Nuo Therapeutics, Inc. (Form: 8-K, Received: 03/22/2019 08:47:15)

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 earlie st event reported): March 19 , 2019

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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

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. ☐

Item 1.01 Entry into a Material Definitive Agreement

On March 19, 2019, Nuo Therapeutics, Inc. (the “Company”) entered into amendments to the convertible promissory notes issued to Auctus Fund, LLC (“Auctus”) and EMA Financial, LLC (“EMA” and, collectively with Auctus, the “Investors”) on September 17, 2018. The amendments extend the date when the Company may prepay the notes and deferred the date upon which the Investors can initiate conversion of the notes into common shares of the Company pursuant to the notes’ terms until April 30, 2019. The Company paid the Investors an amendment fee totaling $35,000 representing ten percent (10%) of the face value of the notes.

The above descriptions of the convertible note amendments does not purport to be complete and is qualified in its entirety by the full text of each amendment, attached as Exhibits 10.1 and 10.2, respectively, which are incorporated herein by reference.

Item 7.01 Regulation FD Disclosure

The Company today issued a press release disclosing its continued interactions with the Center for Medicare & Medicaid Services (“CMS”) with regards to efforts to obtain a commitment from CMS to reopen the National Coverage Decision for autologous blood-derived products for chronic non-healing wounds. Additional details can be found in the press release attached hereto as Exhibit 99.1, which details are incorporated by reference herein.

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 7.01 and Exhibit 99.1 hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shal l not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

10.1	Convertible Promissory Note Amendment with Auctus Funds LLC dated March 19, 2019

10.2	Convertible Promissory Note Amendment with EMA Financial, LLC dated March 19, 2019

99.1	Press release, dated March 22, 2019, issued by the Company.

Forward-Looking Statements

This Form 8-K contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance, or achievements, and may contain the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “the facts suggest,” “will be,” “will continue,” “will likely result” or, in each case, their negative, or words or expressions of similar meaning.

These statements reflect the Company’s current view of future events and are subject to certain risks and uncertainties, which include, among others, the following:

●	the Company’s ability to receive any commitment from CAG to reopen the NCD for Aurix in time to prevent the Company from ceasing its operations;
●	significant uncertainty surrounding an agreed path forward for Aurix as an accessible product option for physicians treating Medicare beneficiaries with chronic wounds – in the absence of such a path, the Company will likely have to cease operations;
●	the possibility that a more comprehensive and definitive analysis of the wound healing data submitted to CAG could come to materially different conclusions than the results of the Company’s limited and preliminary analysis;
●	the continuing rapid depletion of the Company’s cash resources, the Company’s need for immediate and substantial additional financing (without which it faces liquidation) and its ability to obtain that financing, including in light of its outstanding convertible notes, Series A preferred stock and the low share price and significant volatility with respect to its common stock - if the Company were required to liquidate today, the holders of its common stock would not receive any consideration for their common stock;
●	the fact that the Company has no significant assets left to monetize other than the Aurix System itself; as well as other risks and uncertainties referenced in the Company’s other SEC filings.

Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements, and the Company’s business, results of operations, financial condition and cash flows may be materially and adversely affected. Given these risks and uncertainties, investors should not place undue reliance on forward-looking statements as a prediction of actual results. Except to the extent required by applicable law or rules, the Company undertakes no obligation and does not intend to update, revise or otherwise publicly release any revisions to its forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of any unanticipated events.

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: March 22, 2019

Exhibit 10.1

AMENDMENT TO THE CONVERTIBLE PROMISSORY NOTE ISSUED ON SEPTEMBER 17, 2018

THIS AMENDMENT TO THE CONVERTIBLE PROMISSORY NOTE ISSUED ON September 17, 2018, (the “Amendment”) is made effective as of March 19, 2019 (the “Effective Date”), by and between NUO THERAPUETICS, INC., a Delaware corporation (the “Company”), and Auctus Fund, LLC, a Delaware limited liability company (the “Holder”) (each the Company and the Holder a “Party” and collectively the “Parties”).

