cost

Antidepressants, anti-anxiety and sleep medications all cause a high rate of side effects, some serious, and even in generic form are expensive when doctor visit costs are included. Behavioral therapy (psychotherapy or CBT) does not cause serious side effects but is expensive and requires a very high level of patient engagement. Neither drug therapy nor behavioral therapy have demonstrated high rates of efficacy.

FDA regulated wearable treatment - just 20 minutes per day

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.

Over 70,000 patients treated, and multiple clinical trials completed

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.

* Source

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. 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.

Patients 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%.

These testimonials may not be representative of the experience of other customers.  These testimonials are no guarantee of future performance or success.

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 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).

Our goal is to create a new standard of care for the treatment of depression, anxiety and insomnia that is broadly covered by insurance. This is why we have invested in clinical trials and are developing a Version 2.0 device with improved industrial design and an app.

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.

To become the world’s leading non-surgical electronics company for the brain - starting with a new standard of care for depression, anxiety and insomnia

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

Leaders in their field

Co-Founder and CEO Kelly Roman has helped pioneer the field of wearable neuromodulation and is an expert in product development, regulatory affairs, healthcare marketing and clinical trial strategy. Co-Founder Charles “Chip” Fisher grew up in the electronics business (his father founded Fisher Radio, later renamed Fisher Electronics) and began his career at IBM before acquiring the original patents to the Fisher Wallace device. The company’s medical advisory board is comprised of leaders in the fields of psychiatry, opioid addiction treatment and sleep medicine. Now, they’ve teamed up to disrupt the mental health industry with cutting-edge technology. 

Kelly Roman (left) and Chip Fisher (right) flank Medal of Honor recipient SFC Petry

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.


Updates

🔥Venture Capitalist Peter Rojas joins Fisher Wallace as an Advisor

3 days ago


Dear Investor,

I'm pleased to announce that Peter Rojas has formally joined Fisher Wallace as an advisor. Peter is a partner at Betaworks Ventures, a venture capital fund investing in the future of how we live, work, and play online; among other investments, Betaworks Ventures was a seed investor in Giphy (acquired by Facebook in 2020).

Prior to Betaworks Ventures, Peter was VP of Strategy at AOL and Co-director of Alpha, the company's experimental products group. He is also the co-founder of several successful startups, including Weblogs Inc. (acquired by AOL in 2005), where he created and was editor-in-chief of both Engadget and Joystiq; Gizmodo/Gawker Media (now part of G/O Media); music discovery service RCRD LBL; and gdgt, a social commerce platform (acquired by AOL in 2013).

I've known Peter for many years, and he's coming on board Fisher Wallace at a critical moment for our company - and our country - as we work to elevate the understanding and treatment of mental health.

Peter and I recorded our Zoom conversation yesterday as a means of introducing him to our tens of thousands of customers, our thousands of individual investors on StartEngine, and other stakeholders - you may watch the 25 minute exchange on Vimeo (I'll also post it as a podcast and update on StartEngine itself shortly). Warning: it was my first time recording a zoom and the camera does not switch back to who's actually speaking as regularly as it should ;)




Peter believes Fisher Wallace has the potential to become the "Peloton of mental health" - we are working to realize this potential via a combination of new FDA-Approval and re-Clearance applications, rebranding from Pearlfisher (Blue Bottle Coffee, Seedlip), Version 2.0 industrial design from Eric Fields (Beats, Nest), and new app and website development for our upcoming prescription and wellness brands.

Here are a few highlights from my Zoom with Peter:

- Peter is excited by the "end-to-end solution" approach to mental health and wellness that Fisher Wallace is currently developing, and believes "the moment is here" culturally in the US.

- Fisher Wallace is not simply a device, "it's a practice."

- In a recent survey of hundreds of Fisher Wallace customers, more than 75% of respondents declared that they intend to use their Fisher Wallace device for the rest of their lives.


