aurx20260930

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the Quarterly Period Ended September 30, 2026

☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ________ to ________

Commission file number 000-28443

Nuo Therapeutics, Inc.

(Exact Name of Registrant as Specified in its Charter)

Delaware	23-3011702
(State or Other Jurisdiction of Incorporation or Organization)	(IRS Employer Identification No.)

8285 El Rio, Suite 190
Houston, TX 77054

(Address of Principal Executive Offices) (Zip Code)

(346) 396-4770

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act: None

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large Accelerated Filer ☐	Accelerated Filer ☐
Non-accelerated Filer ☒	Smaller Reporting Company ☒
	Emerging Growth Company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

APPLICABLE ONLY TO CORPORATE ISSUERS

As of November 12, 2026, the number of shares outstanding of the registrant’s common stock, $0.0001 par value, was 48,585,593.

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NUO THERAPEUTICS, INC.

TABLE OF CONTENTS

	Page
PART I. FINANCIAL INFORMATION

Item 1. Unaudited Consolidated Financial Statements	1

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	17

Item 3. Quantitative and Qualitative Disclosures About Market Risk	25

Item 4. Controls and Procedures	25

PART II. OTHER INFORMATION

Item 1. Legal Proceedings	27

Item 1A. Risk Factors	27

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	27

Item 3. Defaults Upon Senior Securities	28

Item 4. Mine Safety Disclosures	28

Item 5. Other Information	28

Item 6. Exhibits	28

Signatures	29

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PART I

FINANCIAL INFORMATION

Item 1. Consolidated Financial Statements

NUO THERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEETS

(Unaudited)

	September 30, 2026			December 31, 2025
ASSETS
Current assets
Cash	$	80,941		$	548,946
Accounts receivable, net		1,410,322			561,667
Inventory, net		330,134			213,761
Prepaid expenses and other current assets		162,667			55,509
Total current assets		1,984,064			1,379,883

Property and equipment, net		704,903			366,315
Operating lease right of use assets		41,238			99,464
Total assets	$	2,730,205		$	1,845,662

LIABILITIES AND STOCKHOLDERS' DEFICIT
Current liabilities
Accounts payable	$	756,720		$	436,083
Accrued expenses		648,177			493,792
Deferred revenue		380,730			300,000
Current portion of notes payable		515,625			-
Current portion of notes payable – related party		112,500			-
Current portion of operating lease liabilities		40,756			76,410
Total current liabilities		2,454,508			1,306,285

Deferred revenue – long term		951,826			975,000
Notes payable		961,875			300,000
Note payable – related party		210,500			200,000
Non-current portion of operating lease liabilities		-			20,936
Total liabilities		4,578,709			2,802,221

Commitments and contingencies (Note 10)

Stockholders' deficit
Common stock; $0.0001 par value, 100,000,000 shares authorized, 48,573,894 and 48,179,039 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively		4,857			4,818
Additional paid-in capital		34,239,796			33,810,785
Accumulated deficit		(36,093,157	)		(34,772,162	)
Total stockholders' deficit		(1,848,504	)		(956,559	)

Total liabilities and stockholders' deficit	$	2,730,205		$	1,845,662

See accompanying notes to unaudited consolidated financial statements.

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NUO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	Three Months ended September 30, 2026			Three Months ended September 30, 2025
Revenue
Product sales	$	1,779,563		$	957,096
Distribution fee revenue		86,562			75,000
Total revenue		1,866,125			1,032,096

Costs of sales		673,334			406,721
Gross profit		1,192,791			625,375

Operating expenses
Selling, general and administrative		1,567,223			1,165,517
Total operating expenses		1,567,223			1,165,517

Loss from operations		(374,432	)		(540,142	)

Other income (expense)
Interest income (expense), net		(51,099	)		409
Other income		603			1,814
Total other income (expenses)		(50,496	)		2,223

Net loss	$	(424,928	)	$	(537,919	)

Loss per common share
Basic and diluted	$	(0.01	)	$	(0.01	)

Weighted average common shares outstanding
Basic and diluted		48,472,374			47,539,384

See accompanying notes to unaudited consolidated financial statements.

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NUO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	Nine Months ended September 30, 2026			Nine Months ended September 30, 2025
Revenue
Product sales	$	4,694,782		$	2,066,679
Distribution fee revenue		242,444			150,000
Total revenue		4,937,226			2,216,679

Costs of sales		1,724,681			687,092
Gross profit		3,212,545			1,529,587

Operating expenses
Selling, general and administrative		4,199,995			3,466,898
Total operating expenses		4,199,995			3,466,898

Loss from operations		(987,450	)		(1,937,311	)

Other income (expense)
Interest income (expense), net		(340,447	)		(33	)
Other income		6,902			3,608
Total other income (expenses)		(333,545	)		3,575

Net loss	$	(1,320,995	)	$	(1,933,736	)

Loss per common share
Basic and diluted	$	(0.03	)	$	(0.04	)

Weighted average common shares outstanding
Basic and diluted		48,389,216			47,062,186

See accompanying notes to unaudited consolidated financial statements.

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NUO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)

(Unaudited)

For the Nine Months Ended September 30, 2026 and 2025

	Common Stock
	Shares		Amount (par $0.0001)		Additional Paid-In Capital			Accumulated Deficit			Stockholders' Deficit
Balance, January 1, 2026		48,179,039	$	4,818	$	33,810,785		$	(34,772,162	)	$	(956,559	)
Stock compensation expense		-		-		23,527			-			23,527
Issuance of common stock for cashless option exercise		99,619		10		(10	)		-			-
Issuance of common stock for services provided		10,638		1		17,999			-			18,000
Issuance of warrants in connection with notes payable issuance		-		-		149,635			-			149,635
Net loss		-		-		-			(618,466	)		(618,466	)
Balance, March 31, 2026		48,289,296	$	4,829	$	34,001,936		$	(35,390,628	)	$	(1,383,863	)
Stock compensation expense		-		-		41,490			-			41,490
Issuance of common stock for cashless option exercise		111,194		11		(11	)		-			-
Issuance of common stock for services provided		18,034		2		20,998			-			21,000
Issuance of warrants in connection with notes payable issuance		-		-		63,660			-			63,660
Net loss		-		-		-			(277,601	)		(277,601	)
Balance, June 30, 2026		48,418,524	$	4,842	$	34,128,073		$	(35,668,229	)	$	(1,535,314	)
Stock compensation expense		-		-		89,238			-			89,238
Issuance of common stock for cashless option exercise		133,181		13		(13	)		-			-
Issuance of common stock for services provided		22,189		2		22,498			-			22,500
Net loss		-		-		-			(424,928	)		(424,928	)
Balance, September 30, 2026		48,573,894	$	4,857	$	34,239,796		$	(36,093,157	)	$	(1,848,504	)

	Common Stock
	Shares		Amount (par $0.0001)		Additional Paid-In Capital			Accumulated Deficit			Stockholders’ Equity/ (Deficit)
Balance, January 1, 2025		46,816,114	$	4,682	$	32,768,976		$	(32,259,946	)	$	513,712
Stock compensation expense		-		-		19,343			-			19,343
Net loss		-		-		-			(746,128	)		(746,128	)
Balance, March 31, 2025		46,816,114	$	4,682	$	32,788,319		$	(33,006,074	)	$	(213,073	)
Stock compensation expense		-		-		23,201			-			23,201
Issuance of common stock for services provided		10,364		1		14,999			-			15,000
Net loss		-		-		-			(649,689	)		(649,689	)
Balance, June 30, 2025		46,826,478	$	4,683	$	32,826,519		$	(33,655,763	)	$	(824,561	)
Issuance of common stock for cash proceeds		527,612		53		791,365			-			791,418
Issuance of common stock for option exercises		283,853		28		113,513			-			113,541
Issuance of common stock for cashless option exercises		231,436		23		(23	)		-			-
Stock compensation expense		-		-		19,915			-			19,915
Issuance of common stock for services provided		11,742		1		17,999			-			18,000
Net loss		-		-		-			(537,919	)		(537,919	)
Balance, September 30, 2025		47,881,121	$	4,788	$	33,769,288		$	(34,193,682	)	$	(419,606	)

See accompanying notes to unaudited consolidated financial statements.

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NUO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	For the Nine Months Ended September 30,
	2026			2025
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(1,320,995	)	$	(1,933,736	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation expense		89,066			61,551
Stock-based compensation		154,255			62,459
Non-cash interest expense		338,795			-
Provision for credit losses		73,960			41,401
Provision for inventory obsolescence		-			9,119
Vendor expense settled in shares		61,500			33,000
Amortization of operating lease right of use assets		58,226			52,978
Changes in operating assets and liabilities:
Accounts receivable, net		(927,511	)		(445,448	)
Inventory, net		(116,373	)		(60,304	)
Prepaid expenses and other current assets		(107,158	)		65,208
Accounts payable		320,637			272,469
Accrued expenses		159,281			98,492
Deferred revenue		57,556			1,350,000
Operating lease liabilities		(56,590	)		(49,514	)
Net cash used in operating activities		(1,215,351	)		(442,325	)

CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment		(427,654	)		(231,551	)
Net cash used in investing activities		(427,654	)		(231,551	)

CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of notes payable		1,175,000			-
Net proceeds from issuance of common stock		-			791,418
Net proceeds from option exercises		-			113,541
Net cash provided by financing activities		1,175,000			904,959

NET INCREASE (DECREASE) IN CASH		(468,005	)		231,083
Cash, beginning of period		548,946			283,714
Cash, end of period	$	80,941		$	514,797


SUPPLEMENTAL INFORMATION
Cash paid during the period for interest expense	$	1,613		$	3,525

NON-CASH INVESTING AND FINANCING TRANSACTIONS
Issuance of common stock for cashless option exercise	$	34		$	23
Offset of accounts receivable against accrued expenses	$	4,896		$	-

See accompanying notes to unaudited consolidated financial statements.

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NUO THERAPEUTICS, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

(Unaudited)

Note 1 – Description of Business

Description of Business

Nuo Therapeutics, Inc. (“Nuo Therapeutics,” the “Company,” “we,” “us,” or “our”) 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 Section 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the AutoloGel™ System, now known as the Aurix System (“Aurix”), for processing peripheral blood into an autologous platelet rich plasma ("PRP") for wound management. In 2010, Cytomedix acquired the Angel Whole Blood Separation System from Sorin Group USA, Inc. In 2012, Cytomedix acquired Aldagen, Inc. (“Aldagen”), a privately held developmental cell-therapy company. Aldagen remains a non-operational, wholly owned subsidiary of the Company.

In 2014, Cytomedix changed its name to Nuo Therapeutics, Inc. In 2016, Nuo filed for and emerged from bankruptcy under a Chapter 11 Plan of Reorganization. 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. In April 2021, CMS issued a favorable National Coverage Determination (“NCD”) for autologous PRP products and Nuo restarted business activities in October 2021. Nuo's principal offices are located in Houston, Texas.

