Nuo Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Oct 30, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Oct 30, 2025
AURXStored price and day change unavailable
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-07-31.
0001437749-25-024043
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-10-30.
0001437749-25-032437
Item 2. 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 86 previous paragraphs and 86 current paragraphs.
67 unchanged; 15 reworded; 3 added; 3 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 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 (3)
Current report
Historically, we have used single suppliers for several components of the Aurix product line. We outsource the manufacturing of various product components to contract manufacturers. While we believe these manufacturers demonstrate competency, reliability and stability, there is no assurance that one or more of them will not experience an interruption or inability to provide us with the products needed to satisfy customer demand. Additionally, while most of the components of Aurix are generally readily available on the open market, a reagent, bovine thrombin, is available exclusively through Pfizer, with whom we have an existing supply agreement. Furthermore, we have historically sourced the ascorbic acid reagent component from a single supplier but have now established dual supply of this component.
Current report
Comparison of Nine Months Ended September 30, 2025 and 2024
Current report
Total revenues for the nine months ended September 30, 2025 totaled approximately $2,217,000 including $150,000 of license fee revenue related to the Smith+Nephew distribution agreement. Product revenues for the nine months ended September 30, 2025 totaled approximately $2,067,000 in comparison to product revenues of approximately $970,000 in the nine months ended September 30, 2024 representing an increase of approximately $1,096,000. Product revenues associated with the Smith+Nephew private label distribution arrangement were recognized for the first time in the three months ended September 30, 2025 consisted solely of centrifuge devices sold to Smith+Nephew in anticipation of their product launch. Associated gross profit was approximately $1,530,000 in the nine months ended September 30, 2025 in comparison to approximately $754,000 of gross profit in the nine months ended September 30, 2024. 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 discussed above and (iii) license fee revenue of $150,000 under the distribution agreement. Aggregate gross margin was approximately 69% in the nine months ended September 30, 2025 as compared to approximately 78% in the prior year’s nine-month period. The gross margin decline was primarily due to the 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 the license fee revenues having no associated cost.
Removed paragraphs (3)
Previous report
Comparison of Six Months Ended June 30, 2025 and 2024
Previous report
We had limited investing activities for the six months ended June 30, 2024.
Previous report
We did not have any financing activities for the six months ended June 30, 2025.
Reworded paragraphs (15)
Previous wording
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.
Current wording
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 nine months ended September 30, 2025, we recognized $150,000 of license revenue under the Distribution Agreement.
Previous wording
The description above of the Distribution Agreement is qualified by reference to the full text of such agreement, a copy of which was filed as Exhibit 10.1 to our Annual Report. The description above of the Amendment is qualified by reference to the full text of such agreement, a copy of which is filed as Exhibit 10.1 to this Quarterly Report and incorporated herein.
Current wording
The description above of the Amendment is qualified by reference to the full text of such agreement, a copy of which was filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q for the quarter ended June 30, 2025.
Previous wording
Total revenues for the three months ended June 30, 2025 totaled approximately $700,000 including $75,000 of license fee revenue related to the Smith+Nephew distribution agreement. Product revenues for the three months ended June 30, 2025 totaled approximately $625,000 in comparison to product and total revenues of approximately $365,000 in the three months ended June 30, 2024 representing an increase of approximately $335,000. Associated gross profit was approximately $541,000 in the three months ended June 30, 2025 in comparison to approximately $299,000 of gross profit in the three months ended June 30, 2024. The increase in revenues and gross profit was due primarily to an expanding customer base over the past year as hospital wound care facilities and providers become incrementally aware of the Aurix product and the 2021 Medicare NCD as well as the initial license fee revenue under the Smith+Nephew distribution agreement.
Current wording
Total revenues for the three months ended September 30, 2025 totaled approximately $1,032,000 including $75,000 of license fee revenue related to the Smith+Nephew distribution agreement. Product revenues for the three months ended September 30, 2025 totaled approximately $957,000 in comparison to product and total revenues of approximately $371,000 in the three months ended September 30, 2024 representing an increase of approximately $661,000. Product revenues associated with the Smith+Nephew private label distribution arrangement were recognized for the first time in the three months ended September 30, 2025 consisting solely of centrifuge devices sold to Smith+Nephew in anticipation of their product launch. Associated gross profit was approximately $625,000 in the three months ended September 30, 2025 in comparison to approximately $270,000 of gross profit in the three months ended September 30, 2024. 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 discussed above and (iii) license fee revenue under the distribution agreement. Aggregate gross margin was approximately 61% in the quarter as compared to approximately 73% in the prior year’s quarter. The gross margin decline was primarily due to the 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 the license fee revenues having no associated cost.
