Nuo Therapeutics, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Nuo Therapeutics, Inc. has filed its 2023 annual report (10-K) detailing its financial performance and business operations.</b>

AI Summary

Nuo Therapeutics, Inc. (AURX) filed a Annual Report (10-K) with the SEC on April 19, 2024. Nuo Therapeutics, Inc. filed its 2023 Form 10-K on April 19, 2024. The company's fiscal year ends on December 31st. Nuo Therapeutics, Inc. was formerly known as CYTOMEDIX INC and AUTOLOGOUS WOUND THERAPY INC. The company is incorporated in Delaware. Its business and mailing address is 8285 El Rio, Suite 150, Houston, TX 77054.

Why It Matters

For investors and stakeholders tracking Nuo Therapeutics, Inc., this filing contains several important signals. This filing provides a comprehensive overview of Nuo Therapeutics' financial health and strategic direction for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. Understanding the company's historical name changes and incorporation details offers context for its evolution and corporate structure.

Risk Assessment

Risk Level: low — Nuo Therapeutics, Inc. shows low risk based on this filing. The filing is a standard annual report (10-K) and does not contain immediate, significant financial or operational disclosures that would indicate a high-risk event.

Analyst Insight

Review the full 10-K filing for detailed financial statements, risk factors, and management discussion to form an investment thesis.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reported period end date)
• 2024-04-19 — Filing Date (Date the 10-K was filed)
• 001-32518 — SEC File Number (SEC filing identifier)
• 24858980 — Film Number (SEC film identifier)

Key Players & Entities

• Nuo Therapeutics, Inc. (company) — Filer name
• CYTOMEDIX INC (company) — Former company name
• AUTOLOGOUS WOUND THERAPY INC (company) — Former company name
• DE (jurisdiction) — State of incorporation
• HOUSTON (location) — Business address city
• TX (location) — Business address state
• 832-236-9060 (phone) — Business phone number
• 2024-04-19 (date) — Filing date

FAQ

Industry Context

Nuo Therapeutics, Inc. operates within the surgical and medical instruments and apparatus industry (SIC 3841).

Regulatory Implications

The filing is made under the Securities Exchange Act of 1934, which governs the reporting requirements for public companies.

What Investors Should Do

1. Analyze the financial statements within the 10-K for revenue, net income, and cash flow trends.
2. Review the 'Risk Factors' section for potential challenges and uncertainties facing the company.
3. Examine the 'Management's Discussion and Analysis of Financial Condition and Results of Operations' for insights into business performance and outlook.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 10-K.
• 2024-04-19: 10-K Filing Date — Date Nuo Therapeutics, Inc. submitted its annual report.

Year-Over-Year Comparison

This is the initial filing analyzed, so no comparison to a previous filing is available.

Key Financial Figures

• $0.0001 — (g) of the Exchange Act: Common Stock, $0.0001 par value (Title of class) Indicate
• $10.8 billion — , and is estimated to be an approximate $10.8 billion global market in 2021 with the North Am
• $4.15 billion — rican market estimated at approximately $4.15 billion in 2020. Estimates remain that 1-2% of
• $9 — diabetic foot ulcers cost an estimated $9-$13 billion annually in the U.S. alone.
• $13 billion — abetic foot ulcers cost an estimated $9-$13 billion annually in the U.S. alone. An aging po
• $1,749 — mbursement rate for the Aurix System is $1,749 per treatment, which we believe provide
• $800 — Aurix System at an approximate cost of $800 per treatment to wound care providers i
• $610,000 — 22, revenues increased to approximately $610,000 in 2023, and we expect revenues to exhi

Filing Documents

• aurx20231231_10k.htm (10-K) — 1045KB
• ex_650593.htm (EX-31) — 12KB
• ex_650594.htm (EX-32) — 5KB
• pic1.jpg (GRAPHIC) — 4KB
• 0001437749-24-012587.txt (&nbsp;) — 5018KB
• aurx-20231231.xsd (EX-101.SCH) — 46KB
• aurx-20231231_cal.xml (EX-101.CAL) — 37KB
• aurx-20231231_def.xml (EX-101.DEF) — 295KB
• aurx-20231231_lab.xml (EX-101.LAB) — 283KB
• aurx-20231231_pre.xml (EX-101.PRE) — 324KB
• aurx20231231_10k_htm.xml (XML) — 714KB