Note 2 – Liquidity and Summary of Significant Accounting Policies

Liquidity

Since our inception, we have financed our operations by raising debt, issuing equity and equity-linked instruments, and executing licensing arrangements, and to a lesser extent by generating royalties and product revenues. In mid-2019, we ceased ongoing operational activities as we worked to reach a favorable outcome to Medicare reimbursement coverage for the Aurix System. In April 2021, CMS issued an NCD mandating national reimbursement coverage for Aurix when used in chronic non-healing wounds where a clinical diagnosis of diabetes exists for the patient. During the year ended December 31, 2025, we received an upfront distribution fee of $1.5 million from Smith+Nephew in conjunction with the private label distribution agreement (See Note 4 – Distribution Agreement with Smith+Nephew). We also sold 527,612 shares of common stock to certain accredited investors pursuant to a Security Purchase Agreement which closed on July 30, 2025 and received $113,541 from the exercise of options. On December 31, 2025, we received pre-funded proceeds of $500,000 related to the issuance of secured notes payable which officially closed in January 2026 in the total amount of $1,000,000 upon the receipt of an additional $500,000 in note proceeds. In May 2026, we received $675,000 for the issuance of additional secured notes payable in an interim funding. Subsequent to September 30, 2026, we received $325,000 for the issuance of additional secured notes in a final closing of the total commitments under the note purchase agreement (see Note 11 – Subsequent Events for additional information). Finally, we received an additional $50,000 distribution fee in January 2026 in conjunction with an amendment to the distribution agreement and a $250,000 reimbursement fee milestone in August 2026 upon confirmation of establishment of reimbursement coverage in an additional place of service category.

We have incurred, and continue to incur, recurring losses. As of September 30, 2026, we have an accumulated deficit of approximately $36.1 million and cash of approximately $0.1 million.

The accompanying unaudited consolidated financial statements have been prepared assuming that we will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business. The propriety of using the going-concern basis is dependent upon, among other things, the achievement of future profitable operations, the ability to generate sufficient cash from operations, and potential other funding sources, including cash on hand, to meet our obligations as they become due.

We believe based on the operating cash requirements and capital expenditures expected for the next twelve months that our current resources and projected revenue from sales of Aurix products and the Private Label product to Smith+Nephew are insufficient to support our operations for the next 12 months from the date these financial statements are issued. As such, we believe that substantial doubt about our ability to continue as a going concern exists. In response to these conditions, management is actively pursuing plans to mitigate these liquidity constraints, which include the October 2026 Second Funding (see Note 11 – Subsequent Events for additional information) and securing additional equity financing; however, there can be no assurance that management's plans will be successful. The unaudited consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

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Even assuming we succeed in raising sufficient additional funds, we require additional capital and may seek to continue financing our operations with external capital for the foreseeable future. Any equity financing may cause further substantial dilution to our stockholders and could involve the issuance of securities with rights senior to the common stock. Any additional debt financing may require us to comply with additional onerous financial covenants and restrict our business operations. Our ability to complete additional financings is dependent on, among other things, market reception of the Company and perceived likelihood of success of our business model, the state of the capital markets at the time of any proposed equity or debt offering, state of the credit markets at the time of any proposed loan financing, and on the relevant transaction terms, among other things. We may not be able to obtain additional capital as required to finance our efforts, through equity or debt financing, other transactions, or any combination thereof, on satisfactory terms or at all. Additionally, any such financing, if at all obtained, may not be adequate to meet our capital needs and to support our operations.

Basis of Presentation and Principles of Consolidation

The accompanying interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and should be read in conjunction with the financial statements and notes thereto included in our Annual Report on Form 10-K for the year ended December 31, 2025, which was filed with the Securities and Exchange Commission (“SEC”) on March 30, 2026. Certain information and footnote disclosures normally included in the consolidated financial statements prepared in accordance with U.S. GAAP have been omitted from this report on Form 10-Q pursuant to the rules and regulations of the SEC.

Results for the interim periods in this report are not necessarily indicative of future financial results and have not been audited by our independent registered public accounting firm. In the opinion of management, the accompanying unaudited consolidated financial statements include all adjustments necessary to present fairly our interim consolidated financial statements as of September 30, 2026, and for the nine months ended September 30, 2026 and 2025. These adjustments are of a normal recurring nature and are consistent with the adjustments recorded to prepare the annual audited consolidated financial statements as of December 31, 2025.

The unaudited consolidated financial statements include the accounts of the Company and its wholly owned, controlled, and inactive subsidiary Aldagen, Inc. (“Aldagen”). All inter-company accounts and transactions are eliminated in consolidation. The Company operates its business in one operating segment consisting of one reporting unit.

Use of Estimates

The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amount of revenues and expenses during the reporting period. In the accompanying unaudited consolidated financial statements, estimates are used for, but not limited to stock-based compensation, recoverability and depreciable lives of long-lived assets, the fair value of the secured notes under the fair value option, deferred taxes, and associated valuation allowance and allowances for inventory obsolescence and credit losses. Actual results could differ from those estimates.

Credit Concentration

We generate accounts receivable from the sale of our products. Specific customer receivable balances in excess of 10% of total receivables at September 30, 2026 and December 31, 2025 is listed below.

September 30,

2026

December 31,

2025

Customer A

24%

19%

Revenue from significant customers exceeding 10% of total revenues for the three and nine months ended September 30, 2026 and 2025 is listed below. All our revenue for both periods was generated within the U.S.

Three

Months

Ended

September

30,

2026

Three

Months

Ended

September

30,

2025

Nine

Months

Ended

September

30,

2026

Nine

Months

Ended

September

30,

2025

Customer A

30%

32%

27%

18%

Customer B

10%

* less than 10%

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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.

Cash

When applicable, we consider all highly liquid instruments purchased with an original maturity of three months or less to be cash equivalents. We maintain our cash in the form of money market deposit accounts with financial institutions that we believe are credit worthy.

Accounts Receivable, net

We generate accounts receivable from the sale of the Aurix products and sales made to Smith+Nephew under the Distribution Agreement. Accounts receivable as of September 30, 2026 and December 31, 2025 reflect customer receivables from commercial sales activities.

We provide for an allowance against receivables for estimated losses that may result from a customer’s inability or unwillingness to pay. We estimate credit losses expected over the life of our trade receivables and contract assets based on historical information combined with current conditions that may affect a customer’s ability to pay and reasonable and supportable forecasts. While the Company uses various credit quality metrics, it primarily monitors collectability by reviewing the duration of collection pursuits on its delinquent trade receivables and historical write-off trends. Based on the Company’s experience, the customer's delinquency status, which is analyzed periodically, is the strongest indicator of the credit quality of the underlying trade receivables. Accounts are written off against the allowance for credit losses when we determine that amounts are not collectable. Recoveries of previously written-off accounts are recorded when collected. For the three-month and nine-month periods ending September 30, 2026, we recorded a $73,960 provision for credit losses. Receivables of approximately $74,000 were written off in the three and nine month periods ending September 30, 2026. For the three-month and nine-month periods ending September 30, 2025, we recorded provisions for credit losses of $28,876 and $41,401, respectively. As of September 30, 2026 and December 31, 2025, the allowance for credit losses was $95,000 and $90,000, respectively.

Inventory, net

Our inventory is produced by third-party manufacturers and consists of raw materials and finished goods. Inventory cost is determined on a first-in, first-out basis and is stated at the lower of cost or net realizable value. We maintain an inventory of kits, reagents, and other disposables having shelf-lives that generally range from 12 months to two years.

As of September 30, 2026, our inventory consisted of approximately $150,000 of finished goods inventory and approximately $180,000 of raw materials acquired to facilitate the manufacturing of finished goods at our contract manufacturer and our warehouse/distribution facility. As of December 31, 2025, our inventory consisted of approximately $139,000 of finished goods inventory and approximately $75,000 of raw materials.

We provide for an allowance against inventory for estimated losses that may result in excess and obsolete inventory (i.e., from the expiration of products). Our allowance for expired inventory is estimated based upon the inventory’s remaining shelf-life and our anticipated ability to sell such inventory, which is estimated using past experience and future forecasts, within its remaining shelf life. Expired products are segregated and used for demonstration purposes only; we record the associated expense for this reserve to cost of sales in the consolidated statements of operations. For the three-month and nine-month periods ending September 30, 2026, we recorded no provision for inventory obsolescence. For the three-month and nine-month periods ending September 30, 2025, we recorded a provision for inventory obsolescence of zero and $9,119, respectively. We maintained a reserve for inventory obsolescence as of September 30, 2026 and December 31, 2025 of $10,000.

Property and Equipment, net

Property and equipment is stated at cost less accumulated depreciation. Assets are depreciated, using the straight-line method, over their estimated useful life ranging from one to five years. Maintenance and repairs are charged to operations as incurred. On at least an annual basis, management determines if there are any depreciating assets that are no longer in use. If there are, the residual balances of such assets are considered impaired.

Leases

At the inception of a contract, we determine if the arrangement is, or contains, a lease. Right-of-use (“ROU”) assets represent our right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date based on the present value of lease payments over the lease term. Rent expense is recognized on a straight-line basis over the lease term.

We have made certain accounting policy elections whereby we (i) do not recognize ROU assets or lease liabilities for short-term leases (those with original terms of 12-months or less) and (ii) combine lease and non-lease elements of any operating leases.

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Revenue Recognition

We analyze our revenue arrangements to determine the appropriate revenue recognition using the following steps: (i) identification of contracts with customers; (ii) identification of distinct performance obligations in the contract; (iii) determination of contract transaction price; (iv) allocation of contract transaction price to the performance obligations; and (v) determination of revenue recognition based on timing of satisfaction of the performance obligation. We recognize revenues upon the satisfaction of the performance obligations (upon transfer of control of promised goods or services to customers) in an amount that reflects the consideration to which we expect to be entitled in exchange for those goods or services. In certain instances where the revenue is variable and we cannot estimate the amount of consideration to which we expect to be entitled, we are constrained from initially recognizing revenue. In these cases, once the estimate is no longer constrained, we recognize revenue in the amount of consideration to which we expect to be entitled.

We provide for the sale of our products, including disposable processing sets and supplies through our distribution agreements and directly to customers. Revenue from the sale of products is recognized upon shipment of products to the customers. We do not maintain a reserve for returned products, as in the past those returns have not been material and are not expected to be material in the future. Direct costs associated with product sales are recorded at the time that revenue is recognized.

For the three months ended September 30, 2026, total product revenues are disaggregated between Aurix and Private Label kits of approximately $1,591,000 and Private Label centrifuge devices of approximately $189,000, respectively. For the nine months ended September 30, 2026, total product revenues are disaggregated between Aurix and Private Label kits of approximately $4,357,000 and Private Label centrifuge devices of approximately $338,000, respectively. All product revenue is recognized at a point in time.