As always, if you invest $1500 or more in Fisher Wallace on StartEngine, you will receive a free device (you may opt for Version 1 or Version 2, with anticipated release of Version 2 by end of Q1 2022).

Sincerely,

Kelly Roman

Cofounder and CEO, Fisher Wallace

🔥New Podcast Interview

12 days ago

Dear Investors,

We invite you to listen to the interview with our CEO Kelly Roman on the AWAKEN YOUR ALPHA podcast! Kelly opens up about his own challenges with depression when he was in his twenties and how it inspired him to build the company. Enjoy!


🎯CEO Update #1

17 days ago

Dear Investors,

Following is a general business update from Kelly Roman, Co-Founder and CEO of Fisher Wallace - the first in what will be become a weekly video update on StartEngine. Thanks for your consideration and please leave any questions in the comments section of our campaign page!


 

🎯New Article on Entrepreneur.com

19 days ago

Dear Investors,

We invite you to read a new article on Entrepreneur.com about Fisher Wallace. This is an article we sponsored as a means of educating the Entrepreneur readership about our campaign - thanks for your consideration!

3 Reasons Why Executives are Using a Medical Device to Manage Mental Health




🔥Exciting News re: Version 2.0

24 days ago

Fisher Wallace has engaged renowned industrial designer Eric Fields to design our Version 2.0 device.

Eric Fields is one of the preeminent industrial designers of the past decade - recognition for his work includes back-to-back Red Dot Awards (the highest honor for an industrial designer) for the Nest Thermostat and the Beats Pill.

We look forward to Eric bringing Version 2.0 to life in physical form, in concert with the rebranding currently underway by Pearlfisher.

By integrating world-class design, branding, clinical research conducted during the pandemic, and new FDA Approval and/or Clearance, we believe our Version 2.0 device will set a new standard of care for mental health treatment.



Best,

Kelly Roman

CEO

Featured in Entrepreneur Magazine

about 2 months ago


"5 Health-Tech Startups to Watch in 2021"

- Entrepreneur magazine

 


Dear Investor,

Entrepreneur magazine just named Fisher Wallace one of "5 Health-Tech Startups to Watch in 2021."

Thanks for your continued interest in our mission of becoming a new standard of care for depression, anxiety and insomnia.

Best regards,

Kelly Roman
CEO, Fisher Wallace Laboratories

Important FDA Update

about 2 months ago




Dear Investor,


I am pleased to report that the FDA has officially filed our depression approval application, which means the Agency has found it to be complete - the first major hurdle of the submission process. FDA reviewers will now proceed with a substantive review of the application.


"A filing review was conducted on your submission...and it was found to contain all of the information needed to proceed with the substantive review." 

Fisher Wallace has succeeded in raising over $2.2 million via our SEC-regulated equity crowdfunding campaign which sells shares in Fisher Wallace to the public. These funds allowed us to execute our three clinical trials which were submitted to FDA on March 19th, 2021, and we are now focused on Version 2 product development. I will have an additional announcement regarding product developing in the coming week.

Investors who purchase $1500 of Fisher Wallace equity are eligible to receive a free device - and may opt to receive a free Version 2 device.

Best regards,

Kelly Roman
CEO, Fisher Wallace Laboratories

New Podcast Review of the Fisher Wallace device

about 2 months ago

We invite you to listen to Andrea Samadi's review of her month-long trial with the Fisher Wallace device on her podcast, Neuroscience Meets Social and Emotional Learning. Andrea used a Fitbit to measure her sleep at baseline for 3 days before measuring the effect of the Fisher Wallace device on her sleep over the following four weeks.

The Bright Side of Life

2 months ago


We invite you to listen to The Bright Side of Life podcast interview with Fisher Wallace CEO Kelly Roman as he discusses the benefits of using the device.