Business

ITEM 1. Business 1

Risk Factors

ITEM 1A. Risk Factors 7

Unresolved Staff Comments

ITEM 1B. Unresolved Staff Comments 15

Cybersecurity

ITEM 1C. Cybersecurity 15

Properties

ITEM 2. Properties 15

Legal Proceedings

ITEM 3. Legal Proceedings 15

Mine Safety Disclosures

ITEM 4. Mine Safety Disclosures 15 PART II 16

Market for Registrant ' s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

ITEM 5. Market for Registrant ' s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 16

[Reserved]

ITEM 6. [Reserved] 16

Management ' s Discussion and Analysis of Financial Condition and Results of Operations

ITEM 7. Management ' s Discussion and Analysis of Financial Condition and Results of Operations 17

Quantitative and Qualitative Disclosures about Market Risk

ITEM 7A. Quantitative and Qualitative Disclosures about Market Risk 20

Financial Statements and Supplementary Data

ITEM 8. Financial Statements and Supplementary Data 20

Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

ITEM 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 20

Controls and Procedures

ITEM 9A. Controls and Procedures 20

Other Information

ITEM 9B. Other Information 21

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

ITEM 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 21 PART III 22

Directors, Executive Officers and Corporate Governance

ITEM 10. Directors, Executive Officers and Corporate Governance 22

Executive Compensation

ITEM 11. Executive Compensation 24

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

ITEM 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 25

Certain Relationships and Related Transactions, and Director Independence

ITEM 13. Certain Relationships and Related Transactions, and Director Independence 27

Principal Accounting Fees and Services

ITEM 14. Principal Accounting Fees and Services 28 PART IV 29

Exhibits and Financial Statement Schedules

ITEM 15. Exhibits and Financial Statement Schedules 29

Form 10-K Summary

ITEM 16. Form 10-K Summary 29 Table of Contents Special Note Regarding Forward-Looking Statements Certain statements, other than purely historical information, in this Annual Report (including the section titled " Item 7. Management ' s Discussion and Analysis of Financial Condition and Results of Operations ") constitute "forward-looking statements". 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," "will," "will be," "will continue," "will likely result," "could," "may" and words of similar import. These statements reflect the Company's current view of future events and are subject to certain risks and uncertainties as noted in this Annual Report and in other reports filed by us with the Securities and Exchange Commission (the "SEC"), including Forms 8-K and 10-Q. These risks and uncertainties include, among others, the following: our limited revenue base and sources of working capital; our limited operating experience; our ability to continue as a going concern; the dilutive impact of raising additional equity or debt; our ability to timely and accurately report our financial results and prevent fraud if we are unable to maintain effective disclosure and internal controls; acceptance of our product by the medical community and patients; our ability to obtain adequate reimbursement from third-party payors; our ability to contract with healthcare providers; our reliance on several single source suppliers and our ability to source raw materials at affordable costs; our ability to protect our intellectual property; our compliance with g

Business

ITEM 1. Business Corporate Overview Nuo Therapeutics, Inc. is a Delaware corporation organized in 1998 under the name Informatix Holdings, Inc. In 1999, Autologous Wound Therapy, Inc., an Arkansas Corporation, merged with and into Informatix Holdings, Inc. and the name of the surviving corporation was changed to Autologous Wound Therapy, Inc. In 2000, Autologous Wound Therapy, Inc. changed its name to Cytomedix, Inc. ("Cytomedix"). In 2001, Cytomedix, filed for bankruptcy, from which it emerged in 2002 under a Plan of Reorganization. In September 2007, Cytomedix received 510(k) clearance for the Aurix System ("Aurix"), formerly known as the AutoloGel System, from the U. S. Food and Drug Administration ("FDA"). In April 2010, Cytomedix acquired the Angel Whole Blood Separation System from Sorin Group USA, Inc. In February 2012, Cytomedix, acquired Aldagen, Inc. ("Aldagen"), a privately held developmental cell-therapy company located in Durham, NC. In 2014, Cytomedix changed its name to Nuo Therapeutics, Inc. In 2016, Nuo filed for and emerged from bankruptcy under Chapter 11. Effective May 1, 2019, Nuo furloughed its remaining employees and ceased standard operational activities as it awaited developments concerning its reconsideration request with the Centers for Medicare & Medicaid Services ("CMS") regarding Medicare coverage for Aurix. Based on a favorable National Coverage Determination ("NCD") issued in April 2021, Nuo initiated restart activities for the business beginning in October 2021. Aldagen is a non-operational, wholly owned subsidiary of Nuo. Our principal offices are presently located in Houston, Texas. Our Business We are a regenerative therapies company focused on developing and marketing products for chronic wound care primarily within the U.S. We commercialize innovative 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) biolo

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View this 10-K filing on SEC EDGAR