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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 June 30, 2025

☐	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<br> Incorporation or Organization)	(IRS Employer<br> 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 July 29, 2025, the number of shares outstanding of the registrant’s common stock, $0.0001 par value, was 46,830,788.

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NUO THERAPEUTICS, INC.

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	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	14
Item 3. Quantitative and Qualitative Disclosures About Market Risk	20
Item 4. Controls and Procedures	20
PART II. OTHER INFORMATION
Item 1. Legal Proceedings	22
Item 1A. Risk Factors	22
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	22
Item 3. Defaults Upon Senior Securities	22
Item 4. Mine Safety Disclosures	22
Item 5. Other Information	22
Item 6. Exhibits	23
Signatures	24

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PART I

FINANCIAL INFORMATION

Item 1. Consolidated Financial Statements

NUO THERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEETS

(Unaudited)

			December 31,<br><br> <br>2024
ASSETS	****	****	****	****	****
Current assets	****	****	****	****	****
Cash	316,354		$	283,714
Accounts receivable, net	320,440			248,205
Inventory, net	165,816			150,442
Prepaid expenses and other current assets	50,670			159,185
Total current assets	853,280		****	841,546
Property and equipment, net	370,170			177,022
Operating lease right of use assets	136,035			170,940
Total assets	1,359,485		$	1,189,508
LIABILITIES AND STOCKHOLDERS' EQUITY/(DEFICIT)	****	****	****	****	****
Current liabilities	****	****	****	****	****
Accounts payable	312,884		$	219,190
Accrued expenses	314,554			292,400
Deferred revenue	300,000			-
Current portion of operating lease liabilities	71,517			66,861
Total current liabilities	998,955		****	578,451
Deferred revenue – long term	1,125,000			-
Non-current portion of operating lease liabilities	60,091			97,345
Total liabilities	2,184,046		****	675,796
Commitments and contingencies (Note 8)
Stockholders' equity/(deficit)	****	****	****	****	****
Common stock; 0.0001 par value, 100,000,000 shares authorized, 46,826,478 and 46,816,114 shares issued and outstanding at June 30, 2025 and December 31, 2024, respectively	4,683			4,682
Additional paid-in capital	32,826,519			32,768,976
Accumulated deficit	(33,655,763	)		(32,259,946	)
Total stockholders' equity/(deficit)	(824,561	)	****	513,712
Total liabilities and stockholders' equity/(deficit)	1,359,485		$	1,189,508

All values are in US Dollars.

See accompanying notes to unaudited consolidated financial statements.

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NUO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	Three Months<br><br> <br>ended<br><br> <br>June 30,<br><br> <br>2025			Three Months<br><br> <br>ended<br><br> <br>June 30,<br><br> <br>2024
Revenue	****	****	****	****	****	****
Product sales	$	625,202		$	364,773
License revenue		75,000			-
Total revenue	****	700,202		****	364,773
Costs of sales		159,350			65,335
Gross profit	****	540,852		****	299,438
Operating expenses	****	****	****	****	****	****
Selling, general and administrative		1,192,874			841,420
Total operating expenses	****	1,192,874		****	841,420
Loss from operations	****	(652,022	)	****	(541,982	)
Other income (expense)	****	****	****	****	****	****
Interest income (expense), net		1,153			541
Other income		1,180			1,350
Total other income (expenses)	****	2,333		****	1,891
Net loss	$	(649,689	)	$	(540,091	)
Loss per common share				****	****	****
Basic and diluted	$	(0.01	)	$	(0.01	)
Weighted average common shares outstanding				****	****	****
Basic and diluted		46,823,111			44,657,742

See accompanying notes to unaudited consolidated financial statements.