Great News

3 months ago



Dear Investor,

I am pleased to announce that Fisher Wallace has signed an agreement with StartEngine to participate in StartEngine Secondary, a new investor trading platform that can match orders for buyers and sellers of Fisher Wallace securities. We will not join this platform until we close our current equity crowdfunding campaign. Listing on StartEngine Secondary may provide shareholders access to a marketplace for their shares.

I am also pleased to report that we completed our March 19th FDA submissions for all three of our indications - depression, anxiety and insomnia - in partnership with our regulatory team at Hyman, Phelps and McNamara (recently named the #1 FDA law firm by USNews and World Report).

We produced positive data from all three of our clinical trials, and I feel particularly proud of the results of our Generalized Anxiety Disorder study, in which more than 70% of subjects experienced a 50% or greater reduction in symptoms by the end of week 8. While I cannot provide any assurance that our bid for FDA Approval will succeed, I believe we are in a strong position.

There was no worse or more challenging time, operationally or societally, to conduct these trials. There was also no better time to scientifically validate a low risk, affordable, highly accessible, easy-to-use treatment for depression, anxiety and insomnia that could be prescribed via telemedicine and shipped directly to a patient’s door. The events of the past year underscored the need for an alternative to existing treatment and modalities which have failed to help many patients, and the study results demonstrated that the Fisher Wallace device could help alleviate mental health conditions.

As always, should you decide to invest $1500 or more in Fisher Wallace, you will receive a free device - you may choose to receive Circadia® or opt to receive a Version 2.0 device when it becomes available.

Thanks for your consideration,

Kelly Roman

CEO, Fisher Wallace


Disclaimer re: StartEngine Secondary: 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.

Treating a New Generation

3 months ago


Dear Investors,

We know that the impact of the pandemic - not just the virus itself but the resulting isolation and economic impacts - have taken a serious toll on the nation's metal health - especially among young people. Here's an excerpt from a recent report from The Henry J. Kaiser Family Foundation:

"Young adults have experienced a number of pandemic-related consequences, such as closures of universities and loss of income, that may contribute to poor mental health. During the pandemic, a larger than average share of young adults (ages 18-24) report symptoms of anxiety and/or depressive disorder (56%). Compared to all adults, young adults are more likely to report substance use (25% vs. 13%) and suicidal thoughts (26% vs. 11%). Prior to the pandemic, young adults were already at high risk of poor mental health and substance use disorder, though many did not receive treatment."

A few years ago, we launched a brief collaboration with the streetwear brand Mishka to address the mental health needs and cultural taste of younger consumers. This limited edition of 100 devices sold out very quickly and generated coverage in Hypebeast, but we refrained from expanding this product line until we could generate the clinical data needed to fully support the treatment.

We now have the clinical data. As Fisher Wallace pivots from completing its clinical trial submissions to focusing on Version 2 product development, we will be focused on making our solution appealing - from a hardware and app perspective - to a younger generation. Our product development process will be informed by the learnings gained from our partnership with Mishka and the heightened need for our solution in the current and post-Covid world.

Thanks for your consideration,

 


Kelly Roman

CEO, Fisher Wallace 


Our Anxiety Study Results

3 months ago

Dear Investors,

I am pleased to announce that the results of our anxiety study are strong enough for Fisher Wallace to submit them to FDA by March 19th - we believe the results will support approval for the treatment of Generalized Anxiety Disorder.

However, there can be no assurances that FDA will in fact approve our application for the proposed clinical use or accept the application for filing, or, if FDA does file the application, that the Agency will not identify deficiencies in the application that will compel us to generate additional clinical analyses or data, or provide other information to address deficiencies FDA may identify.  


I will update you again when I have information regarding our Insomnia clinical trial - our biostatistics team, NAMSA, is still processing the Fitbit data from this trial.