BACKGROUND

A. The Company and Holder are the parties to that certain securities purchase agreement (the “SPA”) dated September 17, 2018, pursuant to which the Company issued to Holder a convertible promissory note on even date in the original principal amount of $175,000.00 (the “Note”); and

B. The Parties desire to amend the Note as set forth expressly below.

NOW THEREFORE, in consideration of the execution and delivery of the Amendment and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1. As of the Effective Date of this Amendment, if : (i) no Event of Default (as defined in the Note) (each an “Event of Default”) shall have occurred; (ii) there is no breach of this Amendment; (iii) the Company wires the amount of $17,500 to the Holder in accordance with the wire transfer instructions attached hereto as Exhibit A no later than March 20, 2019 (“Payment Deadline”) (which will not reduce the balance owed under the Note); then: (a) the references to “one hundred eighty (180) days” in Sections 1.9(b) and 1.9(c) of the Note shall be replaced with “two hundred twenty-four (224) days” and (b) the Holder shall refrain from exercising its right to convert the Note until April 30, 2019. In the event that all other noteholders of convertible debt of the Company as of the Effective Date (i) do not also agree in a signed writing to extend the period that Company is permitted to prepay the Company’s other convertible debt by at least 44 days and/or (ii) fail to agree in a signed writing to refrain from exercising their conversion rights under their respective convertible debt by at least 44 days, then this Amendment may be declared null and void at the option of the Holder.

2. Upon the: (i) occurrence of an Event of Default under the Note or (ii) Company’s breach of any provision or representation in this Amendment, then this Amendment may be declared null and void at the option of the Holder.

3. This Amendment shall be deemed part of, but shall take precedence over and supersede, any provisions to the contrary contained in the Note. Except as specifically modified hereby, all of the provisions of the Note, which are not in conflict with the terms of this Amendment, shall remain in full force and effect.

4. This Amendment may be executed in any number of counterparts, each of which when so executed and delivered shall be deemed to be an original and all of which together shall be deemed to be one and the same agreement. Any signature transmitted by facsimile, e-mail, or other electronic means shall be deemed to be an original signature.

[Signature page to follow]

IN WITNESS WHEREOF, the parties hereto have executed this Amendment as of the date first above written.

Nuo Therapeutics

By: /s/ David Jorden

Name: David E. Jorden

Title: CEO

Auctus Fund, LLC

By: /s/ Lou Posner

Name: Lou Posner

Title: Managing Director

Exhibit 10.2

AMENDMENT TO THE CONVERTIBLE PROMISSORY NOTE ISSUED ON SEPTEMBER 17, 2018

THIS AMENDMENT TO THE CONVERTIBLE PROMISSORY NOTE ISSUED ON September 17, 2018, (the “Amendment”) is made effective as of March 19, 2019 (the “Effective Date”), by and between NUO THERAPUETICS, INC., a Delaware corporation (the “Company”), and EMA Financial, LLC, a Delaware limited liability company (the “Holder”) (each the Company and the Holder a “Party” and collectively the “Parties”).

BACKGROUND

A. WHEREAS, The Company and Holder are the parties to that certain securities purchase agreement (the “SPA”) dated September 17, 2018 pursuant to which the Company issued to Holder a convertible note on even date, in the original principal amount of $175,000.00 (the “Note”); and

B. WHEREAS, in accordance with the terms of Section 1.8 of the Note the Company may prepay the Note until March 17, 2019 (the “Prepayment Termination Date”), with no prepayment permitted thereafter; and

C. WHEREAS, the Parties desire to amend the Note as set forth expressly below.

1. As of the Effective Date of this Amendment if : (i) no Event of Default (as defined under the Note) shall have occurred; (ii) there is no breach of any of the terms of this Amendment; (iii) the Company wires the amount of $17,500 to the Holder in accordance with the wire transfer instructions attached hereto as Exhibit A no later than end of business day March 20, 2019 (“Payment Deadline”); then: (a) the Prepayment Termination Date shall be April 30, 2019, provided that any prepayment of the Note prior to or on this new Prepayment Termination Date shall be subject to the last applicable Prepayment Factor (which is 145% of the outstanding balance of the Note) as set forth in the Note; and (b) the Holder shall refrain from exercising its right to convert the Note until April 30, 2019, provided however, in the event that the Company and all other holders of convertible debt do not as of the date hereof also agree in a signed writing in the same form and substance as the terms contained in this Amendment, specifically, agreeing to extend the period that Company is permitted to prepay its other convertible notes by at least 44 days, and/or the other noteholders fail to agree in a signed writing to refrain from exercising their conversion rights under their respective outstanding convertible notes by at least 44 days then this Amendment shall be null and void.