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NUO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

	Six Months<br><br> <br>ended<br><br> <br>June 30,<br><br> <br>2025			Six Months<br><br> <br>ended<br><br> <br>June 30,<br><br> <br>2024
Revenue	****	****	****	****	****	****
Product sales	$	1,109,583		$	599,350
License revenue		75,000			-
Total revenue	****	1,184,583		****	599,350
Costs of sales		280,371			115,926
Gross profit	****	904,212		****	483,424
Operating expenses	****	****	****	****	****	****
Selling, general and administrative		2,301,381			1,734,652
Total operating expenses	****	2,301,381		****	1,734,652
Loss from operations	****	(1,397,169	)	****	(1,251,228	)
Other income (expense)	****	****	****	****	****	****
Interest income (expense), net		(442	)		1,006
Other income		1,794			1,350
Total other income (expenses)	****	1,352		****	2,356
Net loss	$	(1,395,817	)	$	(1,248,872	)
Loss per common share				****	****	****
Basic and diluted	$	(0.03	)	$	(0.03	)
Weighted average common shares outstanding				****	****	****
Basic and diluted		46,819,632			44,449,629

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 Three Months and Six Months Ended June 30, 2025 and 2024

	Common Stock			****	****	****	****	****	****	****	****
	Shares		Amount <br> (par<br> 0.0001)	Additional<br><br> <br>Paid-In<br><br> <br>Capital		Accumulated<br><br> <br>Deficit			Stockholders'<br><br> <br>Equity/(Deficit)
Balance, January 1, 2025	****	46,816,114		$	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		$	32,788,319	$	(33,006,074	)	$	(213,073	)
Stock compensation expense		-			23,201		-			23,201
Issuance of common stock for services provided		10,364			14,999		-			15,000
Net loss		-			-		(649,689	)		(649,689	)
Balance, June 30, 2025	****	46,826,478		$	32,826,519	$	(33,655,763	)	$	(824,561	)

All values are in US Dollars.

	Common Stock			****	****	****	****	****	****	****	****	****
	Shares		Amount<br> (par <br> 0.0001)	Additional<br><br> <br>Paid-In<br><br> <br>Capital			Accumulated<br><br> <br>Deficit			Stockholders’<br><br> <br>Equity
Balance, January 1, 2024	****	44,241,516		$	30,970,965		$	(29,936,241	)	$	1,039,148
Stock compensation expense		-			3,081			-			3,081
Net loss		-			-			(708,781	)		(708,781	)
Balance, March 31, 2024	****	44,241,516		$	30,974,046		$	(30,645,022	)	$	333,448
Issuance of common stock for cash proceeds		867,833			650,788		****	-			650,875
Issuance of common stock for warrant exercise		270,000			151,173		****	-			151,200
Issuance of common stock for cashless warrant exercise		86,889			(9	)	****	-			-
Stock compensation expense		-			3,081		****	-			3,081
Net loss		-			-			(540,091	)		(540,091	)
Balance, June 30, 2024	****	45,466,238		$	31,779,079		$	(31,185,113	)	$	598,513

All values are in US Dollars.

See accompanying notes to unaudited consolidated financial statements.

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NUO THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

	For the Six Months Ended<br><br> <br>June 30,
	2025			2024
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(1,395,817	)	$	(1,248,872	)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation expense		38,403			7,535
Stock-based compensation		42,544			6,162
Provision for credit losses		12,525			17,500
Provision for inventory obsolescence		9,119			-
Vendor expense settled in shares of common stock		15,000			-
Amortization of operating lease right of use assets		34,905			39,887
Changes in operating assets and liabilities:
Accounts receivable, net		(84,760	)		(71,768	)
Inventory, net		(24,493	)		(7,227	)
Prepaid expenses and other current assets		108,515			(5,230	)
Accounts payable		93,694			3,125
Accrued expenses		22,154			41,655
Deferred revenue		1,425,000			-
Operating lease liabilities		(32,598	)		(36,383	)
Net cash provided by (used in) operating activities		264,191			(1,253,616	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment		(231,551	)		(4,100	)
Net cash used in investing activities		(231,551	)		(4,100	)
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from issuance of common stock		-			650,875
Net proceeds from warrant exercise		-			151,200
Net cash provided by financing activities		-			802,075
NET INCREASE (DECREASE) IN CASH		32,640			(455,641	)
Cash, beginning of period		283,714			928,681
Cash, end of period	$	316,354		$	473,040
SUPPLEMENTAL INFORMATION	****	****	****	****	****	****
Cash paid during the period for:
Interest expense	$	2,328		$	1,687

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. 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 Principles

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, 2024, we sold 2,000,000 shares of common stock to certain accredited investors pursuant to Securities Purchase Agreements in two private placements which closed in May and September 2024 for total proceeds of $1,500,000. During the six months ended June 30, 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 for additional information. We have incurred, and continue to incur, recurring losses. As of June 30, 2025, we have an accumulated deficit of approximately $33.7 million and cash of approximately $0.3 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 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. The unaudited consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Even assuming we succeed in raising sufficient additional funds in the near future, we require additional capital and will 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 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.