 

Thanks for your consideration,

 

Kelly Roman
CEO, Fisher Wallace

Our Depression Study Results

4 months ago

Dear Investors,

While I am unable to divulge detailed information regarding the results of our Major Depressive Disorder (MDD) clinical trial prior to publication by a peer-reviewed journal, I am pleased to announce that the results of the study are strong enough for Fisher Wallace to submit to FDA by March 19th and that we believe the results will support approval for the treatment of Major Depressive Disorder. However, there can be no assurances that FDA will in fact approve our application for the proposed clinical use or accept the application for filing, or, if FDA does file the application, that the Agency will not identify deficiencies in the application that will compel us to generate additional clinical analyses or data, or provide other information to address deficiencies FDA may identify.  

 

I will update you again when I have information regarding our Generalized Anxiety Disorder trial - our biostatistics team, NAMSA, is preparing this information now.

 

Thanks for your consideration,

 

Kelly Roman
CEO, Fisher Wallace


This Reg A+ offering is made available through StartEngine Primary, LLC. This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. For more information about this offering, please see the Fisher Wallace, Inc  offering circular as well as the risks associated with this offering

Fisher Wallace featured in new documentary

4 months ago

Dear Investors,


Here's a clip we obtained from the producers of the amazing new documentary entitled SLEEP AT ANY COST that will be released in the US in the coming months. This remarkable segment profiles Fisher Wallace and one of our patients who successfully treated her mood and sleep symptoms. Enjoy!


 

Thanks for your consideration,


Kelly Roman

CEO, Fisher Wallace


This Reg A+ offering is made available through StartEngine Primary, LLC. It is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment. Please review the offering circular before investing.

Update on Our Three Clinical Trials

7 months ago

Hi, I hope you are well. 


I'm pleased to announce that we have successfully recruited enough patients to fill our three clinical trials. A number of patients are still in the process of migrating from becoming eligible (through automated questionnaires) into telemedicine interviews and subsequent approval for enrollment, but we have enough patients in process to meet our enrollment goals.


As I've mentioned before, in a recent survey of 5,470 respondents performed by the CDC between April-June 2020, 30.9% of respondents reported symptoms of anxiety or depressive disorder - a 3X increase since the pandemic began. The nation is in the midst of a mental health emergency resulting from COVID-19 and Fisher Wallace is working tirelessly to scientifically validate a safe, effective, low cost solution that may be delivered directly to patients' homes. 


Thanks for your consideration!


Best regards,


Kelly Roman

CEO, Fisher Wallace

Rates of depression and anxiety have tripled during the pandemic

9 months ago

In a recent survey of 5,470 respondents performed by the Centers for Disease Control and Prevention (the "CDC") between April-June 2020, 30.9% of respondents reported symptoms of anxiety or depressive disorder - a more than 3X increase versus before the pandemic.

You may view the data here: https://www.cdc.gov/mmwr/volumes/69/wr/mm6932a1.htm

This report sheds light on the massive need Fisher Wallace is working to address - and why our current clinical trials for depression and anxiety are so critical to our mission.

Best regards,

Kelly Roman

CEO, Fisher Wallace Laboratories


This investment is speculative, illiquid, and involves a high degree of risk, including the possible loss of your entire investment.



Free Device with $1500 or more invested in our Reg A+ Campaign

9 months ago

Dear Investors,


When you invest $1500 or more in our Reg A+ campaign, you will receive a free Fisher Wallace device (our wellness brand Circadia® which is technologically identical to the Fisher Wallace Stimulator but does not require a prescription, as it is intended for stress and sleep management). We are allowed to ship your device once your investment has be disbursed to Fisher Wallace by StartEngine - this is when the investment goes from "cleared" to "invested." The first disbursement will likely occur by the end of this week, and then every two weeks thereafter.


If you invested $1500, you will soon receive an email from Fisher Wallace requesting a shipping address.


Thanks and be well!


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.

Show More Updates End of Updates

Comments ({{profileCtrl.startup.comments_count}} total)

{{profileCtrl.newComment.body.length}}/2500
Please sign in to post a comment.
Please use Updates for communications.
{{ profileCtrl.commentsLoading ? 'Loading...' : 'Show More Comments' }}