2. Upon the: (i) occurrence of an Event of Default (as defined in the Note), or (ii) Company’s breach of any provision or representation in this Amendment this Amendment shall be null and void and the Holder shall automatically, immediately and without further action be entitled to all its rights, privileges, and preferences under the Note.

3. This Amendment shall be deemed part of but shall take precedence over and supersede any provisions to the contrary contained in the Note. Except as specifically modified hereby, all of the provisions of the Note, which are not in conflict with the terms of this Amendment, shall remain in full force and effect.

[Signature page to follow]

IN WITNESS WHEREOF, the parties hereto have executed this Amendment as of the date first above written.

Nuo Therapeutics

By: /s/ David Jorden

Name: David E. Jorden

Title: CEO

EMA Financial, LLC

By: /s/ Jamie Beitler

Name: Jamie Beitler

Title: Authorized Signatory

Exhibit 99.1

Nuo Therapeutics Provides Update on Ongoing Interactions with Centers for Medicare & Medicaid Services

Gaithersburg, MD – March 22 , 2019 – Nuo Therapeutics, Inc. (OTCQB: AURX) (“Nuo” or the “Company”), today provided an update on ongoing interactions with Centers for Medicare & Medicaid Services’ (CMS) Coverage and Analysis Group (CAG) representatives. As previously disclosed by the Company, the discussions to date have centered around the feasibility of re-opening the National Coverage Determination (NCD) for autologous blood-derived products for chronic non-healing wounds. On its investor conference call held on January 22, 2019, the Company indicated that it would be submitting to CAG a draft manuscript describing the Coverage with Evidence Development (CED) study design, methods, and statistical data analysis for diabetic foot ulcer subjects enrolled in the CED study protocol including an expectation that CMS would provide feedback to the Company in a timely manner. The Company has had further interactions with CMS in the intervening period and has been working to answer certain questions and clarifications requested by CAG. The Company has resubmitted a draft manuscript to CAG reflecting additional statistical data analysis which continues to indicate a statistically significant healing benefit for Aurix in the proportion of patients healed during the specified protocol treatment period. The Company can provide no assurance on the ultimate outcome of its further interactions with CMS with regards to its NCD reconsideration request.

In addition, the Company executed amendments effective March 19, 2019 with each of the two convertible note holders under the original securities purchase agreements executed on September 17, 2018. Under the amendments, the note holders have agreed to a forbearance period whereby they will not seek any conversion of the notes until at least April 30, 2019. The Company paid an amendment fee totaling $35,000 representing ten percent (10%) of the face value of the notes.

As the Company disclosed previously, in the absence of a viable path forward for Aurix as an accessible product option for physicians treating Medicare beneficiaries with chronic wounds, the Company will likely proceed to cease operations and its CED effort would be officially terminated.

About Nuo Therapeutics

Nuo Therapeutics, Inc. is a biomedical company offering biodynamic therapies for chronic wound care. The Company's Aurix System is a biodynamic hematogel that harnesses a patient's innate regenerative abilities for the management of a variety of wounds. For additional information, please visit www.nuot.com or www.aurixsystem.com .

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance, or achievements, and may contain the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “the facts suggest,” “will be,” “will continue,” “will likely result” or, in each case, their negative, or words or expressions of similar meaning.

These statements reflect the Company’s current view of future events and are subject to certain risks and uncertainties, which include, among others, the following:

	●	the Company’s ability to receive any commitment from CAG to reopen the NCD for Aurix in time to prevent the Company from ceasing its operations;
	●	significant uncertainty surrounding an agreed path forward for Aurix as an accessible product option for physicians treating Medicare beneficiaries with chronic wounds – in the absence of such a path, the Company will likely have to cease operations;
	●	the possibility that a more comprehensive and definitive analysis of the wound healing data to be included in the draft publication expected to be submitted to CAG could come to materially different conclusions than the results of the Company’s limited and preliminary analysis;
	●	the continuing rapid depletion of the Company’s cash resources, the Company’s need for immediate and substantial additional financing (without which it faces liquidation) and its ability to obtain that financing, including in light of its outstanding convertible notes, Series A preferred stock and the low share price and significant volatility with respect to its common stock - if the Company were required to liquidate today, the holders of its common stock would not receive any consideration for their common stock;
	●	the fact that the Company has no significant assets left to monetize other than the Aurix System itself; as well as other risks and uncertainties referenced in the Company’s SEC filings.

Contact:

Nuo Therapeutics :

David Jorden

CEO/CFO

(240) 499-2680

djorden@nuot.com