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Basis of Presentation and Principles of Consolidation

The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). Accordingly, they do not include all the information and footnotes required by accounting principles generally accepted in the United States of America (“U.S. GAAP”). In our opinion, the accompanying unaudited consolidated financial statements include all adjustments, consisting of normal recurring adjustments, which are necessary to present fairly our financial position, results of operations and cash flows. The consolidated balance sheet at December 31, 2024, has been derived from our audited financial statements as of that date. The interim unaudited consolidated results of operations are not necessarily indicative of the results that may occur for the full fiscal year. Certain information and footnote disclosure normally included in financial statements prepared in accordance with U.S. GAAP have been omitted pursuant to instructions, rules and regulations prescribed by the SEC. We believe that the disclosures provided herein are adequate to make the information presented not misleading when these unaudited condensed consolidated financial statements are read in conjunction with the audited financial statements and notes previously included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024.

The unaudited consolidated financial statements include the accounts of the Company and its wholly owned, controlled, and inactive subsidiary Aldagen, Inc. (“Aldagen”). All significant 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 condensed consolidated financial statements, estimates are used for, but not limited to stock-based compensation, recoverability and depreciable lives of long-lived assets, 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 June 30, 2025 and December 31, 2024 is listed below.


Customer A	13	%	-
Customer B	*		16	%
Customer C	*		14	%
Customer D	*		11	%

* less than 10%

Revenues from significant customers exceeding 10% of total revenues for the three and six months ended June 30, 2025 and June 30, 2024 is listed below. All our revenue for both periods was generated within the U.S.

	Three<br><br> <br>Months<br><br> <br>Ended<br><br> <br>June 30,<br><br> <br>2025			Three<br><br> <br>Months<br><br> <br>Ended<br><br> <br>June 30,<br><br> <br>2024
Customer E		11	%		*
Customer F		11	%		-
Customer G		10	%		-
Customer C		*			25	%
Customer D		*			12	%
	Six<br><br> <br>Months<br><br> <br>Ended<br><br> <br>June 30,<br><br> <br>2025			Six<br><br> <br>Months<br><br> <br>Ended<br><br> <br>June 30,<br><br> <br>2024
---	---	---	---	---	---	---
Customer E		15	%		*
Customer G		14	%		-
Customer D		11	%		*
Customer C		*			21	%

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 established vendor relationship.

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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 accounts receivable as of June 30, 2025 and December 31, 2024 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 six month periods ending June 30, 2025 and 2024, we recorded provisions for credit losses of $12,525 and $17,500, respectively. As of June 30, 2025 and December 31, 2024, the allowance for credit losses was approximately $40,000 and $25,000, 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 June 30, 2025, our inventory consisted of approximately $94,000 of finished goods inventory and approximately $72,000 of raw materials acquired to facilitate the manufacturing of finished goods at our contract manufacturer and our warehouse/distribution facility. As of December 31, 2024, our inventory consisted of approximately $89,000 of finished goods inventory and approximately $61,000 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 six months ended June 30, 2025 we recorded a provision for inventory obsolescence of $9,119 and maintained a reserve for inventory obsolescence as of June 30, 2025 of $12,500. As of December 31, 2024, the reserve for inventory obsolescence was $18,675.

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 six years. Maintenance and repairs are charged to operations as incurred.

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.

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. The Smith+Nephew upfront distribution fee will be recognized ratably as revenue on a straight-line basis over the initial 5-year term of the Distribution Agreement.

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We provide for the sale of our products, including disposable processing sets and supplies 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.

Stock-Based Compensation

The fair value of employee stock options is measured at the date of grant. Expected volatilities for options are 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 assume that the dividend rate on our common stock will be zero. For the options granted during the six months ended June 30, 2025, we used a risk-free rate of 4.06%, an expected term of 5.5 years, and an expected stock volatility of 75%. There were no options granted during the six months ended June 30, 2024. We have elected to recognize forfeitures of stock-based awards as they occur.

