Nuo Therapeutics, Inc. develops regenerative therapies and wound care products, primarily selling the Aurix System which processes blood into platelet-rich plasma for wound treatment.

# Company Summary: Nuo Therapeutics, Inc.

## Core Business
- **Industry:** Regenerative therapies and wound care
- **Main Product:** Aurix System
  - FDA-cleared in 2007 under Section 510(k) as a device for processing peripheral blood into autologous platelet-rich plasma (PRP).
  - Produces a gel using the patient's own blood, which is applied to treat chronic wounds such as diabetic foot ulcers, leg ulcers, pressure ulcers, and surgically debrided wounds.
  - The product leverages the regenerative capacity of platelets, releasing growth factors and signaling molecules (e.g., VEGF, PDGF, EGF, FGF, TGF-β) that promote healing and tissue regeneration.
  - Known for its antimicrobial properties, releasing peptides effective against pathogens like MRSA.

## Market Position & Strategy
- Focused on developing and marketing products within the U.S. for chronic wound care.
- Market estimated at approximately $10.8 billion globally (2021), with North American market at about $4.15 billion (2020).
- The company aims to demonstrate clinical benefits, increase physician awareness, establish relationships through distributor and sales agent arrangements, and grow revenues through these relationships.
- Revenues have been increasing:
  - 2023: ~$609,000
  - 2024: ~$1,365,000

## Customers & Revenue
- Revenue primarily from sales of Aurix to hospital outpatient wound care clinics and private practice physicians.
- As of December 31, 2024:
  - Over **200** contractual relationships with third-party representatives.
- Approximate revenue:
  - 2023: ~$609,000
  - 2024: ~$1,365,000

## Employees & Human Resources
- Total employees as of December 31, 2024: **9** full-time, salaried employees
- No employees are covered by collective bargaining agreements or represented by unions.

## Financial Overview
- **2024 Results:**
  - Revenue: ~$1,365,000
  - Gross profit: ~$1,062,000
  - Operating expenses: ~$3,520,000
  - Net loss: approximately **$2.3 million**
- **2023 Results:**
  - Revenue: ~$609,000
  - Gross profit: ~$482,000
  - Operating expenses: ~$3.65 million
  - Net loss: approximately **$3.2 million**
- **Cash & Assets (as of December 31, 2024):**
  - Cash: ~$0.3 million
  - Total current assets: ~$0.8 million
  - Total assets: ~$1.2 million
- **Liabilities:**
  - Current liabilities: ~$0.6 million
  - Total liabilities: ~$0.68 million
- **Stockholders’ Equity:** ~$0.5 million
- **Notes:** The company operates at a net loss and has an accumulated deficit of approximately **$32.3 million** as of December 31, 2024.

## Additional Notes
- The company has entered into a Distribution Agreement with Smith+Nephew (March 31, 2025) to supply a private label of the Aurix product for exclusive U.S. distribution.
- Prior to restarting operations in 2022, the company had ceased standard activities since May 1, 2019, and awaited CMS Medicare coverage approval.
- The company remains small with limited revenue, and it is actively working on expanding its customer base and distribution channels.

Nuo Therapeutics, Inc. is a regenerative therapies company focused on developing and marketing products for chronic wound care, primarily featuring the Aurix System for producing platelet-rich plasma.

# Nuo Therapeutics, Inc. Overview

**Corporate Background**
- **Founded:** 1998 (originally as Informatix Holdings, Inc.)
- **Headquarters:** Houston, Texas
- **Former Names:** 
  - Informatix Holdings, Inc.
  - Autologous Wound Therapy, Inc.
  - Cytomedix, Inc.

**Business Focus**
Nuo Therapeutics, Inc. is a regenerative therapies company that develops and markets products primarily for chronic wound care in the U.S. The company's primary offering is the **Aurix System**, a point-of-care technology designed to separate autologous blood to produce a platelet-rich plasma (PRP) gel for use in treating non-healing wounds.

### Current Product Offering: Aurix System
- **FDA Clearance:** Received in September 2007 under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (FDCA). 
- **Indications:** Approved for managing various exuding wounds, including diabetic ulcers, leg ulcers, and pressure ulcers.
- **Mechanism:** 
  - Produces a PRP gel using the patient’s own platelets and plasma. 
  - Activated platelets release growth factors and proteins that facilitate natural healing.

### Market Insights
- **Chronic Wound Market Size:** Approximately $10.8 billion globally (2021), with the North American market around $4.15 billion (2020).
- **Prevalence:** 1-2% of the developed population will experience a chronic wound at least once in their lifetime, leading to substantial healthcare costs (e.g., $9-$13 billion annually for diabetic foot ulcer treatment in the U.S.).

### Business Metrics
- **Employees:** As of December 31, 2023, Nuo Therapeutics had **9 full-time employees**.
- **Customer Base:** The company has established relationships with **more than 200 individual distributor representatives**, primarily in hospital outpatient wound care clinics and private practice settings.
- **Revenue:**
  - Limited initial commercial sales in **2022**.
  - **2023 Revenue:** Approximately **$610,000** from Aurix product sales, with expectations for continued growth.
- **Net Loss:** Approximately **$3.2 million** for both 2023 and 2022.

### Strategic Focus
- Increase physician awareness of Aurix’s benefits.
- Expand distributor arrangements to support commercial growth.
- Ensure proper reimbursement processes through Medicare after favorable National Coverage Determination (NCD) established in April 2021.

### Regulatory and Compliance Landscape
- The Aurix System is subject to extensive regulation by the FDA and similar international authorities, requiring compliance with safety and efficacy standards.
- The company also faces risks related to fraud and abuse laws, including the Anti-Kickback Law and the Stark Law.

In summary, Nuo Therapeutics is positioned to harness autologous regenerative therapies in chronic wound care, leveraging an innovative product (Aurix) and an expanding distributor network against a backdrop of significant market potential and rigorous regulatory oversight.

Nuo Therapeutics, Inc.

10-K / April 1, 2025

10-K / April 19, 2024

10-K / April 1, 2025

Company Summary: Nuo Therapeutics, Inc.

Core Business

Market Position & Strategy

Customers & Revenue

Employees & Human Resources

Financial Overview

Additional Notes