Our distribution agreement with Smith+Nephew (See Note 4 – Distribution Agreement with Smith + Nephew for additional information) provides for an upfront distribution fee which will be recognized over time as revenue ratably on a straight-line basis over the initial 5-year term of the agreement. As of September 30, 2026, the total fees applicable to the remaining performance obligations are approximately $1.3 million and will be fully recognized as of March 31, 2030. The sale to Smith+Nephew of the private label Aurix product is a bill and hold arrangement whereby Nuo is responsible for the fulfillment of Smith+Nephew customer orders. Revenue recognition under bill and hold arrangements occurs at the point in time when control of the goods transfers to the customer (Smith+Nephew). The satisfaction of certain criteria is required to demonstrate the customer has obtained control of the goods.

Stock-Based Compensation

The fair value of employee stock options is measured at the date of grant. Expected volatility for options is based on the equally weighted average historical volatility from comparable public companies with an expected term consistent with ours. Expected years until exercise represents the period of time that options are expected to be outstanding. The risk-free rate for periods within the expected life of the option is based on the U.S. Treasury yield curve in effect at the time of grant. We recognize forfeitures of stock-based awards as they occur. We estimate that the dividend rate on our common stock will be zero. The assumptions are summarized in the following table:

	Nine Months Ended September 30, 2026				Nine Months Ended September 30, 2025
Risk free rate		4.17	-	4.19%		3.86%	-	4.06%
Weighted average expected years until exercise		5.5				5.5
Expected stock volatility		75%				75%
Dividend yield		-				-

Income Taxes

We account for income taxes using the asset and liability method. Under the asset and liability method, current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. Tax rate changes are reflected in income during the period such changes are enacted. We measure our deferred tax assets and liabilities using the enacted tax rates that we believe will apply in the years in which the temporary differences are expected to be recovered or paid.

A deferred income tax asset or liability is recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and tax credits and loss carryforwards. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. All of our tax years remain subject to examination by the tax authorities.

Our policy for recording interest and penalties associated with audits is to record such items as a component of income before taxes. There were no such items in the three and nine months ended September 30, 2026 and 2025.

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Fair Value Measurements

Our consolidated balance sheets may include certain financial instruments that are carried at fair value. Fair value is the price that would be received from the sale of an asset or paid to transfer a liability assuming an orderly transaction in the most advantageous market at the measurement date. U.S. GAAP establishes a hierarchical disclosure framework which prioritizes and ranks the level of observability of inputs used in measuring fair value. These tiers include:

●	Level 1, defined as observable inputs such as quoted prices in active markets for identical assets;

●	Level 2, defined as observable inputs other than Level 1 prices such as quoted prices for similar assets; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and
●	Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions.

An asset or liability’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, if applicable, we perform a detailed analysis of our assets and liabilities that are measured at fair value. All assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3.

Debt - Election of Fair Value Option

We have elected to account for the Secured Promissory Notes issued in 2026 (see Note 6 - Secured Promissory Notes for further information) under the fair value option (see Note 8 – Fair Value). Accordingly, we recorded the Secured Promissory Notes at their fair values on the date of issuance and will remeasure the fair value at each subsequent balance sheet date with the change being recognized as interest expense in the statement of operations. All unpaid accrued interest is included in the determination of fair value and changes thereto. All debt issuance costs related to the Secured Promissory Notes accounted for at fair value are expensed as incurred.

Debt Modifications and Extinguishments

We evaluate amendments, refinancing, or modifications of our debt arrangements to determine whether the transaction should be accounted for as a modification or an extinguishment of the existing debt. This determination is based on a comparison of the present value of the cash flows under the terms of the new debt instrument with the present value of the remaining cash flows under the terms of the original debt instrument (commonly referred to as the 10% test). When the difference between the present value of the old and new cash flows is less than 10%, the transaction is accounted for as a modification (continuation) of the existing debt.

Basic and Diluted Loss per Share

In periods of net loss, basic loss per share is computed by dividing net loss available to common stockholders by the weighted average number of shares of common stock outstanding during the period. In periods of net loss, diluted loss per share is calculated similarly to basic loss per share because the impact of all potential dilutive common shares is anti-dilutive.

For periods of net income, diluted earnings per share is computed using the more dilutive of the “treasury method” or “two class method.” Dilutive earnings per share under the “treasury method” is calculated by dividing net income available to common stockholders by the weighted-average number of shares outstanding plus the dilutive impact of all potential dilutive common shares, consisting primarily of common shares underlying common stock options and stock purchase warrants using the treasury stock method, and convertible notes using the if-converted method. Because none of the Company’s currently outstanding equity-linked financial instruments contain non-forfeitable rights to dividends, the “two class” method results in the same diluted earnings per share as the “treasury method.”

All of our potential dilutive securities are considered anti-dilutive for the nine months ended September 30, 2026 and 2025. The following table sets forth the potential dilutive securities excluded from the calculation of diluted loss per share for the periods presented.

	Nine Months Ended September 30, 2026		Nine Months Ended September 30, 2025

Shares underlying:

Common stock options		2,488,082		2,850,582
Stock purchase warrants		361,665		200,000
Performance shares		-		300,000
		2,849,747		3,350,582

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Segment Information

Operating segments are defined as components of an enterprise (business activity from which it earns revenue and incurs expenses) for which discrete financial information is available and regularly reviewed by the chief operating decision maker ("CODM") in deciding how to allocate resources and in assessing performance. The Company’s CODM is its Chief Executive and Financial Officer. The Company views its operations and manages its business as a single operating and reporting segment. All the Company’s long-lived assets are in the United States.

Recent Accounting Developments

In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses (DISE), which applies to all public business entities. This standard is effective for annual reporting periods beginning after December 15, 2026, with early adoption permitted. We are assessing the effect of this standard on our consolidated financial statements and related disclosures.

In December 2025, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2025-11, Interim Reporting (Topic 270): Narrow-Scope Improvements, which clarifies the applicability of the interim reporting guidance, the types of interim reporting, and the form and content of interim financial statements in accordance with U.S. GAAP. Per the FASB, the amendment does not intend to change the fundamental nature of interim reporting or expand or reduce current interim disclosure requirements but rather provide clarity and improve navigability of the existing interim reporting requirements. The update will be effective for interim reporting periods within annual reporting periods beginning after December 15, 2027. We are assessing the effect of this update on our consolidated financial statements and related disclosures.

In July 2025, the FASB issued ASU 2025-05, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, which simplifies the application of the current expected credit loss model for current accounts receivable and current contract assets under Accounting Standards Codification 606. The Company adopted ASU 2025-05 effective January 1, 2026. The adoption did not have a material impact on the Company’s consolidated financial statements.

We have evaluated all other issued and unadopted Accounting Standards Updates and believe the adoption of these standards will not have a material impact on our consolidated results of operations, financial position, or cash flows.

Note 3 – Property and Equipment

Property and equipment, net consisted of the following:

	September 30, 2026			December 31, 2025

Medical equipment	$	1,182,622		$	758,527
Office/warehouse equipment		54,567			51,008
Warehouse/production equipment		75,084			75,084
		1,312,273			884,619
Less accumulated depreciation		(607,370	)		(518,304	)
Property and equipment, net	$	704,903		$	366,315

Depreciation expense was $40,612 (of which $34,448 was charged to cost of goods sold) and $23,148 (of which $18,543 was charged to cost of goods sold), respectively, for the three months ended September 30, 2026 and 2025. Depreciation expense was $89,066 (of which $73,012 was charged to cost of goods sold) and $61,551 (of which $48,296 was charged to cost of goods sold), respectively, for the nine months ended September 30, 2026 and 2025. None of our long-lived assets were deemed to be impaired during the nine months ended September 30, 2026 and 2025.

Note 4 – Distribution Agreement with Smith+Nephew

On March 31, 2025, we entered into a Distribution Agreement with Smith & Nephew, Inc. (“Smith+Nephew”), a U.S. subsidiary of Smith & Nephew PLC, a global medical technology company. Under the agreement, we will supply to Smith+Nephew its own private label of our Aurix product. Although Smith+Nephew will be the sole and exclusive distributor in the United States of its own private label Aurix product, we have the right and will continue to market, sell, and distribute our branded Aurix product. During the year ended December 31, 2025, we recognized $225,000 in distribution fee revenue under the agreement.

Under the agreement, Smith+Nephew will purchase private label product from us, from time to time at agreed upon transfer pricing and we will manufacture, package, and ship the product to Smith+Nephew’s customers in accordance with purchase orders and the agreement. Commencing in October 2025 through the remainder of the initial term of the agreement, minimum annual purchase commitments of an average of approximately $500,000 will apply for Smith+Nephew to maintain exclusive distribution rights.

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Effective January 1, 2026, we entered into an amendment to the agreement to add certain expansion kits in connection with the Private Label product for which we received an upfront fee of $50,000. In August 2026, we received a $250,000 reimbursement fee milestone based on the establishment of reimbursement coverage in an additional place of service category. As consideration for entering into the original agreement, we received an upfront fee of $1.5 million, and we are eligible for an additional $500,000 milestone fee based on our establishment and maintenance of reimbursement coverage for an additional wound etiology. Such fees will be refundable to Smith+Nephew on a pro rata basis for the unexpired initial term of the agreement if we do not comply with certain terms and conditions. The original distribution fee, January 2026 fee under the amendment, and reimbursement fee milestone are being recognized on a pro rata basis over the applicable initial term of the agreement, and the unearned distribution fees are treated as deferred revenue. During the three and nine months ending September 30, 2026, we recognized $86,562 and $242,444 of revenue under the amended agreement.

The agreement is for an initial term of five years and is renewable for additional two-year terms subject to earlier termination in accordance with the terms and conditions of the agreement. Although the agreement is exclusive to Smith+Nephew in the United States, we are entitled to maintain our existing distributors and sales agents for the Aurix product. The agreement also contains other standard and negotiated terms and conditions including non-solicitation of each party’s customers based on identified customer lists, and certain liability and indemnity clauses.