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. We expect that recent tax law changes contained in the Inflation Reduction Act and CHIPS Act will not have a material impact on the provision for income taxes.

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 six months ended June 30, 2025 and 2024.

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.

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.”

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All of our potential dilutive securities are considered anti-dilutive for the six months ended June 30, 2025 and 2024. The following table sets forth the potential dilutive securities excluded from the calculation of diluted loss per share for the periods presented.


Shares underlying:
Common stock options	3,334,958	3,189,167
Stock purchase warrants	200,000	450,000
Performance shares	300,000	300,000
	3,834,958	3,939,167

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 December 2023, the FASB issued final guidance in ASU No. 2023-09, Income Taxes (ASC 740): Improvements to Income Tax Disclosures requiring entities to provide additional information in the rate reconciliation and disclosures about income taxes paid. For public business entities, the guidance is effective for annual periods beginning after December 15, 2024. We are currently evaluating the effect of the adoption of this guidance.

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:

	June 30,<br><br> <br>2025			December 31,<br><br> <br>2024
Medical equipment	$	758,527		$	538,527
Office/warehouse equipment		49,686			48,019
Warehouse/production equipment		33,200			23,317
		841,413			609,863
Less accumulated depreciation		(471,243	)		(432,841	)
Property and equipment, net	$	370,170		$	177,022

Depreciation expense was $23,056 (of which $18,543 was charged to cost of goods sold) and $3,767 for the three months ended June 30, 2025 and 2024, respectively. Depreciation expense was $38,403 (of which $29,753 was charged to cost of goods sold) and $7,535 for the six months ended June 30, 2025 and 2024, respectively. None of our long-lived assets were deemed to be impaired during the three months ended June 30, 2025 and 2024.

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 six months ended June 30, 2025, we recognized the initial $75,000 of license revenue under the Distribution 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. During the 5-year initial term of the agreement commencing on the date of first sale by Smith+Nephew, minimum annual purchase commitments of an average of approximately $500,000 will apply for Smith+Nephew to maintain exclusive distribution rights.

As consideration for entering into the agreement, we received an upfront fee of $1.5 million and we are eligible for an additional $750,000 in milestone fees based on our establishment and maintenance of reimbursement in certain categories for the Aurix and the private label products. Such fees will be refundable to Smith+Nephew on a pro rata basis for the unexpired initial term of the agreement if we do not comply with certain terms and conditions. The $1.5 million distribution fee is being recognized on a pro rata basis over the initial term of the agreement and the unearned distribution fee is treated as deferred revenue.

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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 parties’ customers based on identified customer lists, and certain liability and indemnity clauses.

In connection with entering into the agreement, Smith+Nephew obtained certain additional information rights related to our business and corporate matters. In particular, we provided Smith+Nephew a right of notification and a right of first negotiation over a defined period, in the event we receive from another party a proposal for (a) the license, assignment, transfer, or disposal of our Aurix product or related products, or (b) a business combination that we submit or recommend to our stockholders. These rights continue for a limited period of the initial term of the agreement.

Note 5 – Stock Purchase Warrants

The following schedule reflects outstanding stock purchase warrants as of June 30, 2025 and June 30, 2024:

Description	June 30, 2025		June 30, 2024
2022 Sales incentive warrants		200,000		450,000
Total		200,000		450,000

During the year ended December 31, 2022, we issued two warrants to purchase (i) 250,000 shares of common stock at an exercise price of $1.00 per share and expiring December 31, 2027 and (ii) 200,000 shares of common stock at an exercise price of $1.50 per share and expiring December 31, 2028 to a distribution partner under an agreement whereby the warrants were exercisable subject to the distributor attaining certain performance goals based upon exceeding sales quota revenues for calendar years 2023 through potentially 2025. According to the warrants' vesting provisions, they will not be exercisable throughout the remainder of their term. Furthermore, the warrants shall be considered cancelled and forfeited upon a determination that the performance goals cannot be attained upon the last of the determination dates. Therefore, the warrant for 250,000 shares expiring December 31, 2027 has been removed from the tabular presentation above as the final determination date was January 15, 2025. The warrants are equity classified.

