Nuo Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Mar 30, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 30, 2026
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What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-K
Period ended 2024-12-31; filed 2025-04-01.
0001437749-25-010379
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-K
Period ended 2025-12-31; filed 2026-03-30.
0001437749-26-010360
ITEM 7. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 51 previous paragraphs and 65 current paragraphs.
33 unchanged; 13 reworded; 19 added; 3 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (19)
Current report
Our only significant current commercial offering consists of point of care technology for the 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”. Although FDA cleared the Aurix System for marketing for wound care management in 2007 under Section 510(k) of the FDCA, CMS only established economically viable reimbursement for Aurix upon the issuance of a NCD for autologous blood-based products in April 2021. For 2026, the CMS national average reimbursement rate for the Aurix System is $2,108 in POS 22 and $1,064 in POS 11.
Current report
Our current commercial focus is to continue engaging and establishing relationships with providers treating chronic non-healing wounds to demonstrate the clinical benefits we believe 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. We anticipate developing these relationships with clinical providers and treatment facilities primarily by establishing a variety of distributor and sales agent arrangements primarily throughout the United States.
Current report
The $1,500,000 upfront distribution fee will be recognized ratably as revenue on a straight-line basis over the initial five-year term of the Distribution Agreement. For the year ended December 31, 2025, we recognized $225,000 of license revenue under the Distribution Agreement.
Current report
On May 14, 2025, we entered into Amendment No. 1 (the “First Amendment”) to the Distribution Agreement. The First Amendment supplemented the Distribution Agreement by additionally providing for an interim sales agency arrangement whereby Smith+Nephew was entitled to act as sales agent on an interim basis for the sale of products under the Aurix brand to certain Smith+Nephew customers. As compensation, Smith+Nephew was entitled to a commission on net sales of the Nuo branded products sold to the Smith+Nephew customers. In accordance with its terms, the First Amendment's interim sales agency arrangement terminated on December 31, 2025. On December 30, 2025 and effective January 1, 2026, we entered into Amendment No. 2 to the Distribution Agreement to add certain expansion kits in connection with the Private Label product.
Current report
Loan and Security Agreement
Current report
On January 21, 2026, we entered into a Loan and Security Agreement (the “Loan Agreement”) with four lenders (collectively, the “Lenders”), including a director of Nuo. The Loan Agreement provides for loans in an aggregate principal amount of up to $1.6 million with (a) $1.0 million funded on the initial closing date (the “Initial Funding”) and (b) $600 thousand to be funded, if requested in advance by us and subject to closing conditions, on September 30, 2026 (the “Second Funding”). The closing of the Initial Funding occurred on January 23, 2026.
Current report
At the closing of the Initial Funding, we issued a Secured Promissory Note (each, an “Initial Note”) to each of the Lenders and upon any Second Funding, we will issue an additional Secured Promissory Note (each, if any, a “Second Note”). The Initial Note bears interest at an annual rate of 10%. If Nuo requests a Second Funding, the Second Note will bear interest at an annual rate of 12% and the interest rate of the Initial Note will also increase to an annual rate of 12% upon the Second Funding.
Current report
The maturity date of the Initial Note and any Second Note is December 31, 2028 (the “Maturity Date”).
Current report
Interest on the Initial Note and, if any, the Second Note (together, the “Notes”) will be payable in warrants and not in cash. Interest on the Notes will be payable and issued at the Maturity Date or earlier upon certain prepayments. Interest on the Notes will accrue on a quarterly calendar basis without regard to partial quarters. The Notes are interest only through December 31, 2026. The principal on the Notes is repayable in cash in equal quarterly installments on the last business day of each calendar quarter commencing March 31, 2027 and continuing to the Maturity Date.
Current report
We may, at our option on the last business day of a calendar quarter commencing December 31, 2026, voluntarily prepay the Notes in their entirety by paying the then outstanding principal balance and all accrued interest on the Notes, subject to a prepayment fee equal to 1.5% of the then outstanding principal balance if the Notes are prepaid on or after December 31, 2026 but before December 31, 2027, with no prepayment fee applicable to such prepayments on or after December 31, 2027. The prepayment fee, if any, is payable in Prepayment Warrants as described below, and not in cash, that will vest in the event of a voluntary prepayment.