Note 5 – Stock Purchase Warrants

The following schedule reflects outstanding stock purchase warrants as of September 30, 2026 and December 31, 2025:

Description	September 30, 2026		December 31, 2025

2022 sales incentive warrants		-		200,000
Stock purchase warrants		361,665		-
Total		361,665		200,000

During the nine months ended September 30, 2026 in connection with the issuance of secured notes payable (See Note 6 – Secured Promissory Notes), we issued a series of warrants to purchase up to 361,665 shares of common stock at an exercise price of $1.50 per share and expiring January 23, 2031. The issued warrants consisted of (i) 148,000 immediately vested commitment, origination and capital warrants issued in January upon the initial closing (the "Original Warrants"), (ii) an additional 120,125 immediately vested commitment, origination, and capital warrants issued in May upon an interim funding (the "Interim Warrants"), (iii) 56,875 unvested origination and capital warrants that will vest in the event of Second Funding (the "Contingent Warrants") (see Note 11 – Subsequent Events for additional information), and (iv) up to 36,665 contingent prepayment fee warrants (the "Prepayment Warrants") that will vest in different amounts only in the event of a voluntary or mandatory prepayment that occurs (a) before December 31, 2026 or (b) on or after December 31, 2026 but before December 31, 2027. The number of Interim Warrants reflects a net reduction of 250 shares to account for a $50,000 decrease in the commitment amount of two of the lenders since the Initial Funding. In addition, upon the Interim Funding, we cancelled, as previously issued to the four Lenders in the Initial Funding, securities representing (i) unvested origination and capital warrants which would vest upon a Second Funding and exercisable for an aggregate of 105,000 shares, and (ii) unvested original prepayment warrants exercisable for an aggregate of up to 29,332 shares. The cancelled warrants were replaced by the Contingent Warrants and the Prepayment Warrants discussed above.

The Original Warrants have a fair value at the date of issuance of $149,635 while the Interim Warrants and Contingent Warrants have fair values of $63,660 and $30,141, respectively, on their May 2026 date of issuance. All fair value calculations are based on a Black-Scholes option pricing model where the inputs to calculation were our underlying stock price, the $1.50 exercise price of the warrants, an expected volatility of 75%, the five-year term of the warrants, and the risk-free interest rate corresponding to the term of 3.74% and 4.15% for the January and May issuances, respectively. The allocation of proceeds from the debt transaction to the warrants upon vesting and based on their fair value resulted in a debt discount which was immediately expensed as interest expense due to our election to carry the debt at fair value.

The 200,000 sales incentive warrants outstanding at December 31, 2025 were legally cancelled upon the January 2026 determination date as the sales milestones were not achieved.

Note 6 – Secured Promissory Notes

As previously disclosed in Note 2 - Liquidity and Summary of Significant Accounting Policies, we received $500,000 in proceeds from the pre-funding of loans on December 31, 2025, an additional $500,000 in funding proceeds upon the initial closing in January 2026, and an additional $675,000 in proceeds upon the closing of an interim funding in May 2026. On January 21, 2026, we entered into a Loan and Security Agreement (the “Loan Agreement”) with four lenders (collectively, the “Initial Lenders”), including an original loan amount of $200,000 from a related party and a director of Nuo. The Loan Agreement provided for loans in an aggregate principal amount of up to $1.6 million with (a) $1.0 million funded as of 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. On May 29, 2026, the Loan Agreement was amended (the “Loan Agreement Amendment”) to add a fifth lender, increase the aggregate principal amount available under the loan to $2.0 million, and establish an interim funding of $675,000 which occurred upon the closing on May 29, 2026 (the “Interim Funding”). The loan amount from the related party increased to $300,000 and has a fair value of $323,000 at September 30, 2026. Management evaluated the amendment and accounted for it as a modification. See Note 11 – Subsequent Events for additional information regarding the closing of the Second Funding which occurred subsequent to September 30, 2026.

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At the closing of the Initial Funding and Interim Funding, we issued Secured Promissory Notes (each, an “Initial Note” or “Interim Note”; together, the “Notes” including the Second Notes issued subsequent to September 30, 2026) to the lenders. The Initial Note initially bore interest at an annual rate of 10%. Concurrently with the Interim Funding, the interest rate on the Initial Notes increased to an annual rate of 12%, the interest rate at issuance of the Interim Notes was also 12%, and the interest rate of the Second Notes will also be 12%.

The maturity date of the Notes is December 31, 2028 (the “Maturity Date”).

In connection with the issuance of the secured notes payable at the Initial and Interim Fundings, we issued up to 361,665 warrants to purchase common shares of common stock at an exercise price of $1.50 per common share. (See Note 5 – Stock Purchase Warrants for further information). The 148,000 vested warrants issued at the Initial Funding had a fair value of $149,635 and the additional 120,125 vested warrants issued at the Interim Funding had a fair value of $63,660. Upon their vesting, all warrant issuances created a debt discount that was amortized immediately as additional interest expense.

Interest on 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.

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.

In addition, the Loan Agreement, as amended and restated, mandates the prepayment of the Notes in the event of (i) an equity financing of at least $5 million, (ii) certain changes in control as defined in the Loan Agreement, or (iii) 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.

The Notes are secured by a lien upon and security interest in all of the Company’s assets, including intellectual property. The Loan Agreement, as amended and restated, contains customary representations, warranties, and covenants.

We elected to account for the secured notes payable using the fair value option. See Note 8 - Fair Value for further information.

Note 7 – Equity and Stock-Based Compensation

Under the Second Amended and Restated Certificate of Incorporation, we have the authority to issue a total of 101,000,000 shares of capital stock, consisting of 100,000,000 shares of common stock and 1,000,000 shares of preferred stock, par value $0.0001 per share, which will have such rights, powers and preferences as the Board of Directors shall determine.

Issuance of Common Stock for Vendor Services Rendered

During the nine months ended September 30, 2026, we issued 50,861 shares of common stock in exchange for services rendered from a vendor totaling $61,500.

Stock-Based Compensation

In July 2016, the Board of Directors approved the 2016 Omnibus Incentive Plan (the “Plan”), and in November 2016, holders of a majority of our capital stock approved the Plan, as amended and restated, which provides for the grant of equity and cash incentive awards to officers, directors and employees of, and consultants to, Nuo Therapeutics and its subsidiaries. Further, in March 2022, the Board approved an amendment to the Plan to increase the shares available to 4,250,000 and remove an annual evergreen provision, which was approved by the holders of a majority of our outstanding common stock and which became effective in June 2022. The Plan provided for a duration of ten years and, accordingly, our ability to issue new stock options and other awards under the Plan ended on July 1, 2026.

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A summary of stock option activity under the Plan during the nine months ended September 30, 2026 is presented below:

Stock Options – 2016 Omnibus Plan	Shares			Weighted Average Exercise Price		Weighted Average Remaining Contractual Term

Outstanding at January 1, 2026		2,380,582		$	0.73		5.84
Granted		1,125,000			1.13		10.0
Exercised		(816,875	)		0.68		-
Forfeited or expired		(200,625	)		1.13		-
Outstanding at September 30, 2026		2,488,082		$	0.89		7.59
Exercisable at September 30, 2026		1,308,915		$	0.69		5.80

During the nine months ended September 30, 2026, 1,125,000 stock options were granted to senior management, members of the board of directors, and employees of which (i) 90,000 were granted to independent members of the board of directors with vesting occurring on the one-year anniversary of the grant, (ii) 760,000 were granted pursuant to a three-year vesting schedule, and (iii) 275,000 options contained vesting provisions through December 31, 2028 pursuant to the achievement of either certain commercial sales targets for the years ended December 31, 2026 and 2027 or certain reimbursement coverage milestones. The fair value of the employee options vesting over the three-year vesting schedule was approximately $430,000 while the performance-based options had a fair value of approximately $222,700. Fair value of the options granted to senior management and members of the board of directors was $188,000.

During the nine months ended September 30, 2026, 816,875 options were exercised on a cashless basis resulting in the issuance of 343,994 shares of common stock. The aggregate intrinsic value for outstanding and exercisable options as of September 30, 2026 was approximately $855,000 and $734,000, respectively. During the nine months ended September 30, 2025, 176,000 stock options were granted to employees and a third-party consultant. The fair value of the options to vest over three years was approximately $105,900.

For the three months ended September 30, 2026 and 2025, we recorded stock-based compensation expense of $89,238 and $19,915, respectively. For the nine months ended September 30, 2026 and 2025, we recorded stock-based compensation expense of $154,255 and $62,459, respectively. As of September 30, 2026, there was approximately $787,000 unrecognized compensation cost related to the non-vested stock options of which $581,000 is expected to be recognized prior to year-end 2029 over a weighted average period of 2.5 years while the recognition of approximately $206,000 is subject to the achievement of the performance-based vesting provisions.

Note 8 – Fair Value

Our consolidated balance sheets include various financial instruments (primarily cash, accounts receivable and accounts payable and accrued expenses) that are carried at cost, which approximates fair value due to the short-term nature of the instruments.

Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

We elected to account for the secured notes payable under the fair value option. The fair value of the secured notes payable is calculated using unobservable Level 3 inputs. At the date of issuance and September 30, 2026, the fair value of the secured notes is deemed to be equivalent to the face value of the loan plus accrued interest as the terms of the loan including maturity and interest rate are considered market based. We have no other financial assets or liabilities measured at fair value on a recurring basis.

Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis

We had no financial assets or liabilities measured at fair value on a non-recurring basis as of September 30, 2026 or December 31, 2025.

Non-Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis

We had no non-financial assets or liabilities measured at fair value on a recurring basis as of September 30, 2026 or December 31, 2025.

Non-Financial Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis

We measure our long-lived assets, including property and equipment and operating lease right of use assets, at fair value on a non-recurring basis. These assets are recognized at fair value when they are deemed to be impaired. No impairment was recognized during the nine months ended September 30, 2026 or 2025.

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The following table presents our liabilities measured at fair value as of September 30, 2026:

	Quoted Prices in Active Markets for Identical Assets (Level 1)		Significant Other Observable Inputs (Level 2)		Significant Unobservable Inputs (Level 3)

Notes payable	$	-	$	-	$	1,477,500
Notes payable – related party		-		-		323,000
Total liabilities	$	-	$	-	$	1,800,500

The following table presents changes in the fair value of our Level 3 liabilities for the nine months ending September 30, 2026:

	Notes Payable		Notes Payable – Related Party		Total Notes Payable

Balance at December 31, 2025	$	300,000	$	200,000	$	500,000
Notes payable at issuance		1,075,000		100,000		1,175,000
Change in fair value		102,500		23,000		125,500
Balance at September 30, 2026	$	1,477,500	$	323,000	$	1,800,500

Note 9 – Segment Information

We manage our business activities on a consolidated basis and operate as a single operating segment dedicated to developing and marketing products for chronic wound care that harness the regenerative capacity of the human body to trigger natural healing. We derive our revenue from sales of the Aurix and Private Label branded product lines and distribution fee revenue from Smith+Nephew. The accounting policies of the segment are the same as those described in Note 2 – Liquidity and Summary of Significant Accounting Policies.

Our CODM is Nuo’s Chief Executive and Financial Officer, David E. Jorden. The CODM uses net loss, as reported in our consolidated statements of operations, in evaluating the performance of the segment and determining how to allocate our resources as a whole. The CODM does not review assets in evaluating the results of the segment, and therefore, such information is not presented.