Note 6 – 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.

Pacific Medical Common Stock and Warrant Purchase Agreement

On August 24, 2022, we entered into a Common Stock and Warrant Purchase Agreement (the “Agreement”) with Pacific Medical, Inc. (“Pacific Med”) for the sale and issuance of shares of common stock and warrants to purchase shares of common stock. Pacific Med is the exclusive distributor for the Aurix products within a territory that covers the states of Washington, Oregon, Idaho, Montana, Wyoming, most of California, the northern half of Nevada, plus Alaska.

Pursuant to the Agreement, Pacific Med purchased 500,000 shares of common stock for $500,000. As part of the purchase of common stock, we agreed to grant to Pacific Med the right to participate in any future financing by Nuo through December 31, 2023 (the “Participation Rights”) in connection with a listing of our common stock on a national securities exchange. The Participation Rights entitled Pacific Med to purchase up to 500,000 shares of common stock upon substantially the same terms, conditions, and price provided for in such financing. If such a financing did not occur by December 31, 2023, we agreed to issue Pacific Med a warrant with a January 1, 2024 issuance date and exercisable until June 30, 2024, to purchase up to 500,000 shares of common stock at a price equal to the lower of $2.00 per share or the 20-day volume weighted average closing price per share ending December 31, 2023 (the “2024 Financing Participation warrant”). We issued the 2024 Financing Participation warrant to Pacific Med on January 1, 2024 with an exercise price of $0.56 per share. Pacific Med exercised (i) 270,000 of the warrants for cash proceeds of $151,200 and (ii) the remaining 230,000 warrants cashlessly in exchange for the issuance of 86,889 shares of common stock during the year ended December 31, 2024. The common stock and Participation Rights are equity classified.

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As part of the Agreement and as additional incentive compensation with respect to Pacific Med’s performance under the sales and distribution arrangement, we also provided to Pacific Med two compensatory performance-based stock purchase warrants and certain contingently issuable performance shares. The first warrant entitled Pacific Med to purchase up to 250,000 shares of common stock at a price of $1.00 per share upon Pacific Med attaining certain performance goals based upon exceeding sales quota revenue for calendar years 2023 and/or 2024. The second warrant entitles Pacific Med to purchase up to 200,000 shares of Common Stock at a price of $1.50 per share upon Pacific Med attaining certain performance goals based upon exceeding sales quota revenue for calendar years 2024 and/or 2025. The warrants will expire December 31, 2027 and December 31, 2028, respectively. However, the performance goals providing for exercisability of the warrants were not achieved and the warrants will not be exercisable throughout the remainder of their term. Furthermore, the warrants shall be considered cancelled and forfeited upon a determination that the performance goals cannot be attained upon the last of the determination dates. As a result, the warrant expiring December 31, 2027 is considered cancelled and forfeited. We also agreed to issue up to 300,000 shares of common stock to Pacific Med subject to and upon the achievement of certain milestones set forth in the Agreement based upon sales of our products over defined 12-month periods of between $4.5 million by June 30, 2024 through at least $12.5 million in calendar year 2025 (the Performance Shares”). The fair value of the Performance Shares at the date of issuance was approximately $615,000 based on the closing stock price on the closing of the Agreement. As the issuance of the shares is not considered probable as of June 30, 2025, there was no expense recognition for the six months ended June 30, 2025. When issuance is determined to be probable, the issuance date fair value of the shares through such date will be recognized with the balance of the fair value recognized ratably over the remaining period of performance.

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.

A summary of stock option activity under the Plan during the six months ended June 30, 2025 is presented below:

Stock Options – 2016 Omnibus Plan		Weighted<br><br> <br>Average Exercise Price
Outstanding at January 1, 2025	3,258,958	$	0.61	5.30
Granted	76,000		1.19	10.0
Exercised	-		-	-
Forfeited or expired	-		-	-
Outstanding at June 30, 2025	3,334,958	$	0.62	4.92
Exercisable at June 30, 2025	2,818,291	$	0.65	4.15

There were 76,000 stock options granted to an employee and a third-party consultant during the six months ended June 30, 2025. The fair value of the options to vest over three years was approximately $59,800. The aggregate intrinsic value for outstanding and exercisable options as of June 30, 2025 was approximately $2.9 million and $2.4 million, respectively. There were no options granted during the six months ended June 30, 2024.

