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Invest ≥ $113: Receive 100% Bonus Shares

  • Invest ≥ $1,491.60 to receive a Coupon Code for OAK (only for investors who have not previously received this perk, see terms and conditions)

COMPLETE INVESTMENT

Share Price: $11.30
(Includes 3.5% processing fee)

Minimum Investment: $101.70

Offering Circular | FORM C | Investor Education


 

Company Summary

Fisher Wallace validated its wearable brain stimulation technology as one of the most rapid treatments for anxiety and depression, with study results recently published in The Journal of Clinical Psychiatry. The company is now pursuing regulatory approval to bring its new wearable, called OAK, to market next year. Designed in collaboration with the teams behind Beats and Nest, OAK transforms treatment into a delightful consumer experience.

Co-Founder and CEO Kelly Roman has helped pioneer the wearable brain stimulation category since 2009, and is advised by Dr. Maurizio Fava, Psychiatrist-in-Chief of Massachusetts General Hospital, and Dr. David Shulkin, the former US Secretary of Veterans Affairs. With world-class scientific evidence and vibrant design that appeals to younger generations, OAK is intended to become the first FDA approved device to achieve smartphone scale.

Company Updates

  • We’re nearing completion of our FDA Clearance application (for anxiety), and our Breakthrough Device Designation application (for depression, citing the results of our clinical trial published in The Journal of Clinical Psychiatry).
     
  • We’re preparing a pivotal trial with advisor Dr. Maurizio Fava (Psychiatrist-in-Chief at Massachusetts General Hospital) to obtain FDA approval for the treatment of depression.
     
  • We recently submitted a ≈$2.5 million grant proposal to the NIH for the study of insomnia treatment in patients with Mild Cognitive Impairment.
     
  • We’re developing VA distribution with the help of our advisor Dr. David Shulkin (former US Secretary of Veterans Affairs) and expect to launch a pilot study in a VA medical center next year.
     
  • Our successful anxiety study results are being drafted for publication by the Seattle Police Department and Washington State University.
     
  • We are in the process of raising up to $12M in venture capital to fund the commercialization of OAK (equity crowdfunding is intended to serve as a bridge to venture funding).
     


 

No Other Wearable Works Faster

Our technology has been validated as the most rapid self-administered treatment for depression and anxiety.

citation



 

Designed for New Generations

Gen Alpha and Gen Z exhibit the highest prevalence of depression and anxiety, and adopt new technology more rapidly than older generations.

citation
citation



 

A Superdevice for Mental Health and Wellness

OAK is proven to treat depression and anxiety, but its ability to improve cognitive function – enabling people to think clearly – will appeal to an even broader consumer base. Our next clinical trial will measure improvements in cognitive and physical health, in addition to participants’ mood.


 

For Veterans and First Responders

Dr. David Shulkin, the former US Secretary of Veterans Affairs and CEO of Beth Israel Medical Center, recently joined Fisher Wallace as an advisor to help guide our VA distribution and reimbursement strategy.

The breakthrough results of our Seattle Police Department anxiety study, as well as our published depression study results, will support our efforts to gain VA adoption and help us scale treatment to the more than 4 million First Responders in the US. If you are a First Responder and would like to recommend our technology for a pilot program with your organization, please contact us.


 

We Proved Product-Market-Fit

Under temporary FDA clearance, Fisher Wallace commercialized its proof-of-concept Version 1.0 device and began making mental health history:

  • 100K units sold
  • 14K prescribers
  • $40M in revenue
  • Medicaid reimbursement (MaineCare)

We expect as many as 60K Version 1.0 customers to upgrade to OAK upon its commercial release.



 

Clear Path to Approval

We remain on a clear path to bring OAK to market next year in the US for the treatment or management of anxiety, and for the treatment of depression the following year. In Europe, we are applying for CE Marks for the treatment of anxiety and depression, using the data we’ve already obtained.



 

Frequently asked questions

1. Why invest in startups?

Regulation CF allows investors to invest in startups and early-growth companies. This is different from helping a company raise money on Kickstarter; with Regulation CF Offerings, you aren’t buying products or merchandise – you are buying a piece of a company and helping it grow.

2. How much can I invest?

Accredited investors can invest as much as they want. But if you are NOT an accredited investor, your investment limit depends on either your annual income or net worth, whichever is greater. If the number is less than $124,000, you can only invest 5% of it. If both are greater than $124,000 then your investment limit is 10%.