The following table presents the operating results of the segment:

	Three Months Ended September 30,			Three Months Ended September 30,			Nine Months Ended September 30,			Nine Months Ended September 30,
	2026			2025			2026			2025
Total revenues	$	1,866,125		$	1,032,096		$	4,937,226		$	2,216,679
Less significant segment expenses:
Aurix cost of sales (excluding provision for inventory obsolescence and applicable depreciation expense)		316,731			137,911			891,239			379,410
Private label cost of sales		322,155			250,267			760,430			250,267
Total compensation and benefit costs (including third party commission expense)		874,325			674,499			2,528,468			1,883,308
Provisions for credit losses and inventory obsolescence		73,960			28,876			73,960			50,520
All other operating expenses (excluding depreciation and credit loss provision)^(a)		503,655			419,549			1,369,033			1,413,497
Other segment items:
Depreciation, amortization of right of use assets, and stock-based compensation		149,731			61,136			301,546			176,988
Interest expense (income), net		51,099			(409	)		340,447			33
Other expense (income), net		(603	)		(1,814	)		(6,902	)		(3,608	)
Consolidated net loss	$	(424,928	)	$	(537,919	)	$	(1,320,995	)	$	(1,933,736	)

(a)

All other operating expenses included in consolidated net loss includes professional fees, lease expenses, insurance costs, travel and entertainment expenses, and all other selling, general and administrative expenses.

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Note 10 – Commitments and Contingencies

From time to time, the Company may be involved in various legal proceedings, claims, and investigations arising in the ordinary course of business. The Company records a liability when it is probable that a loss has been incurred and the amount can be reasonably estimated. While the outcome of such matters cannot be predicted with certainty, management believes that the ultimate resolution of these matters will not have a material adverse effect on the Company’s financial position, results of operations, or cash flows.

In February 2022, we entered into a commercial operating lease for our primary office and warehouse/distribution space in Texas. The lease requires us to pay for insurance, taxes, and our share of common operating expenses. This lease expires in March 2027. This lease is classified as an operating lease and we established a right of use asset and lease liability using a 10% discount rate.

Total operating lease costs were approximately $29,000 and $28,600 for the three months ended September 30, 2026 and 2025, respectively, and approximately $87,900 and $86,100 for the nine months ended September 30, 2026 and 2025, respectively. Operating lease costs consist solely of base rental and common area maintenance costs. We have no financing leases.

Future undiscounted cash flows under this lease are:

2026	$	20,677
2027		21,284
Total operating lease payments		41,961

Discount factor		(1,205	)
Present value of operating lease liabilities		40,756
Current portion of operating lease liabilities		(40,756	)
Non-current portion of operating lease liabilities	$	-

Note 11 – Subsequent Events

Issuance of Common Stock for Vendor Services Rendered

Subsequent to September 30, 2026, we issued 11,699 shares of common stock in exchange for services rendered from a vendor totaling $15,000.

On October 6, 2026, we entered into an Assignment, Joinder, and Amendment No. 1 (the “Amendment”) to the Amended and Restated Loan and Security Agreement and closed on the Second Funding receiving $325,000 in additional loan proceeds from the lenders. The Amendment changed the closing date of the Second Funding to October 6, 2026 from September 30, 2026. The Amendment also enabled a lender to assign a $100,000 portion of the lender’s Second Funding commitment and to enable three new persons to join the Loan Agreement as lenders. The loan amount from the related party increased by $25,000. Accordingly, the related party loaned $125,000 in the Second Funding representing an aggregate funding of $425,000 by the related party. In connection with the Second Funding, we issued Second Notes to the lenders, including the related party, bearing interest at 12% per annum with a maturity date of December 31, 2028. We also elected the fair value option upon the vesting of the previously issued 56,875 unvested warrants which vested upon the Second Funding (see Note 5 - Stock Purchase Warrants for additional information). The resulting $30,141 fair value of the warrants was treated as a debt discount which was immediately expensed as interest expense due to our election to carry the debt at fair value.

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ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of the financial condition and results of operations of Nuo Therapeutics, Inc. ("Nuo," the "Company," "we," "us," or "our") should be read in conjunction with the financial statements and related notes appearing elsewhere in this Quarterly Report and our Annual Report on Form 10-K for the year ended December 31, 2025 (our “Annual Report”), filed with the U.S. Securities and Exchange Commission (the "SEC") on March 30, 2026.

The Company owns or has rights to various copyrights, trademarks and trade names used in its business, including, but not limited to, Aurix®. This Quarterly Report also includes discussions of or references to other trademarks, service marks, and trade names of other companies, including, but not limited to, the Angel Whole Blood Separation System®. Other trademarks and trade names appearing in this Quarterly Report are the property of the holder of such trademarks and trade names.

Special Note Regarding Forward Looking Statements

Certain statements, other than purely historical information in this Quarterly Report (including this section) 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 Quarterly Report and in other reports filed by us with the SEC, including Forms 8-K, 10-Q, and 10-K. 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 ability to protect our intellectual property;
	●	our compliance with governmental regulations;
	●	our reliance on several single source suppliers and our ability to source raw materials at affordable costs;
	●	a future or continuing interruption in the supply of any reagent component of the Aurix System;
	●	our ability to successfully sell and market the Aurix System;
	●	our ability to perform under and realize sales and related benefits from our distribution agreement with Smith+Nephew as well as its ability to market and sell its private label Aurix product;
	●	the fees, minimum purchase commitments, and expenses and costs associated with our distribution agreement with Smith+Nephew; and
	●	our ability to successfully pursue strategic collaborations to help develop, support, or commercialize our current and future products.

Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could differ materially from those anticipated in these forward-looking statements.

In addition to the risks identified under the heading “Risk Factors” in our Annual Report and the other filings referenced above, other sections of this Quarterly Report may include additional factors which could adversely affect our business and financial performance. Moreover, we operate in a very competitive and rapidly changing environment. New risk factors emerge from time to time, and it is not possible for management to predict all such risk factors, nor can it assess the impact of all such risk factors on our business, or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, investors should not place undue reliance on forward-looking statements as a prediction of actual results.

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The Company undertakes no obligation and does not intend to update, revise or otherwise publicly release any revisions to its forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of any unanticipated events.

Our Business and Product

We are a commercial-stage medical device 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) 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.

Our only significant current commercial offering consists of a point of care technology for the separation of autologous blood to produce a platelet-based therapy for use in the chronic wound care market. This offering is known as “Aurix” or the “Aurix System”. The 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 three platelet derived products cleared by the FDA for chronic wound care use and can be used 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, and was estimated to be an approximately $10.8 billion global market in 2021 with the North American market estimated at approximately $4.15 billion in 2020. Estimates remain that 1-2% of the population in the developed countries will suffer from a chronic wound at least once in their lifetime. According to the National Institute of Health, treatment of diabetic foot ulcers cost an estimated $9-$13 billion annually in the U.S. alone. An aging population and the still increasing prevalence of diabetes suggests a continued increase in the patient population at risk of developing chronic, non-healing wounds.

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. The Aurix PRP comprises a natural, endogenous complement of protein and non-protein signal molecules that are believed to 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 is thought to work by restoring 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 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 selected for a variety of other therapies, including transcatheter aortic valve repair and cochlear implantation. Under a 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. Due to 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.

In May 2019, we transmitted a letter memorandum to CMS’ Coverage and Analysis Group (“CAG”) in support of our completed formal request for reconsideration of the then existing national coverage determination based on the clinical data collected and published under the CED program. The completed formal public request for reconsideration was made on May 8, 2019.

In April 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 individual patients' care 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 is determined by local Medicare Administrative Contractors ("MACs").

Although the FDA cleared the Aurix System for marketing for wound care management in 2007 under Section 510(k) of the FDCA, economically viable reimbursement in the commercial market for the product only became viable with CMS's issuance of the NCD in 2021. For 2026, the CMS national average reimbursement rate for the Aurix System is $2,108 per treatment in place of service ("POS") 22 (hospital outpatient departments), which we believe provides appropriate payment to facilities for product usage. For 2027, the proposed payment in POS 22 is $2,360 pursuant to the proposed Outpatient Prospective Payment System (“OPPS”) covering Medicare payments in hospitals and ambulatory surgery centers.

In 2023 and 2024, we submitted public comments to CMS as part of its annual rule-making procedures under the Physician Fee Schedule ("PFS") for payments to clinicians in primarily POS 11 (physician offices) in both 2023 and 2024. In November 2024, CMS issued its final PFS for calendar 2025 and established a national average payment of $890. In response to this final rule which removed the payment amount discretion from the MACs within POS 11, the Aurix System became economically viable within the physician office care setting effective January 1, 2025. For 2026, the CMS national average reimbursement rate for the Aurix System is $1,064 per treatment in POS 11 (private offices).

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Our Strategy and Market

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 throughout the United States and internationally. Our commercial team consists of three senior employees who are leveraging their current and historical relationships to establish additional third-party sales arrangements.

Following the restart of our business activities in October 2021, commercially available Aurix product first became available in May 2022 for demonstration and evaluation purposes. While limited initial commercial revenues were recorded during the second half of 2022, product adoption has consistently increased with product revenues of approximately $1.4 million in 2024 increasing to approximately $3.1 million in 2025, and we expect revenues will continue growing in the future.

As of September 30, 2026, we had established contractual relationships with more than 200 third-party entities and individual representatives. The number of sales agent representatives may continue to expand modestly in the months ahead, but the current focus is broadening commercial customer relationships with wound care providers operating in private office settings while continuing to engage with hospitals and hospital systems regarding expanded POS 22 usage while ensuring that the reimbursement mechanisms are appropriately administered by the local Medicare Administrative Contractors in support of the April 2021 NCD.

Distribution Agreement with Smith+Nephew

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 supply to Smith+Nephew 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.

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 commercial sales 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.

As consideration for entering into the Distribution Agreement, Smith+Nephew paid us an upfront distribution fee of $1,500,000 for distribution rights. Smith+Nephew also agreed to pay us additional fees as described below.

In August 2026, we received a $250,000 milestone payment based on the establishment of reimbursement coverage in an additional place of service category and we continue to be eligible for an additional $500,000 in milestone payments if we establish and maintain reimbursement coverage for an additional wound etiology.

In January 2026, Smith+Nephew further paid us an upfront fee of $50,000, pursuant to a Distribution Agreement amendment to add certain expansion kits in connection with the Private Label product.

The distribution fee and other fees described above 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.

The Distribution Agreement is for an initial term of five years and is renewable for additional two-year terms subject to earlier termination in accordance with the terms and conditions of the agreement. Although the Distribution Agreement is exclusive to Smith+Nephew in the United States, we are entitled to maintain our existing distributors and increase our sales agent network for the Aurix product. The Distribution Agreement also contains other standard and negotiated terms and conditions including non-solicitation of each party’s customers based on identified customer lists, and liability and indemnity clauses.

Supply and Manufacturing

We outsource the manufacturing of various Aurix 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 components needed to satisfy customer demand.