Current report
In addition, the Loan Agreement mandates the prepayment of the Notes in the event of (A) an equity financing of at least $5 million, (B) certain changes in control as defined in the Loan Agreement, or (C) a default by Nuo. In the event of such an equity financing or change in control, we have agreed to repay the Notes in their entirety by paying the then outstanding principal balance and all accrued interest on the Notes, subject to a prepayment fee equal to 2.75% of the then outstanding principal balance if such event occurs before December 31, 2026 and 1.5% of the then outstanding principal balance if such event occurs on or after December 31, 2026 but before December 31, 2027, with no prepayment fee applicable if such event occurs on or after December 31, 2027. In the event of a default, we have agreed to repay the Notes in their entirety by paying the then outstanding principal balance and all accrued interest on the Notes, subject to a prepayment fee equal to 2.75% of the then outstanding principal balance. The prepayment fee, if any, is payable in warrants, and not in cash, that will vest in the event of a mandatory prepayment.
Current report
The Notes are secured by a lien upon and security interest in all of the Company’s assets, including intellectual property. The Loan Agreement contains customary representations, warranties, and covenants.
Current report
Total revenues for the year ended December 31, 2025 totaled approximately $3.3 million including $225,000 of distribution fee revenue related to the Smith+Nephew distribution agreement. Product revenues for the year ended December 31, 2025 totaled approximately $3.1 million in comparison to product and total revenues of approximately $1.4 million for the year ended December 31, 2024 representing an increase of approximately $1.7 million or approximately 126%. Product revenues associated with the Smith+Nephew private label distribution arrangement were recognized for the first time in the second half of 2025 consisting of (i) centrifuge devices sold to Smith+Nephew in anticipation of its Private Label product launch and (ii) initial fulfillment of purchase orders for stocking of Private Label kits. Associated gross profit was approximately $2.2 million for the year ended December 31, 2025 in comparison to approximately $1.1 million of gross profit in the year ended December 31, 2024.
Current report
The increase in revenues was due primarily to (i) increased Aurix product revenues resulting from an expanding customer base over the past year, (ii) the initial Smith+Nephew product revenues for centrifuge devices and kits solely in the second half of 2025 discussed above and (iii) distribution fee revenue recognized under the distribution agreement. Aggregate gross margin was approximately 67% for the year ended December 31, 2025 as compared to approximately 78% in the prior 2024 year. The gross margin decline was primarily due to centrifuge devices sold to Smith+Nephew at a near zero gross margin on the negotiated transfer price of the devices including the impact of tariff surcharges from the device manufacturer which was partially offset by distribution fee revenue having no associated cost.
Current report
Total operating expenses increased approximately $1,214,000 to approximately $4,735,000 comparing the year ended December 31, 2025 to the prior full year 2024 period. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $399,000 due largely to the combination of increased legal fees associated with the negotiation and finalization of the Smith+Nephew distribution agreement and SEC registration statements filed during the year and consulting expenses for our quality management system and reimbursement support services, (ii) third party commission expense of approximately $314,000 for independent sales representatives and distributors resulting from increased Aurix product revenues, and (iii) compensation and benefit costs of approximately $272,000 attributable primarily to increased salary costs and added sales management personnel.
Current report
On May 12, 2025, the SEC declared our shelf registration statement on Form S-3 effective. The shelf registration statement enables us to offer and sell, from time to time in one or more offerings, shares of our common stock with an aggregate offering amount not exceeding $15 million, subject to the provisions of Form S-3. The shelf registration statement could provide us with access to liquidity from the public markets if we are able and should we decide to utilize it for that purpose.
Current report
During the year ended December 31, 2025, we sold 527,612 shares of common stock to certain accredited investors pursuant to a Securities Purchase Agreement in a private placement which closed in July 2025 for total proceeds of $791,418. We issued 283,853 shares of common stock upon option exercises for gross proceeds of $113,541. As of December 31, 2025, $500,000 in secured notes were prefunded by two lenders which included $200,000 advanced from a related party.
