Item 8.01 Other Events.

On April 20, 2021, Nuo Therapeutics, Inc. ("Nuo" or the "Company") announced that on April 13, 2021, the Center for Medicare & Medicaid Services ("CMS") published the final decision memo for the National Coverage Determination ("NCD") for Autologous Blood Derived Products for Chronic Non-Healing Wounds (CAG-00190R4). Nuo had initiated the NCD by making a formal request to open a reconsideration in May 2019. The company previously disclosed CMS' acceptance of the request in a Form 8-K filing on April 3, 2020 and the establishment of a National Coverage Analysis ("NCA") tracking sheet at CMS' website. The tracking sheet is available at https://www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?NCAId=300 and a separate link to the complete final decision memo is available via the CMS website.

Information appearing on the CMS website is not part of this Form 8-K.

Item 9.01 Financial Statements and Exhibits





(d) Exhibits



99.1   Press release dated April 20, 2021 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 coverage of autologous PRP beyond 20 weeks for DFUs and for the treatment
    of all chronic, non-healing wounds, which will be determined by local Medicare
    Administrative Contractors (MACs);
  ? 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 Company's nominal cash resources, the Company's need for immediate and
    substantial additional financing and its ability to obtain that financing,
    including in light of the low share price and significant volatility with
    respect to its common stock;
  ? the fact that the Company has no assets left to monetize other than the Aurix
    System itself; and
  ? the fact that the Company has not filed its annual reports on Form 10-K for
    the years ended December 31, 2019 and 2020 and has not filed any quarterly
    reports since its Form 10-Q for the quarter ended September 30, 2019, as well
    as other risks and uncertainties referenced in the Company's 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.

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