3. How do I calculate my net worth?

To calculate your net worth, just add up all of your assets and subtract all of your liabilities (excluding the value of the person’s primary residence). The resulting sum is your net worth.

4. What are the tax implications of an equity crowdfunding investment?

We cannot give tax advice, and we encourage you to talk with your accountant or tax advisor before making an investment.

5. Who can invest in a Regulation CF Offering?

Individuals over 18 years of age can invest.

6. What do I need to know about early-stage investing? Are these investments risky?

There will always be some risk involved when investing in a startup or small business. And the earlier you get in the more risk that is usually present. If a young company goes out of business, your ownership interest could lose all value. You may have limited voting power to direct the company due to dilution over time. You may also have to wait about five to seven years (if ever) for an exit via acquisition, IPO, etc. Because early-stage companies are still in the process of perfecting their products, services, and business model, nothing is guaranteed. That’s why startups should only be part of a more balanced, overall investment portfolio.

7. When will I get my investment back?

The Common Stock (the “Shares”) of Fisher Wallace Laboratories (the “Company”) are not publicly-traded. As a result, the shares cannot be easily traded or sold. As an investor in a private company, you typically look to receive a return on your investment under the following scenarios: The Company gets acquired by another company. The Company goes public (makes an initial public offering). In those instances, you receive your pro-rata share of the distributions that occur, in the case of acquisition, or you can sell your shares on an exchange. These are both considered long-term exits, taking approximately 5-10 years (and often longer) to see the possibility for an exit. It can sometimes take years to build companies. Sometimes there will not be any return, as a result of business failure.

8. Can I sell my shares?

Shares sold via Regulation Crowdfunding offerings have a one-year lockup period before those shares can be sold under certain conditions.

9. Exceptions to limitations on selling shares during the one-year lockup period:

In the event of death, divorce, or similar circumstance, shares can be transferred to:
• The company that issued the securities
• An accredited investor
• A family member (child, stepchild, grandchild, parent, stepparent, grandparent, spouse or equivalent, sibling, mother-in-law, father-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law, including adoptive relationships)

10. What happens if a company does not reach their funding target?

If a company does not reach their minimum funding target, all funds will be returned to the investors after the close of the offering.

11. How can I learn more about a company’s offering?

All available disclosure information can be found on the offering pages for our Regulation Crowdfunding offering.

12. What if I change my mind about investing?

You can cancel your investment at any time, for any reason, until 48 hours prior to a closing occurring. If you’ve already funded your investment and your funds are in escrow, your funds will be promptly refunded to you upon cancellation. To submit a request to cancel your investment please email: info@dealmakersecurities.com

13. How do I keep up with how the company is doing?

At a minimum, the company will be filing with the SEC and posting on it’s website an annual report, along with certified financial statements. Those should be available 120 days after the fiscal year end. If the company meets a reporting exception, or eventually has to file more reported information to the SEC, the reporting described above may end. If these reports end, you may not continually have current financial information about the company.

14. What relationship does the company have with DealMaker Securities?

Once an offering ends, the company may continue its relationship with DealMaker Securities for additional offerings in the future. DealMaker Securities’ affiliates may also provide ongoing services to the company. There is no guarantee any services will continue after the offering ends.



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Contact Us

Fisher Wallace Laboratories
630 Flushing Avenue, Suite 104
Brooklyn, NY 11206

Phone: 800.692.4380
Email: investors@fisherwallace.com


PERK RELATED DISCLAIMER:

Perks will be calculated for each investor based on the total investment amount. If an investor invests multiple times in this Offering, the combined amount of signed and completed investments will determine what perks the investor receives. If a new investor makes two or more investments in this Offering, the investor will qualify for Existing Investor perks for each subsequent investment after its first signed and completed investment. Perks will be calculated and assigned to investors after this Offering is completed. See FN 3 below for more information regarding the qualification to receive an OAK® coupon.

We are completing the proof of design (prototyping) phase for OAK® (Version 2 Device) and are seeking FDA clearance required for commercial distribution, and expect to commence manufacturing and distribute investigational devices for usability testing, confirmatory testing, and pilot studies in 2025, prior to commercially distributing the device under regulatory approval; there may be design and production delays which delay manufacturing or distribution. In addition, we may not successfully complete the design and manufacturing or obtain necessary FDA clearance or approvals for the product, in which case the device may never be delivered. We, therefore, assign no value to this coupon.