Previous wording
Total operating expenses increased approximately $352,000 to approximately $1,193,000 comparing the three months ended June 30, 2025 to the three months ended June 30, 2024. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $129,000 due largely to increased legal and accounting fees associated with the finalization of the distribution agreement with Smith+Nephew and SEC registration statements filed in the quarter, (ii) third party commission expense of approximately $68,000 for independent sales representatives and distributors resulting from increased Aurix product revenues , and (iii) third party consulting expenses of approximately $63,000 primarily for our quality management system and reimbursement support services.
Current wording
Total operating expenses increased approximately $318,000 to approximately $1,166,000 comparing the three months ended September 30, 2025 to the three months ended September 30, 2024. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $91,000 due largely to the combination of increased consulting expenses for our quality management systems and reimbursement support services and legal and accounting fees (ii) third party commission expense of approximately $86,000 for independent sales representatives and distributors resulting from increased Aurix product revenues , and (iii) compensation and benefit costs of approximately $74,000 attributable to added sales management personnel.
Previous wording
Other income (expense), net for the three months ended June 30, 2025 and 2024 primarily represents interest income on cash balances in excess of interest expense associated with the financing of insurance premiums while other income for the three-month periods was nominal.
Current wording
Other income (expense), net for the three months ended September 30, 2025 and 2024 primarily represents modest interest income on cash balances in excess of interest expense associated with the financing of insurance premiums while other income for the three-month periods was nominal.
Previous wording
Total operating expenses increased approximately $567,000 to approximately $2,301,000 comparing the six months ended June 30, 2025 to the six months ended June 30, 2024. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $199,000 due largely to increased legal and accounting fees associated with the negotiation and finalization of the Smith+Nephew distribution agreement and SEC registration statements filed in the period, (ii) third party commission expense of approximately $135,000 for independent sales representatives and distributors resulting from increased Aurix product revenues, and (iii) third party consulting expenses of approximately $83,000 primarily for our quality management system and reimbursement support services.
Current wording
Total operating expenses increased approximately $884,000 to approximately $3,467,000 comparing the nine months ended September 30, 2025 to the nine months ended September 30, 2024. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $374,000 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 in the nine-month period and consulting expenses for our quality management system and reimbursement support services and legal (ii) third party commission expense of approximately $221,000 for independent sales representatives and distributors resulting from increased Aurix product revenues, and (iii) compensation and benefit costs of approximately $154,000 attributable primarily to added sales management personnel.
Previous wording
Other income (expense), net for the six months ended June 30, 2025 primarily represents interest expense associated with the financing of insurance premiums in excess of interest income on cash balances while other income for the six-month periods was nominal.
Current wording
Other income (expense), net for the nine months ended September 30, 2025 primarily represents interest expense associated with the financing of insurance premiums in excess of interest income on cash balances while other income for the nine-month periods was nominal.
Previous wording
As of June 30, 2025, we had cash balances of approximately $0.3 million, total current assets of approximately $0.9 million and total current liabilities of approximately $1.0 million. As an operational business, 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 June 30, 2025, our accumulated deficit was approximately $33.6 million and our stockholders’ deficit was approximately $0.8 million.
Current wording
As of September 30, 2025, we had cash balances of approximately $0.5 million, total current assets of approximately $1.5 million and total current liabilities of approximately $1.3 million. As an operational business, 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 September 30, 2025, our accumulated deficit was approximately $34.2 million, and our stockholders’ deficit was approximately $0.4 million.
Previous wording
During the six-month period ended June 30, 2025, we received $1.5 million from Smith+Nephew representing the upfront distribution fee under the Distribution Agreement.
Current wording
During the three-month period ended September 30, 2025, we sold 527,612 shares of common stock to certain accredited investors pursuant to a Securities Purchase Agreement which closed in July for total proceeds of $791,418. We also received proceeds of $113,541 from the exercise of common stock options during the three-month period ended September 30, 2025. During the nine-month period ended September 30, 2025, we received $1.5 million from Smith+Nephew representing the upfront distribution fee under the Distribution Agreement.
Previous wording
Effective January 1, 2024, pursuant to the provisions of the August 2022 Common Stock and Warrant Purchase Agreement with Pacific Medical, Inc. ("Pacific Med"), we issued Pacific Med a warrant to purchase up to 500,000 shares of common stock at a price equal to $0.56, the 20-day volume weighted average closing price per share of our common stock ending December 31, 2023. A portion of the warrant was exercised during the six-month period ended June 30, 2024 and we received proceeds of $151,200.
