Fist Assist Devices, LLC

Invest With the Multi-Family Real Estate Professionals of Redwood Real Estate Fund
$ 0
Raised
0
Investors

$250,000

Target
Offering

$500.00

Minimum
Investment

$10M

Valuation

$1,000,000

Maximum
Offering

$1.00

Unit
Price

1,000,000

Available
Units

Offering Ends December 31, 2022

$ 0
Raised
0
Investors

$250,000

Target Offering

$500.00

Minimum Investment

$1,000,000

Maximum Offering

$1.00

Share Price

$10,000,000

Valuation

Offering Ends December 31, 2022

Why Invest?

  • Novel Massager with an FDA authorization

  • Focal Massager to Decrease Arm Pain

  • Medical Device to Increase Focal Arm Circulation

  • Circulation is the “river of life” and provides timely medical care

Fist Assist Devices, LLC Mission

To develop world’s first, novel, innovative, wearable devices that:
  • Improve arm circulation for arm wellness with a focal massager
  • Support patients through their medical care journeys by improving arm circulation
  • Enhance global population arm health within approved regulatory pathways
– Dr. Tej Singh, Founder

The Offering:

The Fist Assist Model FA-1 Device is a self-contained, battery-operated, wearable, focal intermittent pneumatic compression device. The small control unit is integrally attached to an inflatable cuff that is held to the upper extremity. Patients are able to apply and remove the Device themselves. All pressure and timing parameters are preset at the factory. The bladder is inflated to a pressure of 60 mmHg and held for 20 seconds then deflated to 10 mm Hg pressure for 55 seconds before the next inflation. 

The Device uses this intermittent compression to enhance arm circulation by altering changes in wall shear stress, wall tensile stress, and through nitric oxide release.

The Fist Assist Model FA-1 is a CE Mark cleared device for vein dilation in the European Union. It is FDA cleared as a wearable massager that can increase arm blood circulation and help relieve arm pain. Recently, the Device was granted FDA Breakthrough Device designation as indicated for pre-surgical vein dilation for AV fistula creation in adult patients diagnosed with chronic renal failure when assessed with inadequate vein size.

Published Clinical Papers

  • Early Application of an Intermittent Pneumatic Compression Device is Safe and Results in Proximal Arteriovenous Fistula Enlargement – Journal of Vascular Access, May 2018
  • Early Application of an Intermittent Pneumatic Compression Device Assists Dilation of Radiocephalic Fistulas – Journal of Vascular Access, August 2018
  • A New Approach to Vein and Arteriovenous Fistula Dilation – Journal of Kidney Care, March 2020
  • The FACT: Use of a Novel Intermittent Pneumatic Compression Device to Promote Pre-Surgery Arm Vein Dilation in Patients with Chronic Renal Failure – Journal of Vascular Access, November 2021

Use of Proceeds

The proceeds from this offering will be used for for:

  • Initiation of a global marketing, education and commercialization campaign in not only the United States but also Australia, New Zealand, Europe, and Japan.
  • Completion of FDA/regulatory clearances to expand indications for use for distribution of the Device in the United States and globally.
  • Offering, accounting, legal fees and costs

Use of proceeds if the offering’s maximum amount of $1,00,000 is raised:

46.8%

Global Marketing

$468,000

20.4%

Regulatory / Quality

$204,000

18.7%

General and Administrative

$187,000

11.1%

Legal / Finance / Contingency

$111,000

3%

Intermediary Fees

$30,000

Fist Assist Devices is creating novel wearable devices focusing on increased arm circulation. Circulation is the “river of life” and better arm circulation will serve as the foundation for pain control, improved recovery, and arm preparation for timely medical care. Increased arm circulation is an important medical need globally!

About Us:

Fist Assist Devices, LLC, is an embodiment of the life work of Tej M. Singh, M.D., M.B.A. Dr. Singh’s interest in arterial and vein dilation for many medical conditions started when he was a medical student at the University of Chicago from 1989 to 1993 and he was exposed to patients with vascular access difficulties. Dr. Singh observed that End Stage Renal Disease (ESRD) patients require large veins and effective functioning arm fistulas for eventual hemodialysis and intravenous (IV) access. However, there are significant costs, poor outcomes, and poor patient experiences when fistulas do not develop and veins do not enlarge, leaving patients with no control over or hope for the best outcomes for their individual medical care.

Dr. Singh always believed that there must be a better way to prepare veins for not only hemodialysis but also for any clinical indication calling for increased vein size and enhanced circulation. Based on this early interest, for his entire adult life Dr. Singh has pondered ways to develop medical devices that take the concepts of basic, exercise, and physical science into consideration to advance clinical care.

Patents

Realizing the need for a device to assist in arm vein care and dilation for many disease states, Dr. Singh designed a unique intermittent pressure device and in 2008 submitted his first Fist Assist patent application to the United States Patent and Trademark Office (the “USPTO”). This was followed by further device development and testing, including production of a successful prototype of the world’s first pneumatic compression device intended to provide patients in need of arm vein dilation with a non-invasive, external alternative to accomplishing vein dilation clinical goals.

Dr Singh never rested: he continued to develop and improve the device. 