Current report
Cash used in investing activities for year ended December 31, 2025 of approximately $275,000 primarily represents approximately $220,000 in expenditures for the purchase of Aurix centrifuge devices.
Current report
Cash provided by financing activities for the year ended December 31, 2025 reflects proceeds of (i) $791,418 from the sale of 527,612 shares of common stock in a private placement which closed in July 2025, (ii) $113,541 from the exercise of common stock options, and (iii) $500,000 from the prefunding of two secured notes on December 31, 2025.
Removed paragraphs (3)
Previous report
Our only current 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 (the "Aurix System"). The Company ceased normal operating activities effective May 1, 2019, as it awaited developments concerning Medicare coverage of the Aurix System under its National Coverage Decision (“NCD”) reconsideration request. Product sales were reinitiated in mid-2022 after the favorable NCD determination was issued in April 2021, the Aurix System supply chain was re-established, and equity capital was accessed in December 2021 via the early exercise of warrants under a warrant modification agreement.
Previous report
Product revenues for the year ended December 31, 2024 totaled approximately $1,365,000 with approximately $1,062,000 of associated gross profit and a resulting gross margin of approximately 78%. Product revenues for the year ended December 31, 2023 totaled approximately $609,000 and associated gross profit for the year was approximately $482,000 with a resulting gross margin of 79%. The approximately 124% increase in product revenues for 2024 versus 2023 is attributable to increased adoption of the Aurix product by hospital facilities and physician providers as product awareness increases.
Previous report
Total operating expenses decreased approximately $131,000 to approximately $3,520,000 comparing the year ended December 31, 2024 to the prior full year 2023 period. The decrease was attributable to decreases of (i) approximately $244,000 in compensation and benefits expense as salary costs related to sales related headcount decreased approximately $250,000 (ii) approximately $81,000 for credit losses provision, and (iii) approximately $35,000 in lease costs as we terminated the lease on our Florida office space in March 2024. These decreases were partially offset by increases of (i) approximately $195,000 in sales commission costs to independent sales representatives and (ii) approximately $55,000 in professional fees.
Reworded paragraphs (13)
Previous wording
Nuo is a regenerative therapies company developing and marketing products 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 or the patient’s own) biological therapies for tissue repair and regeneration is part of a transformative clinical strategy designed to improve long-term recovery in complex chronic conditions with significant unmet medical needs.
Current wording
Nuo is a commercial-stage medical device company focused on developing and marketing regenerative therapies 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 or the patient’s own) biological therapies for tissue repair and regeneration is part of a clinical strategy designed to improve long-term recovery in complex chronic conditions with significant unmet medical needs.
Previous wording
On March 31, 2025, we entered into a Distribution Agreement (the “Distribution Agreement”) with a U.S. affiliate of Smith & Nephew PLC ("Smith+Nephew"), a global medical technology company. Under the Distribution Agreement, we will supply Smith+Nephew with its own private label of our Aurix product. Although Smith+Nephew will be the sole and exclusive distributor in the United States of a private label Aurix product (the “Private Label product”), we have the ability and will continue to market, distribute, and sell our own Aurix branded product. The Distribution Agreement is for an initial term of five years and is renewable for additional two-year terms, subject to provisions for earlier termination.
Current wording
On March 31, 2025, we entered into the Distribution Agreement with Smith+Nephew, a global medical technology company. Although Smith+Nephew will be the sole and exclusive distributor in the United States of a private label Aurix product, we have the ability and will continue to market, distribute, and sell our own Aurix branded product.
Previous wording
Under the Distribution Agreement, Smith+Nephew will purchase Private Label product from us from time to time at agreed upon transfer pricing and we shall manufacture, package, and ship the Private Label product to Smith+Nephew’s customers in accordance with purchase orders and the Distribution Agreement. During the initial term of the Distribution Agreement commencing on the date of first sale by Smith+Nephew, minimum annual purchase commitments will apply to Smith+Nephew of an average of approximately $500,000 per year for Smith+Nephew to maintain exclusive distribution rights.
