UNITED STATES
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): November 21, 2016

 

Nuo Therapeutics, Inc.

(Exact name of Registrant as Specified in Charter)

 

Delaware 001-32518 23-3011702
(State or Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)

 

207A Perry Parkway, Suite 1, Gaithersburg, MD 20877

(Address of Principal Executive Offices) (Zip Code)

 

(240) 499-2680

(Registrant’s telephone number, including area code)

 

N/A

(Former Name or Former Address, if Changed Since Last Report)

 

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:

 

¨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))

 

  

 

 

Item 8.01. Other Events.

 

On November 21, 2016, Nuo Therapeutics, Inc. (the “Company”) reported that the initial PACE study results were presented during a clinical session at the American Heart Association meeting in November 2016.  There were no significant differences from baseline to six months between the cell and placebo groups for the four co-primary endpoints.  Additionally, there were no significant improvements for quality of life secondary endpoints, nor correlative relationships between changes in magnetic resonance outcomes and peak walking time. Post-hoc exploratory analysis revealed ALDH bright cells were associated with an increase in the number of collateral arteries in participants with completely occluded femoral arteries.  The Company understands that the Cardiovascular Cell Therapy Research Network is seeking to have the full study results published in a cardiovascular focused peer-reviewed journal in the next several months.

 

It is presently unclear whether the Bright Cell technology can be further developed clinically and, if so, whether the Company would strategically pursue any such development.   As previously disclosed, the Company’s primary focus is execution of the required Coverage with Evidence Development (CED) protocols and commercial development of the AurixTM technology for chronic wounds. 

 

Cautionary Statement Regarding Forward-Looking Statements

 

The statements contained in this Current Report on Form 8-K that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 31E of the Securities Exchange Act of 1934, including statements regarding the Company’s expectations, hopes, beliefs, intentions, or strategies regarding the future. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those projected in the forward-looking statements as a result of various factors. All forward-looking statements included in this document are based on information available to the Company on the date hereof and the Company assumes no obligation to update any such forward-looking statement. Prospective investors should also consult the risks described from time to time in the Company’s Reports on Forms 10-K, 10-Q and 8-K and Annual Reports to Shareholders.

 

The filing of this Form 8-K shall not be deemed an admission as to the materiality of any information herein.

 

  

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Nuo Therapeutics, Inc.  
       
       
  By:   /s/ David E. Jorden  
    David E. Jorden  
    Chief Executive Officer and
Chief Financial Officer
 

 

Date: November 21, 2016