For the three months ended June 30, 2025 and 2024, we recorded stock-based compensation expense of $23,201 and $3,081, respectively. For the six months ended June 30, 2025 and 2024, we recorded stock-based compensation expense of $42,544 and $6,162, respectively. As of June 30, 2025, there was approximately $120,500 of unrecognized compensation cost related to non-vested stock options which is expected to be recognized prior to year-end 2028.

Note 7 – 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 product sales of the Aurix product line. 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 of as a whole. The CODM does not review assets in evaluating the results of the segment, and therefore, such information is not presented.

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The following table presents the operating results of the segment:

	Three Months<br><br> <br>Ended June 30,		****	Three Months<br><br> <br>Ended June 30,		****	Six Months<br><br> <br>Ended June 30,			Six Months<br><br> <br>Ended June 30,
	2025		****	2024		****	2025			2024
Total revenues		700,202			364,773		$	1,184,583		$	599,350
Less significant segment expenses:
Cost of sales (excluding provision for inventory obsolescence and applicable depreciation expense)		140,807			65,335			241,499			115,926
Total compensation and benefit costs (including third party commission expense)		645,902			510,544			1,208,809			994,536
Provisions for credit losses and inventory obsolescence		-			-			21,644			17,500
All other operating expenses (excluding depreciation and credit loss provision)^(a)^		501,604			284,141			993,948			669,032
Other segment items:
Depreciation, amortization of right of use assets, and stock-based compensation		63,911			46,735			115,852			53,584
Interest expense (income), net		(1,153	)		(541	)		442			(1,006	)
Other expense (income), net		(1,180	)		(1,350	)		(1,794	)		(1,350	)
Consolidated net loss		(649,689	)		(540,091	)	$	(1,395,817	)	$	(1,248,872	)

(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.

Note 8 – Commitments and Contingencies

Lease Agreements

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 $28,500 and $27,400 for the three months ended June 30, 2025 and 2024, respectively. Total operating lease costs were approximately $57,500 and $63,900 for the six months ended June 30, 2025 and 2024, 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:

2025		40,136
2026		82,705
2027		21,285
Total operating lease payments		144,126
Discount factor		(12,518	)
Present value of operating lease liabilities		131,608
Current portion of operating lease liabilities		(71,517	)
Non-current portion of operating lease liabilities	$	60,091

Note 9 – Subsequent Events

Effective July 30, 2025, the Company closed on an equity private placement for the sale of 527,612 shares of common stock for gross proceeds of $791,418 to certain accredited investors under a Securities Purchase Agreement dated July 25, 2025 providing for the issuance of up to 600,000 shares of common stock.

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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, 2024 (our “Annual Report”), filed with the U.S. Securities and Exchange Commission (the "SEC") on April 1, 2025.

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 reliance on several single source suppliers and our ability to source raw materials at affordable costs;
●	our ability to protect our intellectual property;
●	our compliance with governmental regulations;
●	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;
●	the impact of and our ability to undertake any license of our Aurix product, or receive and negotiate a business combination offer, due to the binding notification and negotiation rights we have provided to 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 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 is 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 employed for a selected variety of other therapies, including transcatheter aortic valve repair and cochlear implantation. Under the 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. Under 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 will be determined by local Medicare Administrative Contractors ("MACs").

Although FDA cleared the Aurix System for marketing for wound care management in 2007 under Section 510(k) of the FDCA, CMS only established economically viable reimbursement for the product beginning in 2016. For 2025, the CMS national average reimbursement rate for the Aurix System is $1,829 per treatment in place of service ("POS") 22 (hospital outpatient departments), which we believe provides appropriate payment to facilities for product usage. The Company also 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 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.