Current wording
Effective January 1, 2024, pursuant to the provisions of the August 2022 Common Stock and Warrant Purchase Agreement with Pacific Medical, Inc. ("Pacific Med"), we issued Pacific Med a warrant to purchase up to 500,000 shares of common stock at a price equal to $0.56, the 20-day volume weighted average closing price per share of our common stock ending December 31, 2023. A portion of the warrant was exercised during the nine-month period ended September 30, 2024 and we received proceeds of $151,200.
Previous wording
Cash provided by operating activities for the six months ended June 30, 2025 of approximately $264,000 primarily reflects our net loss of approximately $1,396,000 adjusted by (i) the $1,425,000 increase in deferred revenues (ii) approximately $83,000 net change in operating assets and liabilities (excluding deferred revenue), and (iii) approximately $116,000 in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation. 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.
Current wording
Cash used in operating activities for the nine months ended September 30, 2025 of approximately $442,000 primarily reflects our net loss of approximately $1,934,000 adjusted by (i) the $1,350,000 increase in deferred revenues and (ii) approximately $177,000 in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation. 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 six months ended June 30, 2024 of approximately $1,254,000 primarily reflects our net loss of approximately $1,249,000 adjusted by (i) approximately $76,000 net change in operating assets and liabilities, (ii) approximately $53,600 total depreciation and amortization expense and stock-based compensation expense and (iii) a provision for credit losses of $17,500.
Current wording
Cash used in operating activities for the nine months ended September 30, 2024 of approximately $1,741,000 primarily reflects our net loss of approximately $1,827,000 adjusted by (i) approximately $94,900 total depreciation and amortization expense and stock-based compensation expense and (ii) a provisions for credit losses and inventory obsolescence totaling $47,500.
Previous wording
Cash used in investing activities for the six months ended June 30, 2025 primarily represents $220,000 in expenditures for the purchase of centrifuge devices.
Current wording
Cash used in investing activities for the nine months ended September 30, 2025 and 2024 primarily represents approximately $220,000 and $150,000 in expenditures, respectively, for the purchase of Aurix centrifuge devices.
Previous wording
Cash from financing activities for the six months ended June 30, 2024 reflects proceeds of (i) $650,875 from the sale of 867,833 shares of common stock in a private placement closed in May 2024 and (ii) $151,200 from the exercise of 270,000 warrants in June 2024.
Current wording
Cash provided by financing activities for the nine months ended September 30, 2024 reflects proceeds of (i) $1,500,000 from the sale of 2,000,000 shares of common stock in two private placements which closed in May and September 2024 and (ii) $151,200 from the exercise of 270,000 warrants in June 2024.
Previous wording
Our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report are prepared in conformity with U.S. GAAP, which require us to make estimates and assumptions regarding future events that affect the amounts reported in our financial statements and accompanying notes. We base these estimates on our experience and assumptions regarding future events we believe to be reasonable under the circumstances. Actual results could differ from those estimates and such differences may be material to the unaudited condensed consolidated financial statements. We have described our most critical accounting policies in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of our Annual Report. There were no accounting policies identified as critical. There have been no material changes to our critical accounting policies or estimates since December 31, 2024.
Current wording
Our unaudited consolidated financial statements included in Part I, Item 1 of this Quarterly Report are prepared in conformity with U.S. GAAP, which require us to make estimates and assumptions regarding future events that affect the amounts reported in our financial statements and accompanying notes. We base these estimates on our experience and assumptions regarding future events we believe to be reasonable under the circumstances. Actual results could differ from those estimates and such differences may be material to the unaudited consolidated financial statements. Consistent with the disclosure in our Annual Report for the year December 31, 2024, there are no accounting policies identified as critical.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Cash provided by financing activities for the nine months ended September 30, 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 and (ii) $113,541 from the exercise of common stock options.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
Total revenues for the six months ended June 30, 2025 totaled approximately $1,184,000 including $75,000 of license fee revenue related to the Smith+Nephew distribution agreement. Product revenues for the six months ended June 30, 2025 totaled approximately $1,109,000 in comparison to product revenues of approximately $599,000 in the six months ended June 30, 2024 representing an increase of approximately $511,000. Associated gross profit was approximately $904,000 in the six months ended June 30, 2025 in comparison to approximately $483,000 of gross profit in the six months ended June 30, 2024. The increase in revenues and gross profit was due to an expanding customer base over the past year as hospital wound care facilities and providers become incrementally aware of the Aurix product and the 2021 Medicare NCD as well as the initial license fee revenue under the Smith+Nephew distribution agreement.