U.S. Securities and Exchange Commission

Washington, D.C. 20549

 


 

FORM 8-K

 


 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED) October 24, 2019

 

Commission File No. 001-33718

 

U.S. STEM CELL, INC.

 (Name of small business issuer as specified in its charter)

 

Florida

65-0945967

State of Incorporation  

IRS Employer Identification No.

    

1560 Sawgrass Corporate Pkwy 4th Floor, Sunrise, FL 33323

(Address of principal executive offices)

 

 13794 NW 4th Street, Suite 212, Sunrise, Florida 33325

(Former name, former address and former fiscal year, if changed since last report)

 

(954) 835-1500

(Issuer’s telephone number)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

 Common Stock

 USRM

OTC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1934 (§240.12b-2 of this chapter)

 

Emerging growth company ☐.

 

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

Unless otherwise indicated or the context otherwise requires, all references in this Form 8-K to “we,” “us,” “our,” “our company,” or the “Company” refer to U.S. Stem Cell, Inc. and its subsidiaries.

 

Item 1.01– Entry Into A Material Definitive Agreement

 

See Item 2.01.

 

Item  2.01 – Acquisition Or Disposition Of Assets.

 

On September 27, 2019, the Company reported that, as a consequence of the U.S. Department of Justice filed an injunctive action, specifically United States of America v. U.S. Stem Clinic, LLC, U.S. Stem Cell, Inc., Kristin C. Comella, and Theodore Gradel, and specifically the Court’s various orders including the Order of June 3, 2019  that the defendants (including the Company) “not sell, provide or otherwise engage in any SVF therapy or any other activities to be regulated by the FDA as explained in the Court’s Order on the Parties’ Motions for Summary Judgment” (the “Court Order”), the Company divested itself of certain equipment and other assets.

 

In conjunction with that divesture of certain equipment and other assets used in connection with the Company’s human tissue banking business, and to adjust the business plan and operations to accommodate this divesture, the Company entered into the following additional agreements:

 

 

Assignment and Assumption of Lease by and between the Company, American Cell Technology, LLC, and Sawgrass Business Plaza, LLC, dated October 24, 2019

 

The foregoing agreements are qualified in their entirety by reference to such documents, which are attached as Exhibits hereto.

  

Along with diversifying the portfolio of products distributed by the Company, including equipment and biologics, it is the intention of the Company to both continue to adhere to the Court Order as well as to work to re -establish its good standing with the Agency (FDA). These points are not mutually exclusive nor negotiable and we believe that there are still  business and patient goodness opportunities while still abiding by all legal requirements.  As a result, the Company shall be continuing with the development of  US Stem Cell Training, Inc. , an operating division of our company, that  is a content developer of regenerative medicine/cell therapy informational and training materials for physicians and patients and complies with both requirements--as well as Vet biologics, an operating division of our company, that  is a veterinary regenerative medicine company committed to providing veterinarians with the ability to deliver the highest quality regenerative medicine therapies to dogs, cats and horses. In addition, our company is transitioning the current clinics to a more diversified regenerative medicine platform, while complying with recent court rulings. While not providing legal advice, the Company may also engage in managing third-party clinics to ensure they too abide by recent regulatory requirements

 

Item 9.01– Financial Statements and Exhibits.

 

Exhibit Number

Description

10.1

Assignment and Assumption of Lease by and between U.S. Stem Cell, Inc., American Cell Technology, LLC, and Sawgrass Business Plaza, LLC, dated October 24, 2019.

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934 the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Registrant

 

Date: October 24, 2019

 

U.S.  Stem Cell, Inc.

 

 By: /s/ Michael Tomas

 

 

Michael Tomas

 

 

Chief Executive Officer

 

 

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