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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 five 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 was first available in May 2022 for demonstration and evaluation purposes. Through a growing sales agent network, Aurix is presently being evaluated by various hospital Value Analysis Committees (VACs) as part of the process of approving its clinical use. While limited initial commercial revenues were recorded during the second half of 2022, revenues increased to approximately $609,000 in 2023 and further increased to approximately $1,365,000 in 2024, and we expect revenues will continue growing in the future.

As of June 30, 2025, we had established contractual relationships with more than 200 third-party entity and individual representatives including a multi-state agreement with Pacific Medical, Inc. covering multiple large markets in the western United States. The number of sales agent representatives may continue to expand modestly in the months ahead, but the current focus is establishing commercial customer relationships with wound care providers in primarily hospital outpatient wound care clinics and 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 will supply 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 sale by Smith+Nephew, minimum annual purchase commitments will apply to Smith+Nephew of an average of approximately $500,000 per year for Smith+Nephew to maintain exclusive distribution rights.

As consideration for entering into the Distribution Agreement, Smith+Nephew paid us an upfront distribution fee of $1,500,000 for distribution rights and we are also eligible to be paid by Smith+Nephew an additional $750,000 in fees based on our establishment and maintenance of reimbursement in certain categories for the Aurix and the Private Label products. These fees will be refundable to Smith+Nephew on a pro rata basis for the unexpired initial term of the Distribution Agreement if we do not comply with certain terms and conditions.

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.

The $1,500,000 upfront distribution fee will be recognized ratably as revenue on a straight-line basis over the initial five-year term of the Distribution Agreement.

We believe that Smith+Nephew will need time to establish and begin commercial sales of its Private Label product. As a result, we anticipate modest sales under the Distribution Agreement during the next 12 months. While the Distribution Agreement will provide us with revenues, we also will incur expenses at the outset of the Distribution Agreement to enable us to comply with its provisions as well as packaging, shipping, and related costs associated with delivering the Private Label product for Smith+Nephew. The amount of these expenses and costs will vary depending on the amount of purchase orders that we receive from Smith+Nephew.

On May 14, 2025, we entered into Amendment No. 1 (the “Amendment”) to the Distribution Agreement. The Amendment supplements the Distribution Agreement by additionally providing for an interim sales agency arrangement whereby Smith+Nephew is entitled to act as sales agent on an interim basis for the sale of products under the Aurix brand to certain Smith+Nephew customers. As compensation, Smith+Nephew is entitled to a commission on net sales of the Nuo branded products sold to the Smith+Nephew customers. The Amendment’s interim sales agency arrangement terminates upon the earlier of December 31, 2025 or the date notified in writing by Smith+Nephew upon not less than thirty days’ notice of such termination.

The description above of the Distribution Agreement is qualified by reference to the full text of such agreement, a copy of which was filed as Exhibit 10.1 to our Annual Report. The description above of the Amendment is qualified by reference to the full text of such agreement, a copy of which is filed as Exhibit 10.1 to this Quarterly Report and incorporated herein.

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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.

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 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.)

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●

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 approximate 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 June 30, 2025 and 2024

Revenue and Gross Profit

Total revenues for the three months ended June 30, 2025 totaled approximately $700,000 including $75,000 of license fee revenue related to the Smith+Nephew distribution agreement. Product revenues for the three months ended June 30, 2025 totaled approximately $625,000 in comparison to product and total revenues of approximately $365,000 in the three months ended June 30, 2024 representing an increase of approximately $335,000. Associated gross profit was approximately $541,000 in the three months ended June 30, 2025 in comparison to approximately $299,000 of gross profit in the three months ended June 30, 2024. The increase in revenues and gross profit was due primarily to an expanding customer base over the past year as hospital wound care facilities and providers become incrementally aware of the Aurix product and the 2021 Medicare NCD as well as the initial license fee revenue under the Smith+Nephew distribution agreement.

Operating Expenses

Total operating expenses increased approximately $352,000 to approximately $1,193,000 comparing the three months ended June 30, 2025 to the three months ended June 30, 2024. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $129,000 due largely to increased legal and accounting fees associated with the finalization of the distribution agreement with Smith+Nephew and SEC registration statements filed in the quarter, (ii) third party commission expense of approximately $68,000 for independent sales representatives and distributors resulting from increased Aurix product revenues , and (iii) third party consulting expenses of approximately $63,000 primarily for our quality management system and reimbursement support services.