While most components of Aurix are generally readily available on the open market, our sole supplier of the bovine thrombin reagent used in Aurix - Thrombin-JMI (“TJMI”) - has been Pfizer, with which we have a long-standing supply agreement that has no obligation to supply TJMI. Historically, we have used single suppliers for several components of the Aurix product line; however, when feasible, we obtain alternative suppliers of components, such as in 2025 when we established a dual supply for an ascorbic acid reagent component of Aurix.

In the second quarter of 2026, we became aware that Pfizer was experiencing challenges regarding regular uninterrupted supply of commercially available TJMI. We use only the lyophilized thrombin vial (not the diluent vial) as a component in the Aurix reagent kit. Nonetheless, by the third quarter of 2026, TJMI was on back order with resupply currently estimated for the second quarter of 2027.

Due to the TJMI supply interruption, the Aurix product entered a temporary out-of-stock situation for approximately two weeks in early August 2026.

While we have mitigated Aurix's TJMI supply interruption with an alternative supply of bovine thrombin for at least the short term, we are continuing to pursue longer-term alternative approaches, supplies, and suppliers of thrombin to use in the Aurix product line. These alternatives include seeking FDA regulatory relief, utilizing human recombinant thrombin, and establishing sources of supply from outside the United States. Despite our efforts, we may be unable to obtain, utilize, or establish these alternatives in the long term, or at all, at prices or quality levels that are acceptable to us or that meet applicable regulatory clearance or approval requirements, including import and customs requirements.

There can be no assurance as to when or whether the supply of TJMI will resume, in its original or different packaging configurations, or whether the supply of TJMI will resume at preexisting levels. Further, Pfizer may unilaterally raise the price or alter its allocation of TJMI to us or may decline to renew or may terminate our supply agreement.

If our alternative supply of bovine thrombin or our other alternative approaches are insufficient, untimely, or do not meet applicable standards, our ability to supply Aurix would be disrupted and our Aurix commercialization efforts and operating results would be adversely affected.

If a temporary or permanent interruption in the supply of any reagent occurs, or if the manufacturing costs charged by any supplier exceed what we can reasonably afford, we would need to seek alternative sources of supply. There is no assurance we would be able to identify a suitable alternative source of supply or would be able to do so without significant delay. Despite our efforts to maintain an adequate supply of inventory, the loss of a supplier or its inability to provide us with an adequate supply of a reagent could cause delay in manufacture of our product, impair our ability to meet customer demand, or increase our expenses, harm our commercialization efforts, and adversely affect our operating results.

The Science Underlying Aurix/Platelet Rich Plasma

Normal Wound Healing

The science underlying wound healing is well-established. An immediate early event critical for wound healing is the influx of platelets to the wound site. Platelets bind to elements within damaged tissue such as collagen fragments and endogenous thrombin molecules and are activated to release a diversity of growth factors and other biomolecules from their alpha and dense granules (Reed 2000, Nieswandt, 2003). These biomolecules provide signals essential for biological responses regulating hemostasis and effective tissue regeneration.

Chronic Wounds

Dysregulation of numerous cellular and biological responses contribute to the chronic wound phenotype. Chronic wounds have reduced levels of growth factors and concomitant decreases in cellular proliferation (Mast 1996). There is increased cellular senescence (Telgenhoff 2005), and there generally is a lack of perfusion that can inhibit the delivery of nutrients and cells required for regeneration (Guo 2010). As the body attempts to stave off infection, elevated concentrations of free radicals accumulate in the chronic wound and further damage surrounding tissue (Moseley 2004, James 2003).

Aurix Therapy

Aurix has been cleared by FDA for marketing with an indication for wound management including such chronic wounds as leg ulcers, pressure ulcers, and diabetic ulcers and other exuding wounds such as mechanically or surgically debrided wounds. The Aurix therapeutic is formed by mixing a sample of a patient’s platelets and plasma with pharmaceutical grade thrombin and ascorbic acid. The thrombin activates platelets while ascorbic acid drives the synthesis of high tensile strength collagen, clears damaging free radicals and controls gel consistency. The topical dermal application of Aurix gel bypasses the lack of local perfusion to provide immediate signals for new tissue formation and ultimately healing.

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The Efficacy of Aurix Relates to Biological Activity Released by Platelets

Regenerative Capacity

More than 300 proteins are released by human platelets in response to thrombin activation (Coppinger 2004). Important examples include vascular endothelial cell growth factor (“VEGF”), platelet derived growth factor (“PDGF”), epidermal growth factor (“EGF”), fibroblast growth factor (“FGF”) and transforming growth factor-beta (“TGF-B”) (Eppley 2004, Everts 2006). These proteins are critical for organized wound healing, regulating responses such as vascularization, cell proliferation, cell differentiation, and deposition of new extracellular matrix (Goldman 2004). Platelets also release chemokines such as Interleukin-8 (“IL-8”), stromal cell derived factor-1 (“SDF-1”), and platelet factor-4 (“PF-4”) (Chatterjee 2011, Gear 2003) that control the mobilization and migration of stem cells and fibroblasts (Werner 2003 and Gillitzer 2001), which contribute to tissue regeneration.

Anti-infective Activity

The bioburden population in chronic wounds vary over time and wounds invariably retain or become re-infected with some level of bacteria that is detrimental to healing (Howell-Jones 2005). In addition to regenerative capacity, platelets release anti-microbial peptides effective against a broad range of pathogens including Methicillin Resistant Staphylococcus Aureus (“MRSA”) (Moojen 2007, Jia 2010, Tang 2002, Bielecki 2007).

Clinical Efficacy

Multiple efficacy and effectiveness studies have been published in peer reviewed journals documenting the impact of using Aurix to treat chronic wounds, available as part of the reconsideration review by CMS in establishing the NCD, including the following:

	●	In the published study of the clinical data collected during the CED program for diabetic foot ulcers, Aurix demonstrated a significant time to heal advantage compared to wounds treated with usual and customary care (including any available advanced therapy). A higher percentage of healing was observed across all wound severities (Wagner Grade 1-4) and in a patient population with significant comorbidities. (Gude W, Hagan D, Abood F, Clausen P: Aurix Gel is an Effective Intervention for Chronic Diabetic Foot Ulcers: A Pragmatic Randomized Controlled Trial. Advances in Skin and Wound Care, 2019; 32(9): 416-426.)

	●	In a double blinded randomized controlled trial, 81% of the most common-sized diabetic foot ulcers healed with Aurix compared with 42% of control wounds. Mean time to healing was six weeks. (Driver V, Hanft J, Fylling, C et al.: A Prospective, Randomized, Controlled Trial of Autologous Platelet-Rich Plasma Gel for the Treatment of Diabetic Foot Ulcers. Ostomy Wound Management, 2006; 52(6): 68-87.)

	●	In 285 chronic wounds in 200 patients, 96.5% of the wounds had a positive response within an average of 2.2 weeks with an average of 2.8 Aurix treatments (de Leon J, Driver VR, Fylling CP, Carter MJ, Anderson C, Wilson J, et al.: The Clinical Relevance of Treating Chronic Wounds with an Enhanced Near-physiological Concentration of Platelet-Rich Plasma (PRP) Gel. Advances in Skin and Wound Care, 2011; 24(8), 357-368.)

	●	In a retrospective, longitudinal study of 40 Wagner grade II through IV diabetic foot ulcers, most with critical limb ischemia, wounds increased in size in the approximately 100 days prior to the initiation of comprehensive wound care treatment. Upon treatment with debridement, revascularization, antibiotics and off-loading, the wounds continued to increase in size over a subsequent 75-day period. Once they were then treated with Aurix, the wounds immediately changed healing trajectory and 83% of the wounds healed with an average of 6.1 Aurix treatments per wound (Sakata, J., Sasaki, S., Handa, K., et al. A Retrospective, Longitudinal Study to Evaluate Healing Lower Extremity Wounds in Patients with Diabetes Mellitus and Ischemia Using Standard Protocols of Care and Platelet-Rich Plasma Gel in a Japanese Wound Care Program. Ostomy Wound Management, 2012; 58(4):36-49.)

Results of Operations

The amounts presented in these comparison sections are rounded to the nearest thousand.

Comparison of Three Months Ended September 30, 2026 and 2025

Revenue and Gross Profit

Total revenues for the three months ended September 30, 2026 totaled approximately $1,866,000 including approximately $87,000 of distribution fee revenue related to the Smith+Nephew distribution agreement as amended. Product revenues for the three months ended September 30, 2026 totaled approximately $1,780,000 in comparison to product only revenues of approximately $957,000 for the three months ended September 30, 2025 representing an increase of approximately $823,000 or approximately 86%. Product revenues associated with the Smith+Nephew private label distribution arrangement recognized during the three months ended September 30, 2025 consisted solely of centrifuge devices sold to Smith+Nephew. Associated gross profit was approximately $1,193,000 for the three months ended September 30, 2026 in comparison to approximately $625,000 of gross profit in the three months ended September 30, 2025 and increased approximately 91%.

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The increase in revenues was due primarily to (i) increased Aurix product revenues resulting from an expanding customer base over the past year and (ii) Smith+Nephew related product revenues for centrifuge devices and kits. Aggregate gross margin was approximately 64% for the three months ended September 30, 2026 as compared to approximately 61% for the three months ended September 30, 2025. The gross margin increase was primarily due to all Smith+Nephew product sales in the prior year period consisting of centrifuge devices sold to Smith+Nephew at a near zero gross margin on the transfer price of the devices.

Operating Expenses

Total operating expenses increased approximately $402,000 to approximately $1,567,000 comparing the three months ended September 30, 2026 to the three months ended September 30, 2025. The increase from the prior year was due primarily to increases in (i) compensation and benefit costs of approximately $71,000, (ii) third party commission expense of approximately $128,000 for independent sales representatives and distributors resulting from increased Aurix product revenues, (iii) approximately $63,000 in professional fees primarily resulting from regulatory consulting expenses associated with the reagent supply chain matters, (iv) non-cash stock based compensation expense of approximately $69,000, and (v) provision for credit losses of approximately $45,000.

Other Income (Expense)

Interest income (expense), net for the three months ended September 30, 2026 primarily represents $50,250 of non-cash interest expense on the secured notes payable while other income (expense) for the three months ended September 30, 2025 was nominal.

Comparison of Nine Months Ended September 30, 2026 and 2025

Revenue and Gross Profit

Total revenues for the nine months ended September 30, 2026 totaled approximately $4,937,000 including approximately $242,000 of distribution fee revenue related to the Smith+Nephew distribution agreement as amended. Product revenues for the nine months ended September 30, 2026 totaled approximately $4,695,000 in comparison to product revenues of approximately $2,067,000 for the nine months ended September 30, 2025 representing an increase of approximately $2,628,000 or approximately 127%. Product revenues associated with the Smith+Nephew private label distribution arrangement recognized during the nine months ended September 30, 2025 consisted solely of centrifuge devices sold to Smith+Nephew . Associated gross profit was approximately $3,213,000 for the nine months ended September 30, 2026 in comparison to approximately $1,530,000 of gross profit in the nine months ended September 30, 2025 and increased approximately 110%.

