Company Description
Nuo Therapeutics, Inc. (OTCQB: AURX) is a commercial-stage medical device and biomedical company in the field of chronic wound care. The company focuses on biodynamic therapies that harness a patient’s own biology to support healing. Its primary technology platform is the Aurix System, described as a biodynamic hematogel that uses a patient’s innate regenerative abilities for the management of a variety of wounds.
Core business and Aurix System
According to multiple company disclosures and press releases, the Aurix System is an autologous platelet-rich plasma (PRP) therapy indicated for the management of chronic wounds. It is FDA-cleared as an autologous PRP device, and has been described as the first FDA-cleared autologous PRP therapy specifically indicated for the management of chronic wounds and chronic diabetic wounds. The system is intended for use at the point of care and produces a biologically active gel from a patient’s own platelets and plasma.
Company materials state that the Aurix System is designed for stalled or difficult-to-manage wounds. These include full or partial thickness wounds, wounds with exposed bone and tendon, undermining with significant damage beneath the visible wound, sinus tracts, venous ulcers, and pressure injuries. Clinical studies referenced by Nuo Therapeutics, including work conducted with the Centers for Medicare & Medicaid Services (CMS) under Coverage with Evidence Development, have shown Aurix’s success in accelerating healing compared to other advanced wound modalities.
Clinical and reimbursement context
Nuo Therapeutics highlights the role of Medicare coverage in its business environment. In a CMS national coverage decision memo on autologous blood-derived products for chronic non-healing wounds, Medicare concluded that autologous PRP is covered for treatment of chronic non-healing diabetic wounds under specified conditions. The company notes that this decision followed years of clinical data collection and reconsideration requests related to diabetic foot ulcer outcomes.
The company has emphasized that Aurix is reimbursed by Medicare under a national coverage decision for blood-based products that have an FDA indication for use in the management of chronic wounds. Nuo Therapeutics has described this reimbursement framework as a key factor enabling the re-launch and broader commercial availability of Aurix for patients with chronic non-healing wounds.
Commercial stage operations and distribution
Nuo Therapeutics describes itself as a commercial stage medical device company that focuses on emerging opportunities in the evolving healthcare landscape for advanced wound care. The company has reported the establishment of a distribution network for Aurix, including multiple distribution agreements with entities experienced in blood-based biologics and wound care. It has highlighted Pacific Medical, Inc. as a significant distribution partner with numerous representatives trained on the Aurix product and engaged with physician and hospital facility customers.
In subsequent updates, Nuo Therapeutics has announced additional commercial relationships. These include the addition of the Aurix System to the wound care formulary of Wound Care Advantage, a wound care consulting firm that manages wound healing programs with partner hospitals, and a multi-year exclusive agreement under which Aurix serves as the sole PRP wound care therapy across the PAM Health network of long-term acute care hospitals, inpatient rehabilitation hospitals, and outpatient and wound care clinics.
Private label and strategic collaborations
The company has also entered into an exclusive private label distribution agreement with Smith+Nephew, a global medical technology company. Under this agreement, Smith+Nephew will market and sell the CENTRIO Platelet-Rich Plasma System, a branded version of the underlying Aurix System, to the United States wound care market. Nuo Therapeutics remains responsible for manufacturing the product. The Aurix product brand sold directly by Nuo continues to be available in the market under Nuo’s control, subject to customer overlap conditions described in the agreement.
In connection with this agreement, Nuo Therapeutics has disclosed that it received an upfront distribution fee, is entitled to certain minimum purchase commitments at agreed transfer pricing, and may receive reimbursement coverage milestone payments if specified coverage conditions are met. The company has referred investors to its Annual Report on Form 10-K for additional information about the distribution agreement.
Technology positioning and industry role
Nuo Therapeutics consistently characterizes its focus as biodynamic therapies that harness the body’s innate healing abilities. Within the advanced wound care market, Aurix is presented as an autologous, point-of-care PRP therapy that can be used across a variety of chronic wound types. The company has described Aurix as having a streamlined, one-minute spin process to generate a biologically active gel, and as an autologous wound treatment that is commercially available with Medicare reimbursement under a national coverage determination.
In company communications, Aurix is portrayed as a foundational product in an evolving chronic wound market where chronic non-healing wounds impose substantial clinical and economic burdens. Nuo Therapeutics has noted that chronic wounds affect a significant portion of the population and Medicare beneficiaries, and that advanced wound care spending has not always translated into broad improvements in healing outcomes. Within this context, the company positions Aurix as a therapy intended to support improved healing in patients with complex, non-healing wounds.
Corporate status and governance
Nuo Therapeutics, Inc. is incorporated in Delaware and, based on SEC filings, maintains its principal executive offices in Houston, Texas. The company files periodic reports, proxy statements, and current reports with the U.S. Securities and Exchange Commission. A definitive proxy statement for an annual meeting of stockholders and subsequent Form 8-K filings indicate that Nuo continues to hold annual meetings, elect directors, and engage an independent registered public accounting firm.
The company’s common stock trades on the OTCQB Venture Market tier under the symbol AURX. In earlier disclosures, Nuo Therapeutics described a period in which its shares were eligible only for unsolicited quotes on the Expert Market of the OTC Markets Group due to a lack of current public information. Subsequent communications reference the resumption of periodic financial reporting and approval for quotation and trading on the OTCQB tier.
Capital structure and historical developments
Nuo Therapeutics has reported several capital structure changes over time. In a recapitalization and exchange agreement, the company exchanged Series A preferred stock and converted senior secured notes into common stock, resulting in a capital structure consisting solely of common stock and no debt outstanding at that time. The company also disclosed the issuance and cancellation of warrants associated with these transactions.
In prior communications, Nuo Therapeutics discussed challenges related to limited cash resources, the need for additional financing, and uncertainty about a viable path forward for Aurix as an accessible product option for physicians treating Medicare beneficiaries with chronic wounds. The company stated that, in the absence of such a path, it might have to cease operations. Later updates, including the re-establishment of commercial operations, distribution agreements, and expanded access through partners such as PAM Health and Smith+Nephew, reflect the company’s efforts to position Aurix as a commercially available therapy under the Medicare coverage framework.
Exhibitions and industry engagement
Nuo Therapeutics has been selected to exhibit the Aurix System at the Vizient Innovative Technology Exchange, an event where suppliers demonstrate products and services to supply chain and clinical leaders from member hospitals. The company has described this as an opportunity to showcase how the Aurix technology may improve clinical outcomes and support advanced wound care delivery. Participation in such events aligns with Nuo’s stated goal of increasing awareness and adoption of autologous PRP therapies for chronic wounds.
Risk considerations
Company press releases and SEC filings include cautionary statements about risks and uncertainties. These have encompassed factors such as reimbursement decisions for autologous PRP beyond specified coverage periods, the company’s ability to secure and maintain adequate financing, reliance on the Aurix System as its primary asset, and the potential impact of changes in Medicare reimbursement mechanisms for advanced wound care products. Nuo Therapeutics directs investors to its SEC filings, including Annual Reports on Form 10-K and Current Reports on Form 8-K, for detailed discussions of these risks.
Summary
Overall, Nuo Therapeutics, Inc. is focused on the development and commercialization of the Aurix System, an autologous PRP-based hematogel used in chronic wound management. Through distribution partnerships, formulary inclusion, and collaborations with healthcare networks, the company seeks to expand access to its biodynamic wound care therapy within a reimbursement environment shaped by Medicare coverage decisions for autologous blood-derived products.