{"id":479248,"date":"2021-04-20T17:33:19","date_gmt":"2021-04-20T21:33:19","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/nuo-therapeutics-announces-publication-of-final-decision-memo-for-autologous-blood-derived-products-for-chronic-non-healing-wounds-by-centers-for-medicare-medicaid-services\/"},"modified":"2021-04-20T17:33:19","modified_gmt":"2021-04-20T21:33:19","slug":"nuo-therapeutics-announces-publication-of-final-decision-memo-for-autologous-blood-derived-products-for-chronic-non-healing-wounds-by-centers-for-medicare-medicaid-services","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/nuo-therapeutics-announces-publication-of-final-decision-memo-for-autologous-blood-derived-products-for-chronic-non-healing-wounds-by-centers-for-medicare-medicaid-services\/","title":{"rendered":"Nuo Therapeutics Announces Publication of Final Decision Memo for Autologous Blood Derived Products for Chronic Non-Healing Wounds by Centers for Medicare & Medicaid Services"},"content":{"rendered":"
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PR Newswire<\/p>\n<\/p><\/div>\n

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\n HOUSTON<\/span>, April 20, 2021<\/span> \/PRNewswire\/ —\u00a0Nuo Therapeutics, Inc. <\/b>(OTC Pink: AURX) (“Nuo” or the “Company”), today announced the recent publication of the final decision memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R4).\u00a0 On April 13, 2021<\/span>, Centers for Medicare & Medicaid Services (CMS) concluded in its final coverage decision memo (available at the URL at the bottom of this release) that Medicare will cover autologous platelet-rich plasma (PRP) for treatment of chronic non-healing diabetic wounds (DFUs) under section 1862(a)(1)(A) of the Social Security Act.\u00a0 This final decision follows the favorable proposed decision memo which was published December 21, 2020<\/span> and followed by a thirty-day public comment period.\u00a0 In its final decision memo, CMS concluded that the coverage for DFUs would be for a duration of 20 weeks and limited to devices whose FDA cleared indications include the management of exuding cutaneous wounds such as DFUs.\u00a0 Coverage of autologous PRP beyond 20 weeks for DFUs and for the treatment of all chronic, non-healing wounds will be determined by local Medicare Administrative Contractors (MACs).<\/p>\n

“The publication of the final decision memo with approved coverage for autologous PRP in DFUs is a welcomed addition to the treatment of DFUs”, commented David Jorden<\/span>, Nuo’s Chief Executive Officer.\u00a0 FDA clearance nearly fifteen years ago in fall 2007 was followed unfortunately by Medicare’s affirmation of national non-coverage in March 2008<\/span> in response to a Company reconsideration request (CAG-0019R2).\u00a0 Thus, Nuo began a focused and dedicated effort to collect clinical data in a field with known difficulties in establishing robust traditional clinical evidence which ultimately culminated in Nuo’s most recent reconsideration request in May 2019<\/span> on the basis of the DFU clinical outcomes data collected under Coverage with Evidence Development (CED). \u00a0The addition in the final decision memo of the requirement that a covered device producing autologous PRP have an FDA cleared indication specifically for the management of wounds is an important distinction that we are glad CMS accepted to ensure that the majority of PRP devices in the marketplace having orthopedic indications are not inappropriately covered for clinical indications poorly suited for the PRP concentrate outputs from these devices”. <\/p>\n

“As previously announced in October 2020<\/span>, Nuo successfully eliminated the post-bankruptcy Series A preferred stock held by Deerfield Management along with the senior secured notes which had provided important and accessible capital.\u00a0 I believe that, with a now clean capital structure, the Company has an opportunity to pursue a variety of alternatives after effectively mothballing the business over the past eighteen to twenty-four months.\u00a0 The paramount consideration will be ensuring that Aurix becomes available to patients with non-healing chronic wounds and in a manner that offers the company an opportunity to build value in the equity of the business.”<\/p>\n

\n https:\/\/www.cms.gov\/medicare-coverage-database\/details\/nca-decision-memo.aspx?NCAId=300&NCDId=217&ncdver=5&IsPopup=y&bc=AAAAAAAACAQA&<\/a>.<\/p>\n

The information included at this web address is not deemed to be incorporated by reference in this release and the address is provided as an inactive textual reference only.<\/p>\n

\n About Nuo Therapeutics<\/b>\n <\/p>\n

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.<\/p>\n

\n Forward-Looking Statements<\/b>\n <\/p>\n

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.<\/p>\n

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:<\/p>\n