The increase in revenues was due primarily to (i) increased Aurix product revenues resulting from an expanding customer base over the past year, (ii) Smith+Nephew related product revenues for centrifuge devices and kits and (iii) distribution fee revenue recognized under the distribution agreement as amended. Aggregate gross margin was approximately 65% for the nine months ended September 30, 2026 as compared to approximately 69% for the nine months ended September 30, 2025. The gross margin decline was primarily due to (i) the centrifuge devices sold to Smith+Nephew at a near zero gross margin on the transfer price of the devices and (ii) lower product gross margins on sales of Private Label kits to Smith+Nephew resulting from transfer pricing.

Operating Expenses

Total operating expenses increased approximately $733,000 to approximately $4,200,000 comparing the nine months ended September 30, 2026 to the nine months ended September 30, 2025. The increase from the prior year was due primarily to increases in (i) compensation and benefit costs of approximately $271,000, (ii) third party commission expense of approximately $374,000 for independent sales representatives and distributors resulting from increased Aurix product revenues, and (iii) stock based compensation expense of approximately $92,000.

Other Income (Expense)

Interest income (expense), net for the nine months ended September 30, 2026 primarily represents (i) $125,500 of non-cash interest expense on the secured notes payable and (ii) $213,295 of debt discount amortization considered interest expense due to our election of the fair value option on all of the fundings of secured notes payable while other income (expense) for the nine months ended September 30, 2025 was nominal.

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Liquidity and Capital Resources

Overview

As of September 30, 2026, we had cash balances of approximately $0.1 million, total current assets of approximately $2.0 million and total current liabilities of approximately $2.5 million. As an operational business, 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 September 30, 2026, our accumulated deficit was approximately $36.1 million and our stockholders’ deficit was approximately $1.8 million.

In January 2026, we received funding proceeds from the issuance of secured notes payable of $500,000 in addition to $500,000 of proceeds which were pre-funded on December 31, 2025. The total amount of notes payable at the initial closing was $1,000,000. In May 2026, we received additional proceeds of $675,000 from the issuance of secured notes payable in an interim funding.

Our continuing losses and limited cash resources raise substantial doubt about our ability to continue as a going concern, and we need to raise additional funds in order to continue to conduct our business. If we are unable to secure sufficient capital to fund our operating activities, we may be forced to delay further the completion of, or significantly reduce the scope of, our current business plan. It is uncertain whether we will be able to obtain such financing on satisfactory terms or at all. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

We may not be able to obtain additional capital as required to finance our efforts, through equity or debt financing or any combination thereof, on satisfactory terms or at all. Additionally, any such financing, if obtained, may not be adequate to meet our capital needs and to support our operations. As such, we believe that substantial doubt about our ability to continue as a going concern exists.

We maintain our cash deposits primarily in financial institutions, which may at times exceed amounts covered by insurance provided by the U.S. Federal Deposit Insurance Corporation (“FDIC”). We have not experienced any losses related to amounts in excess of FDIC limits.

Cash Flows

Net cash provided by (used in) operating, investing, and financing activities for the periods presented were as follows:

	Nine Months Ended September 30, 2026			Nine Months Ended September 30, 2025
Cash flows used in operating activities	$	(1,215,351	)	$	(442,325	)
Cash flows used in investing activities	$	(427,654	)	$	(231,551	)
Cash flow provided by financing activities	$	1,175,000		$	904,959

Operating Activities

Cash used in operating activities for the nine months ended September 30, 2026 of approximately $1,215,000 primarily reflects our net loss of approximately $1,321,000 adjusted by (i) approximately $670,000 net change in operating assets and liabilities and partially offset by (ii) non-cash interest expense and amortization of debt discount on notes payable issued of approximately $339,000, and (iii) approximately $437,000 in total for amortization of right of use assets, depreciation of property and equipment, stock-based compensation, provision for credit losses, and vendor expense settled in shares of common stock.

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.

Investing Activities

Cash used in investing activities for the nine months ended September 30, 2026 and 2025 primarily represents approximately $428,000 and $220,000, respectively in capital expenditures for the purchase of centrifuge devices.

Financing Activities

For the nine months ended September 30, 2026, we received an additional $500,000 in loan proceeds under the secured notes payable after $500,000 of proceeds were pre-funded on December 31, 2025 and a further $675,000 in loan proceeds from an interim funding in May 2026.

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.

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Amended and Restated Loan and Security Agreement, as Amended

Loan Agreement

On January 21, 2026, the Company entered into a Loan and Security Agreement (the “Initial Loan Agreement”) with four lenders, including Scott Pittman, a director of the Company. On May 29, 2026, the Company entered into an Amended and Restated Loan and Security Agreement (the “Interim Loan Agreement”) to amend and restate the Initial Loan Agreement and add one additional lender.

The Initial Loan Agreement provided for an aggregate commitment of $1.6 million of the lenders that included $1,000,000 on the January 23, 2026 initial closing date (the “Initial Funding”). The Interim Loan Agreement provided for a $400,000 increase in the aggregate commitment of the lenders and an adjustment of their loan amounts such that their funding commitment totaled an aggregate principal amount of up to $2.0 million based upon (a) $1,000,000 previously funded in the Initial Funding, (b) $675,000 funded on the interim closing date (the “Interim Funding”), and (c) $325,000 to be funded, if requested by the Company and subject to closing conditions, on September 30, 2026 (the “Second Funding”). The closing of the Interim Funding occurred on May 29, 2026.

On October 6, 2026, the Company entered into an Assignment, Joinder, and Amendment No. 1 (the “Amendment”) to the Interim Loan Agreement (as amended, the “Loan Agreement”) to change the closing date of the Second Funding to October 6, 2026. The Amendment also enabled a lender to assign a $100,000 portion of the lender’s Second Funding commitment and enabled three new persons to join the Loan Agreement as lenders (collectively, the “Lenders”). The closing of the Second Funding occurred on October 6, 2026 as provided for in the Amendment and the Company received the full Second Funding amount of $325,000.

The Company therefore has received an aggregate of $2,000,000 from Lenders in accordance with the Loan Agreement and consistent with the $2.0 million total funding commitment.

At the closing of the Initial Funding, the Company issued Secured Promissory Notes (each, an “Initial Note”) bearing interest at an annual rate of 10% to the Lenders. At the closing of the Interim Funding, the Company issued Secured Promissory Notes (each, an “Interim Note”) to the Lenders. At the closing of the Second Funding, the Company issued additional Secured Promissory Notes (each, a “Second Note”) to the Lenders. The Interim Notes and the Second Notes bear interest at an annual rate of 12%. In addition, pursuant to the Interim Loan Agreement, the interest rate of Initial Notes previously issued pursuant to the Initial Loan Agreement increased from 10% to an annual rate of 12% upon the Interim Funding.

The maturity date of the Initial Notes, the Interim Notes, and the Second Notes (together, the “Notes”) is December 31, 2028 (the “Maturity Date”).

Interest on the Notes will be payable in Interest Warrants as described below, and not in cash. Interest on the Notes will be payable and issued at the Maturity Date (or earlier upon certain prepayments as described below). 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.

The Company may, at its 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 Restated Warrants as described below, and not in cash, that will vest in the event of a voluntary prepayment.

In addition, the Loan Agreement mandates the prepayment of the Notes in the event of (i) an equity financing of at least $5 million, (ii) certain changes in control as defined in the Loan Agreement, or (iii) a default by the Company. In the event of such an equity financing or change in control, the Company has 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, the Company has 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 Prepayment Restated Warrants as described below, and not in cash, that will vest in the event of a mandatory prepayment.

The Notes are secured by a lien upon and security interest in all of the Company’s assets, including intellectual property.

Warrants

On January 23, 2026, the closing date of the Initial Funding, and pursuant to the Initial Loan Agreement, the Company (a) issued warrants, a portion of which are subject to vesting provisions, to the Lenders in the Initial Funding to purchase shares of the Company’s common stock, and (b) agreed to issue additional warrants to the Lenders in the Interim Funding to purchase shares of the Company’s common stock as payment for accrued interest under the Notes.

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On May 29, 2026, the closing date of the Interim Funding, and pursuant to the Interim Loan Agreement, the Company (a) issued warrants, a portion of which are subject to vesting provisions, to the Lenders in the Interim Funding to purchase shares of the Company’s common stock, (b) cancelled certain warrants previously issued pursuant to the Initial Funding, and (c) again agreed to issue additional warrants to the Lenders in the Interim Funding to purchase shares of the Company’s common stock as payment for accrued interest under the Notes.

On October 6, 2026, the closing date of the Second Funding, and pursuant to the Loan Agreement, the Company (a) issued warrants, a portion of which are subject to vesting provisions, to the Lenders in the Second Funding to purchase shares of the Company’s common stock, (b) cancelled certain warrants previously issued pursuant to the Initial Funding and Interim Funding, and (c) again agreed to issue additional warrants to the Lenders in the Second Funding to purchase shares of the Company’s common stock as payment for accrued interest under the Notes.

The securities issued by the Company at the closing of the Initial Funding consisted of: (i) warrants representing a fee of 0.75% of each Lender’s commitment pursuant to the Loan Agreement (the “Commitment Warrants”); (ii) warrants representing a fee of 1.0% of each Lender’s loan amount in the Initial Funding (the “Origination Initial Warrants”); (iii) warrants representing 20% coverage of each Lender’s loan amount in the Initial Funding (the “Capital Initial Warrants”); (iv) warrants representing a fee of 1.25% of each Lender’s loan commitment amount in the Second Funding, vesting only upon the occurrence of the Second Funding (the “Origination Second Warrants”); (v) warrants representing 25% coverage of each Lender’s loan commitment amount in the Second Funding, vesting only upon the occurrence of a Second Funding (the “Capital Second Warrants”); and (vi) warrants representing a fee, if any, vesting only in the event of a voluntary or mandatory prepayment as described above and at a percentage as described above of each Lender’s then outstanding principal balance (the “Prepayment Warrants”). In addition, as discussed above, warrants are issuable by the Company at the Maturity Date (or earlier upon voluntary or mandatory prepayment as described above) as payment for accrued interest on the Initial Notes (the “Interest Warrants”).

