Nuo Therapeutics, Inc. Announces Publication of Final Decision Memo for Autologous Blood Derived Products for Chronic Non-Healing Wounds by Centers for Medicare & Medicaid Services
April 20, 2021 at 05:30 pm EDT
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Nuo Therapeutics, Inc. (Nuo or the Company) announced the recent publication of the final decision memo for Autologous Blood-Derived Products for Chronic Non-Healing Wounds (CAG-00190R4). On April 13, 2021, 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. This final decision follows the favorable proposed decision memo which was published December 21, 2020 and followed by a thirty-day public comment period. 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. 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).
Nuo Therapeutics, Inc. is a regenerative therapies company. The Company is focused on developing and marketing products for chronic wound care primarily within the United States. The Company commercializes cell-based technologies that harness the regenerative capacity of the human body to trigger natural healing. Its flagship product, Aurix, is a biodynamic hematogel that uses a patientâs own platelets and plasma as a catalyst for healing. The Companyâs commercial offering consists of point of care technology for the safe and effective separation of autologous blood to produce a platelet-based therapy for the chronic wound care market. This offering is known as Aurix (the Aurix System), which produces a platelet rich plasma (PRP) gel at the point of care using the patientâs own platelets and plasma sourced from a small draw of peripheral blood. Aurix comprises a natural, endogenous complement of protein and non-protein signal molecules that contribute to effective healing.
Nuo Therapeutics, Inc. Announces Publication of Final Decision Memo for Autologous Blood Derived Products for Chronic Non-Healing Wounds by Centers for Medicare & Medicaid Services