Today, Dr. Singh is the Inventor on three patents issued by the USPTO and one USPTO patent pending as well as one international Patent Cooperation Treaty (PCT) normalization of Dr. Singh’s third issued patent and one pending PCT application for the pending USPTO patent application. Dr. Singh has granted exclusive commercialization rights to the Company for all of the issued patents and patents pending under an exclusive Intellectual Property License Agreement. The patents and patent pending are described in chronological order as follows:

Patent # Patent Name Date Filed Date Granted Geographic Area
8231558
Application No. 13/540,549
Hemodialysis Vein Preparation
3/17/08
7/31/12
USA
8905953
Application No. 13/540,549
Hemodialysis Vein Preparation
7/2/12
12/9/14
USA
10939920
Application No. 15/866,748
Hemodialysis Vein Preparation Method
1/10/18
3/9/21
USA / Intl.
20210252206
Application No. 17/196,750
Restricting Steal for AV access
3/9/21
Pending
Pending
PCT/US2019/013008
Based on U.S. Patent No. 10,939,920
Hemodialysis Vein Preparation Method
1/10/19
Foreign applications filed in
* Canada (Patent No. 3,088,297);
* Europe (Patent App. 19738629.5);
* India (Patent App. 202017033998) and
* Japan (Patent App. 2020-558860)
PCT/US2019/013008
Based on U.S. Patent No. 10,939,920
Restricting Steal for AV access
Pending
3/4/22
Foreign “nationalization” not yet due.

Hrishikesh Gadagkar, PhD

Regulatory Consultant

Partners

According to the United States Centers for Disease Control and Prevention (CDC), total Medicare fee for service spending for patients with ESRD or kidney failure reached $37.3 billion in 2019 or $86,400 per person, which is approximately 7% of all Medicare paid claims costs.

Regulation CF FAQ:

For Non-Accredited Investors (most fall into this category) the limitation on how much you can invest depends on your net worth and annual income.

If either your annual income or your net worth is less than $107,000, then during any 12-month period, you can invest up to the greater of either $2,200 or 5% of the greater of your annual income or net worth.

If both your annual income and your net worth are equal to or more than $107,000, then during any 12-month period, you can invest up to 10% of annual income or net worth, whichever is greater, but not to exceed $107,000.

  • After you review the offering statement and information and decide you’d like to invest and how much, you complete the application with the requested information and electronically sign the documentation.
  • Rialto Markets, the Broker Dealer, reviews the information for Anti-Money Laundering and Know Your Customer type reviews
    • If you pass the review, Rialto initiates the funds via ACH or Credit Card (or you send the wire or check if applicable)
    • If you don’t pass the review, Rialto or the Issuer will reach out to you to update information to clear you for the reviews or otherwise
  • Once the funds have been cleared by the escrow agent (funds go directly there), Rialto will match your funds with your cleared application for investment, and issue you the stock by validating the subscription agreement and notifying the Transfer Agent to record your ownership on the Issuers capitalization table.

The timeline is generally 2 to 4 weeks but can always happen sooner. It all depends on the information you provide and if there are issues, how quickly we hear back from you.

  • If we bump up against any “hits” on our reviews, we are required to clear each one of those potential conflicts to evidence there are no issues.
  • If the information provided is not correct or is incomplete, we will need to reach out and get this corrected.
  • Even though funds are initiated or you see them pending in your funding source, this does not mean they are in the escrow account for the offering. Based on the payment rails available in the US, these funds may not appear in escrow for 1-2 days and then they have to sit there for a few days until the escrow agent is satisfied there doesn’t
    appear to be any issues
  • Matching of payments to approved applications happens in batches, so while all ready to be closed, your application maybe in the next batch.
Rialto Markets LLC is the FINRA/SEC registered Broker Dealer who has been engaged by the Issuer to act as the Onboarding Agent for this offering.
  • Rialto Markets LLC is NOT placing or selling these securities on behalf of the Issuer.
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By investing in an Issuer’s Reg CF offering where Rialto Markets is the Broker Dealer Onboarding Agent, Rialto must ensure that you as the investor, do not breach the SEC’s limits on investing in Reg CF Offerings within a 12 month period. While it’s not a full-fledged brokerage account where we custody your holdings or recommend any investments, you will have an account at Rialto to track the investments made where Rialto was engaged as the Broker Dealer
Onboarding Agent.

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Applying investors with questions about the company or its product or the offering should submit their questions in the Discussion section of the investment website. This is a public forum where valid questions will be displayed for all to view, with responses clearly tagged with who the response is from (i.e., the Issuer, Rialto Markets).
An accredited investor, in the context of a natural person, includes anyone who:
  • earned income that exceeded $200,000 (or $300,000 together with a spouse or spousal equivalent) in each of the prior two years, and reasonably expects the same for the current year, OR
  • has a net worth over $1 million, either alone or together with a spouse or spousal equivalent (excluding the value of the person’s primary residence), OR
  • holds in good standing a Series 7, 65 or 82 license.
Any questions about the application, how to navigate it, what’s the process, etc. should be directed to Rialto Markets using the contact information provided at the bottom of the investment website.

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