The securities issued by the Company at the closing of the Interim Funding consisted of: (i) warrants representing a fee of 0.75% of each Lender’s revised, as applicable, commitment pursuant to the Interim Loan Agreement (the “Commitment Supplemental Warrants”); (ii) warrants representing a fee of 1.25% of each Lender’s loan amount in the Interim Funding (the “Origination Interim Warrants”); (iii) warrants representing 25% coverage of each Lender’s loan amount in the Interim Funding (the “Capital Interim Warrants”); (iv) warrants representing a fee of 1.25% of each Lender’s loan commitment amount, if any, in a Second Funding, vesting on September 30, 2026 only upon the occurrence of a Second Funding (the “Origination Restated Second Warrants”); (v) warrants representing 25% coverage of each Lender’s loan commitment amount, if any, in a Second Funding, vesting on September 30, 2026 only upon the occurrence of a Second Funding (the “Capital Restated Second Warrants”); and (vi) warrants representing a fee, if any, vesting only in the event of a voluntary or mandatory prepayment as described above and at a percentage as described above of each Lender’s then outstanding principal balance (the “Prepayment Restated Warrants”). In addition, Interest Warrants are issuable by the Company at the Maturity Date (or earlier upon voluntary or mandatory prepayment as described above) as payment for accrued interest on the Interim Notes.

The securities, as applicable pursuant to the Amendment, issued by the Company at the closing of the Second Funding consisted of: (i) warrants representing Commitment Warrants, Origination Restated Second Warrants and Capital Second Restated Warrants; and (ii) Prepayment Restated. Warrants. In addition, Interest Warrants are issuable by the Company at the Maturity Date (or earlier upon voluntary or mandatory prepayment as described above) as payment for accrued interest on the Second Notes.

Except as described above, each of the warrants issued and issuable under the Loan Agreement contains similar material terms. The exercise price of each of the warrants is $1.50 per share of the Company’s common stock. The determination of the number of shares issuable upon exercise of each of the warrants is calculated based upon the same $1.50 exercise price. Each of the warrants contains provisions for anti-dilution and certain other adjustments, such as due to stock dividends, stock splits, and reverse stock splits. The expiration date of each warrant is January 23, 2031 (the “Expiration Date”), which is five years from the closing date of the Initial Funding. Subject to the vesting provisions described above, each of the warrants is exercisable at any time, or from time to time up to and including the Expiration Date, by (a) making a cash payment equal to the exercise price multiplied by the quantity of shares, or (b) on a cashless basis by receiving a net number of shares calculated pursuant to the formula set forth in the warrant, provided that the shares issuable upon exercise are not registered for sale under the Securities Act of 1933, as amended.

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Accordingly, as a result of the Initial Funding, Interim Funding, and Second Funding, the Company issued securities representing: (i) Commitment Warrants, Origination Initial Warrants, and Capital Initial Warrants (together, the “Initial Warrants”) immediately exercisable for an aggregate of 148,000 shares; (ii) Commitment Supplemental Warrants, Origination Interim Warrants, and Capital Interim Warrants (together, the “Interim Warrants”) immediately exercisable for an aggregate of 120,125 shares; (iii) Origination Second Warrants and Capital Second Warrants (together, the “Second Warrants”), which vested upon the Second Funding, exercisable for an aggregate of 43,750 shares; (iv) Origination Restated Second Warrants and Capital Restated Second Warrants (together, the “Second Restated Warrants”), which vested upon the Second Funding, exercisable for an aggregate of 13,125 shares, and (v) Prepayment Restated Warrants, vesting upon a voluntary or mandatory prepayment event as described above, exercisable for an aggregate of up to 36,665 shares. Further, the Company has agreed to issue Interest Warrants at the Maturity Date (or earlier upon voluntary or mandatory prepayment as described above) immediately then exercisable for an aggregate of up to 303,667 shares representing the maximum interest payable for the maximum principal amount of $2.0 million and then repaid by the Maturity Date per the terms of the Loan Agreement.

Inflation

The Company believes that the rates of inflation in recent years have not had a significant impact on its operations.

Off-Balance Sheet Arrangements

The Company does not have any off-balance sheet arrangements.

Critical Accounting Policies and Estimates

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. 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 or estimates identified as critical. There have been no material changes to our critical accounting policies or estimates since December 31, 2025.

Item 3. Quantitative and Qualitative Disclosures About Market Risk

Not applicable.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

Under the supervision of and with the participation of our management, including our Chief Executive and Financial Officer, who is our principal executive officer and principal financial officer, we conducted an evaluation of the effectiveness of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report. The term “disclosure controls and procedures,” as set forth in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

Based on the evaluation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report, we concluded that, as of such date, our disclosure controls and procedures were not effective due to the existence of the material weaknesses previously disclosed in our Annual Report as described below under “Material Weaknesses” and “Remediation Plan.”

Notwithstanding the conclusion that our disclosure controls and procedures as of the end of the period covered by this Quarterly Report were not effective, management believes that the consolidated financial statements and related financial information included in this Quarterly Report fairly present in all material respects our financial condition, results of operations and cash flows as of the dates presented, and for the periods ended on such dates, in conformity with GAAP.

Material Weaknesses

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis. In connection with the preparation of our Annual Report and the consolidated financial statements and related disclosures therein, management identified the following material weaknesses.

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Beginning in mid-2019, we ceased ongoing operational activities and terminated all our financial accounting and reporting resources as we worked to reach a favorable outcome to Medicare reimbursement coverage for the Aurix System. When we re-started commercial operations in 2022 and as disclosed since our Annual Report for the year ended December 31, 2021, we had not hired and did not maintain a sufficient complement of accounting and financial reporting resources. The lack of sufficient accounting and financial reporting resources also prevented us from maintaining appropriately designed, and monitoring the effectiveness of, internal control over financial reporting.

Remediation Plan

Beginning in 2022, we have engaged outside consultants to assist with various accounting and financial reporting matters, and we will continue assessing the need for hiring additional internal accounting and third-party financial reporting resources. As we continue to obtain additional financial resources and continue to increase our operating activity, management, under the oversight of the Audit Committee of the Board of Directors, intends to implement further measures designed to improve our internal control over financial reporting to remediate the identified material weaknesses, namely, to identify and engage, through internal hiring and the use of external third parties, a sufficient complement of accounting and financial reporting resources and to periodically assess the design and operating effectiveness of our internal controls.

While we believe that these efforts will improve our internal control over financial reporting, the implementation of these measures is ongoing and will continue to require validation and testing of the design and operating effectiveness of internal controls over a sustained period of financial reporting cycles. We cannot assure you that the measures we have taken to date, or that we may take in the future, will be sufficient to remediate the material weaknesses we have identified or avoid potential future material weaknesses.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting during the quarter ended September 30, 2026 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II

OTHER INFORMATION

Item 1.

Legal Proceedings.

There are currently no claims or actions pending against us, the ultimate disposition of which could have a material adverse effect on our results of operations, financial condition, or cash flows.

Item 1A.

Risk Factors.

Except as described below in this Item 1A, there have been no material changes from the risk factors as previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025.

We Have Experienced an Interruption in the Supply of a Reagent Component of the Aurix System, and Future or Continuing Interruptions of Any Reagent Component Could Have a Material Adverse Effect on our Business.

Due to the TJMI supply interruption, the Aurix product entered a temporary out-of-stock situation for approximately two weeks in early August 2026.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

During the three months ended September 30, 2026, the Company issued an aggregate of 22,189 shares of its common stock to a service provider as compensation for professional services rendered to the Company. The shares were issued in monthly installments valued at $7,500 each, representing an aggregate transaction value of $22,500.

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No cash proceeds were received by the Company in connection with these issuances. The issuances of these securities were deemed to be exempt from registration under the Securities Act of 1933, as amended (the "Securities Act"), in reliance on Section 4(a)(2) of the Securities Act, as transactions by an issuer not involving a public offering. The recipient represented their intention to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends were affixed to the share certificates issued in these transactions.

Item 3.

Defaults Upon Senior Securities.

None.

Item 4.

Mine Safety Disclosures.

Not applicable.

Item 5.

Other Information.

During the quarter ended September 30, 2026, none of our directors or executive officers adopted, modified or terminated a "Rule 10b5-1 trading arrangement" or a "non-Rule 10b5-1 trading arrangement" as such terms are defined under Item 408 of Regulation S-K.

Item 6.

Exhibits.

Exhibit Number		Description

3.1		Second Amended and Restated Certificate of Incorporation of Nuo Therapeutics, Inc. (previously filed on May 10, 2016 as Exhibit 3.1 to the registrant’s Registration Statement on Form 8-A and incorporated by reference herein).

3.2		Certificate of Designation of Series A Preferred Stock of Nuo Therapeutics, Inc. (previously filed on May 10, 2016 as Exhibit 3.3 to the registrant’s Current Report on Form 8-K and incorporated by reference herein).

3.3		Certificate of Amendment to the Second Amended and Restated Certificate of Incorporation of Nuo Therapeutics, Inc. (previously filed on September 5, 2018 as Exhibit 3.1 to the registrant’s Current Report on Form 8-K and incorporated by reference herein).

3.4		Amended and Restated By-Laws of Nuo Therapeutics, Inc. (previously filed on May 10, 2016 as Exhibit 3.2 to the registrant’s Registration Statement on Form 8-A and incorporated by reference herein).

4.1		Form of Second Restated Warrants (as issued in connection with Loan and Security Agreement dated as of May 29, 2026) (previously filed on June 3, 2026 as Exhibit 4.3 to the registrant's Current Report on Form 8-K and incorporated herein by reference)

4.2		Form of Prepayment Restated Warrants (as issued in connection with Loan and Security Agreement dated as of May 29, 2026) (previously filed on June 3, 2026 as Exhibit 4.5 to the registrant's Current Report on Form 8-K and incorporated herein by reference)

4.3		Form of Interest Warrants (as issuable in connection with Loan and Security Agreement dated as of January 21, 2026) (previously filed on January 26, 2026 as Exhibit 4.4 to the registrant's Current Report on Form 8-K and incorporated by reference herein)

10.1		Amended and Restated Loan and Security Agreement, dated as of May 29, 2026 (previously filed on June 3, 2026 as Exhibit 10.1 to the registrant's Current Report on Form 8-K and incorporated herein by reference)

10.2		Assignment, Joinder, and Amendment No. 1 to Amended and Restated Loan and Security Agreement, dated as of October 6, 2026 (previously filed on October 6, 2026 as Exhibit 10.2 to the registrant’s Current Report on Form 8-K and incorporated herein by reference)

31		Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32		Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101		The following materials from Nuo Therapeutics, Inc. Form 10-Q for the quarter ended September 30, 2026, formatted in Inline Extensible Business Reporting Language (Inline XBRL): (i) Consolidated Balance Sheets at September 30, 2026 and December 31, 2025, (ii) Consolidated Statements of Operations for the three and nine month periods ended September 30, 2026 and 2025, (iii) Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the three and nine month periods ended September 30, 2026 and 2025, (iv) Consolidated Statements of Cash Flows for the nine month periods ended September 30, 2026 and 2025 and (v) Notes to the Unaudited Consolidated Financial Statements.

104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

		NUO THERAPEUTICS, INC.

Date: November 13, 2026
	By:	/s/ David E. Jorden
		David E. Jorden Chief Executive and Financial Officer
		(Principal Executive and Financial Officer)