Current wording
Under the Distribution Agreement, Smith+Nephew will purchase Private Label product from us from time to time at agreed upon transfer pricing and we shall manufacture, package, and ship the Private Label product to Smith+Nephew’s customers in accordance with purchase orders and the Distribution Agreement. During the initial term of the Distribution Agreement commencing in October 2025, minimum annual purchase commitments will apply to Smith+Nephew of an average of approximately $500,000 per year for Smith+Nephew to maintain exclusive distribution rights.
Previous wording
As consideration for entering into the Distribution Agreement, Smith+Nephew will pay us up to $2,250,000 for distribution rights and in exchange for our establishment and maintenance of reimbursement in certain categories for the Aurix and the Private Label products. Such fees will be refundable to Smith+Nephew on a pro rata basis for the unexpired initial term of the Distribution Agreement if we do not comply with certain terms and conditions. A portion of the $2,250,000 was previously paid to us during the fiscal period ended March 31, 2025 in connection with entering into an exclusivity period to negotiate the Distribution Agreement.
Current wording
As consideration for entering into the Distribution Agreement, Smith+Nephew paid us an upfront distribution fee of $1,500,000 for distribution rights and we are also eligible to be paid by Smith+Nephew an additional $750,000 in fees based on our establishment and maintenance of reimbursement in certain categories for the Aurix and the Private Label products. These fees will be refundable to Smith+Nephew on a pro rata basis for the unexpired initial term of the Distribution Agreement if we do not comply with certain terms and conditions.
Previous wording
We believe that Smith+Nephew will need time to establish and begin commercial sales of its Private Label product. As a result, we anticipate limited sales under the Distribution Agreement during the next 12 months. While the Distribution Agreement will provide us with revenues, we also will incur expenses at the outset of the Distribution Agreement to enable us to comply with its provisions as well as packaging, shipping, and related costs associated with delivering the Private Label product for Smith+Nephew. The amount of these expenses and costs will vary depending on the amount of purchase orders that we receive from Smith+Nephew.
Current wording
We believe that Smith+Nephew will need time to establish full commercial sales of its Private Label product via its direct and indirect sales efforts. As a result, our revenues under the Distribution Agreement may increase modestly during the next 12 months. While the Distribution Agreement will provide us with revenues, we also will incur expenses under the Distribution Agreement to enable us to comply with its provisions as well as packaging, shipping, and related costs associated with delivering the Private Label product for Smith+Nephew. The amount of these expenses and costs will vary depending on the amount of purchase orders that we receive from Smith+Nephew.
Previous wording
Interest income, net for the year ended December 31, 2024 of approximately $100 represents net interest income from interest income on excess cash balances slightly in excess of interest expense attributable to the financing of insurance premiums. Interest expense, net for the year ended December 31, 2023 of approximately $3,200 represents the financing costs of insurance premiums in excess of interest income on reduced excess cash balances in 2023.
Current wording
Interest expense, net for the year ended December 31, 2025 of approximately $804 represents net interest expense attributable to the financing of insurance premiums income slightly in excess of interest income on excess cash balances. Conversely, interest income, net for the year ended December 31, 2024 of approximately $100 represents interest income on excess cash balances slightly in excess of interest expense attributable to the financing of insurance premiums.
Previous wording
Other income for the year ended December 31, 2024 primarily represents the gain of approximately $133,600 realized from the negotiated settlement of legacy accounts payable with third-party vendors including the full release of any ongoing payment liability.
Current wording
Other income for the year ended December 31, 2025 was nominal in amount. Other income for the year ended December 31, 2024 primarily represents the gain of approximately $133,600 realized from the negotiated settlement of legacy accounts payable with third-party vendors including the full release of any ongoing payment liability.
Previous wording
As of December 31, 2024, we had cash and cash equivalents of approximately $0.3 million, total current assets of approximately $0.8 million and total current liabilities of approximately $0.6 million. We have a history of losses and are not currently profitable. For the years ended December 31, 2024 and 2023, we incurred net losses of approximately $2.3 million and $3.2 million, respectively. As of December 31, 2024, our accumulated deficit was approximately $32.3 million and our stockholders’ equity was approximately $0.5 million.