Only investors that have not previously qualified to receive an OAK® coupon in a prior offering shall qualify to receive an OAK® coupon for a total investment amount of at least $1,491.60 in this Offering. Only one OAK® coupon will be granted per investor, regardless of how many investments an investor makes in this Offering.

Days 1-7 include the day this offering is launched (the “Launch Date”) through 11:59:59 pm Eastern Daylight Time (“EDT”) (03:59:59 am Coordinated Universal Time (“UTC”) on the 7th day following the Launch Date (October 3, 2024). Days 8-21 commence at 12:00 am EDT (04:00 am UTC on the 8th day following the Launch Date, and ends at 11:59:59 pm EDT (07:00 pm UTC) on the 21st day following the Launch Date (October 17, 2024).

There is no guarantee that OAK will be manufactured or that regulatory permission (such as FDA approval or clearance) that may be required to distribute OAK commercially will be granted. At the current time, there are neuromodulation devices intended for wellness that are commercially available without a prescription and are not regulated as medical devices, however the regulatory and prescription requirements for such devices may change. Regulatory permission to distribute OAK may not be granted, and if it is granted, a prescription may be required to obtain OAK.

OFFERING DISCLAIMER:

Equity crowdfunding investments in private placements, and start-up investments in particular, are speculative and involve a high degree of risk and those investors who cannot afford to lose their entire investment should not invest in start-ups. Companies seeking startup investment through equity crowdfunding tend to be in earlier stages of development and their business model, products and services may not yet be fully developed, operational or tested in the public marketplace. There is no guarantee that the stated valuation and other terms are accurate or in agreement with the market or industry valuations. Any past performance described is not indicative of future results. Further, investors may receive illiquid and/or restricted stock that may be subject to holding period requirements and/or liquidity concerns.

DealMaker Securities LLC, a registered broker-dealer, and member of http://www.finra.org/ | http://www.sipc.org/, located at 4000 Eagle Point Corporate Drive, Suite 124, Birmingham, AL 35242., is the Intermediary for this offering and is not an affiliate of or connected with the Issuer. Please check our background on FINRA's https://brokercheck.finra.org/firm/summary/315324.

DealMaker Securities LLC does not make investment recommendations.

DealMaker Securities LLC is NOT placing or selling these securities on behalf of the Issuer.

DealMaker Securities LLC is NOT soliciting this investment or making any recommendations by collecting, reviewing, and processing an Investor's documentation for this investment.

DealMaker Securities LLC conducts Anti-Money Laundering, Identity and Bad Actor Disqualification reviews of the Issuer, and confirms they are a registered business in good standing.

DealMaker Securities LLC is NOT vetting or approving the information provided by the Issuer or the Issuer itself.

Contact information is provided for Investors to make inquiries and requests to DealMaker Securities LLC regarding Regulation CF in general, or the status of such investor’s submitted documentation, specifically. DealMaker Securities LLC may direct Investors to specific sections of the Offering Circular to locate information or answers to their inquiry but does not opine or provide guidance on issuer related matters.

This website contains forward-looking statements. These statements may include the words “believe”, “expect”, “anticipate”, “intend”, “plan”, “estimate”, “project”, “will”, “may”, “targeting” and similar expressions as well as statements other than statements of historical facts including, without limitation, those regarding the financial position, business strategy, plans, targets and objectives of the management of Fisher Wallace (the "Company") for future operations (including development plans and objectives). Such forward-looking statements involve known and unknown risks, uncertainties and other important factors which may affect the Company's ability to implement and achieve the economic and monetary policies, budgetary plans, fiscal guidelines and other development benchmarks set out in such forward-looking statements and which may cause actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Company's present and future policies and plans and the environment in which the Company will operate in the future. Furthermore, certain forward-looking statements are based on assumptions or future events which may not prove to be accurate, and no reliance whatsoever should be placed on any forward-looking statements in this presentation. The forward-looking statements in this website speak only as of the date of the Company's initial Form C, and the Company expressly disclaims to the fullest extent permitted by law any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. This expectation is subject to risks including market competition, technological changes, and consumer preferences that could affect actual results. Past performance is not indicative of future results.