Nuo Therapeutics Stock

Nuo Therapeutics, Inc., a regenerative therapies company, focuses on developing and marketing products for chronic wound care primarily within the United States (U.S.).

The company commercializes cell-based technologies that harness the regenerative capacity of the human body to trigger natural healing. The use of autologous (i.e., from self, the patient's own) biological therapies for tissue repair and regeneration is part of a clinical strategy designed to improve long-term recovery in inherently complex chronic conditions with significant unmet medical needs.

The company's commercial offering consists of a 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' or the 'Aurix System'. The U. S. Food and Drug Administration (FDA) cleared the Aurix System for marketing in 2007 as a device under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FDCA). Aurix is one of two platelet derived products cleared by the FDA for chronic wound care use and is indicated for most exuding wounds. The advanced wound care market, within which Aurix competes, is composed of advanced wound care dressings, wound care devices, and wound care biologics.

The Aurix System produces a platelet rich plasma (PRP) gel at the point of care using the patient's 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. During treatment, the patient's platelets are activated and release hundreds of growth factor proteins and other signaling molecules that form a biologically active hematogel. Aurix delivers concentrations of the natural complement of cytokines, growth factors and chemokines that are known to regulate angiogenesis (i.e., the development of new blood vessels), cell growth, and the formation of new tissue. Once applied to the prepared wound bed, the biologically active Aurix hematogel can restore the balance in the wound environment to transform a non-healing wound to a wound that heals naturally.

In 2012, a Medicare National Coverage Determination (NCD) from Centers for Medicare & Medicaid Services (CMS) reversed a twenty-year old non-coverage decision for autologous blood derived products used in wound care. This NCD allowed for Medicare coverage under the Coverage with Evidence Development (CED) program. CED programs have been employed for a selected number variety of other therapies, including transcatheter aortic valve repair and cochlear implantation. Under the CED program, CMS provides reimbursement for items or services on the condition that they be furnished in approved clinical protocols or in the collection of additional clinical data. Under the CED program, a facility treating a patient with Aurix was reimbursed by Medicare when health outcomes data were collected to inform future coverage decisions. The intent of the CED program was to evaluate the outcomes of Aurix therapy for the broader Medicare population when it is used in a real world continuum of care.

On May 17, 2019, the company transmitted a letter memorandum to CMS' Coverage and Analysis Group (CAG) in support of the company's complete formal request for reconsideration of the then existing national coverage determination based on clinical data collected and published under the CED program. The complete formal public request for reconsideration was made on May 8, 2019 in accordance with the applicable requirements.

On April 13, 2021, CMS issued a final coverage decision memo indicating that Medicare would nationally cover autologous PRP for the treatment of chronic non-healing diabetic wounds for a duration of 20 weeks under Section 1862(a)(1)(A) of the Social Security Act. This coverage applies when using devices whose FDA-cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers. Coverage of autologous PRP beyond 20 weeks for diabetic foot ulcers and for the treatment of all other chronic, non-diabetic, non-healing wounds will be determined by local Medicare Administrative Contractors.

Although FDA cleared the Aurix System for marketing in 2007 under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, CMS only established economically viable reimbursement for the product beginning in 2016.

Strategy

The company's commercial focus is establishing engagement with providers treating chronic non-healing wounds to demonstrate the clinical benefits result from the use of Aurix in the treatment of complex wounds. Increasing physician awareness of the differentiating attributes of Aurix will be key to establishing a base of product revenues upon which to grow. As of December 31, 2022, the company had established contractual relationships with more than 100 individual distributor representatives, including a multi-state agreement with Pacific Medical, Inc. covering multiple large markets in the western United States. The number of distributor representatives may continue to expand modestly in the months ahead but the current focus is establishing commercial customer relationships with wound care providers in primarily hospital outpatient wound care clinics and ensuring that the reimbursement mechanisms are appropriately administered by the local Medicare Administrative Contractors in the support of the April 2021 national coverage determination.

Customers

The company's revenues are derived from the sale of the Aurix product to customers comprising primarily hospital outpatient wound care clinics and other private practice physicians treating chronic wounds.

Suppliers

A reagent, bovine thrombin (Thrombin JMI), used for the company's Aurix product is available exclusively through Pfizer.

Government Regulation

Each component of the Aurix System is a legally marketed product that has been cleared by FDA.

As a specification developer, manufacturer, and distributor of medical devices, the company complies with other regulations and standards, such as the FDCA and implementing regulations set forth in 21 CFR et seq. and also ISO 13485. Additionally, the company is subject to periodic inspections by the governing bodies to assess compliance with current good manufacturing practices (cGMP) regulations. Accordingly, manufacturers, such as the company must continue to expend time, money, and effort around production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.

History

The company, a Delaware corporation, was founded in 1998. It was incorporated in 1998. The company was formerly known as Autologous Wound Therapy, Inc. and changed its name to Cytomedix, Inc. in 2000 and then to Nuo Therapeutics, Inc. in 2014.