Current wording
As of December 31, 2025, we had cash and cash equivalents of approximately $0.5 million, total current assets of approximately $1.4 million and total current liabilities of approximately $1.3 million. We have a history of losses and are not currently profitable. For the years ended December 31, 2025 and 2024, we incurred net losses of approximately $2.5 million and $2.3 million, respectively. As of December 31, 2025, our accumulated deficit was approximately $34.8 million and our stockholders’ deficit was approximately $1.0 million.
Previous wording
During the year ended December 31, 2024, we sold 2,000,000 shares of common stock to certain accredited investors pursuant to Securities Purchase Agreements in two private placements which closed in May and September 2024 for total proceeds of $1,500,000.
Current wording
During the year ended December 31, 2024, we sold 2,000,000 shares of common stock to certain accredited investors pursuant to Securities Purchase Agreements in two private placements which closed in May and September 2024 for total proceeds of $1,500,000. We issued 217,709 shares of common stock upon option exercises for gross proceeds of $90,417.
Previous wording
Cash used in operating activities for the year ended December 31, 2023 of approximately $3.2 million primarily reflects our net loss of approximately $3.2 million adjusted by an offsetting approximately $0.3 million net change in operating assets and liabilities and (i) approximately $0.1 million in total amortization of right of use assets, property and equipment depreciation, and stock-based compensation and (ii) approximately $0.2 million in combined provisions for credit losses and inventory obsolescence.
Current wording
Cash used in operating activities for the year ended December 31, 2025 of approximately $0.9 million primarily reflects our net loss of approximately $2.5 million adjusted by (i) the $1,275,000 increase in deferred revenues, (ii) approximately $0.2 million in total amortization of right of use assets, property and equipment depreciation, and stock-based compensation and (iii) approximately $0.1 million in combined provisions for credit losses and inventory obsolescence. The deferred revenue is due to the receipt of the $1.5 million upfront distribution fee from Smith+Nephew in conjunction with the private label distribution agreement which was effective as of March 31, 2025.
Previous wording
Cash used in operating activities for the year ended December 31, 2024 of approximately $2.2 million primarily reflects our net loss of approximately $2.3 million adjusted by the net effect of (i) approximately $0.2 million in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation, (iii) approximately $0.1 million in combined provisions for credit losses and inventory obsolescence partially offset by the approximately $0.1 million gain on settlement of legacy accounts payable balances.
Current wording
Cash used in operating activities for the year ended December 31, 2024 of approximately $2.2 million primarily reflects our net loss of approximately $2.3 million adjusted by the net effect of (i) approximately $0.2 million in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation, and (ii) approximately $0.1 million in combined provisions for credit losses and inventory obsolescence partially offset by the approximately $0.1 million gain on settlement of legacy accounts payable balances.
Previous wording
Cash used in investing activities for the year ended December 31, 2024 of approximately $155,000 primarily represents our purchase of centrifuge devices in the amount of approximately $151,000. We had limited investing activities of approximately $7,000 for the year ended December 31, 2023.
Current wording
Cash used in investing activities for the year ended December 31, 2024 of approximately $155,000 primarily represents approximately $151,000 in expenditures for the purchase of Aurix centrifuge devices.
Previous wording
See the discussion of Recent Accounting Developments inNote 2 - Liquidity and Summary of Significant Accounting Principles.
Current wording
See the discussion of Recent Accounting Developments inNote 2 - Liquidity and Summary of Significant Accounting Policies.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
During the year ended December 31, 2023, we sold 2,442,500 shares of common stock to certain accredited investors pursuant to Securities Purchase Agreements in two private placements which closed in August and December 2023 for proceeds of $1,997,500.
Previous report — wording carried elsewhere
Cash provided by financing activities for the year ended December 31, 2023 of approximately $2.0 million represents proceeds from two equity private placements that closed in August and December 2023.