Other Income (Expense)

Other income (expense), net for the three months ended June 30, 2025 and 2024 primarily represents interest income on cash balances in excess of interest expense associated with the financing of insurance premiums while other income for the three-month periods was nominal.

Comparison of Six Months Ended June 30, 2025 and 2024

Revenue and Gross Profit

Total revenues for the six months ended June 30, 2025 totaled approximately $1,184,000 including $75,000 of license fee revenue related to the Smith+Nephew distribution agreement. Product revenues for the six months ended June 30, 2025 totaled approximately $1,109,000 in comparison to product revenues of approximately $599,000 in the six months ended June 30, 2024 representing an increase of approximately $511,000. Associated gross profit was approximately $904,000 in the six months ended June 30, 2025 in comparison to approximately $483,000 of gross profit in the six months ended June 30, 2024. The increase in revenues and gross profit was due to an expanding customer base over the past year as hospital wound care facilities and providers become incrementally aware of the Aurix product and the 2021 Medicare NCD as well as the initial license fee revenue under the Smith+Nephew distribution agreement.

Operating Expenses

Total operating expenses increased approximately $567,000 to approximately $2,301,000 comparing the six months ended June 30, 2025 to the six months ended June 30, 2024. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $199,000 due largely to increased legal and accounting fees associated with the negotiation and finalization of the Smith+Nephew distribution agreement and SEC registration statements filed in the period, (ii) third party commission expense of approximately $135,000 for independent sales representatives and distributors resulting from increased Aurix product revenues, and (iii) third party consulting expenses of approximately $83,000 primarily for our quality management system and reimbursement support services.

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Other Income (Expense)

Other income (expense), net for the six months ended June 30, 2025 primarily represents interest expense associated with the financing of insurance premiums in excess of interest income on cash balances while other income for the six-month periods was nominal.

Liquidity and Capital Resources

Overview

As of June 30, 2025, we had cash balances of approximately $0.3 million, total current assets of approximately $0.9 million and total current liabilities of approximately $1.0 million. As an operational business, we have a history of losses and are not currently profitable. For the years ended December 31, 2024, and 2023, we incurred net losses of approximately $2.3 million and $3.2 million, respectively. As of June 30, 2025, our accumulated deficit was approximately $33.6 million and our stockholders’ deficit was approximately $0.8 million.

During the six-month period ended June 30, 2025, we received $1.5 million from Smith+Nephew representing the upfront distribution fee under the Distribution Agreement.

Effective January 1, 2024, pursuant to the provisions of the August 2022 Common Stock and Warrant Purchase Agreement with Pacific Medical, Inc. ("Pacific Med"), we issued Pacific Med a warrant to purchase up to 500,000 shares of common stock at a price equal to $0.56, the 20-day volume weighted average closing price per share of our common stock ending December 31, 2023. A portion of the warrant was exercised during the six-month period ended June 30, 2024 and we received proceeds of $151,200.

On May 12, 2025, the SEC declared the Company's shelf registration statement on Form S-3 effective. The shelf registration statement enables us to offer and sell, from time to time in one or more offerings, shares of our common stock with an aggregate offering amount not exceeding $15 million. The shelf registration statement could provide us with access to liquidity from the public markets should we decide to utilize it for that purpose.

During the year ended December 31, 2024, we sold 2,000,000 shares of common stock to certain accredited investors pursuant to Securities Purchase Agreements in two private placements which closed in May and September 2024 for total proceeds of $1,500,000.

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.

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:

	Six months<br><br> <br>ended<br><br> <br>June 30,<br><br> <br>2025			Six months<br><br> <br>ended<br><br> <br>June 30,<br><br> <br>2024
Cash flows provided by (used in) operating activities	$	264,191		$	(1,253,616	)
Cash flows used in investing activities	$	(231,551	)	$	(4,100	)
Cash flow provided by financing activities	$	-		$	802,075

Operating Activities

Cash provided by operating activities for the six months ended June 30, 2025 of approximately $264,000 primarily reflects our net loss of approximately $1,396,000 adjusted by (i) the $1,425,000 increase in deferred revenues (ii) approximately $83,000 net change in operating assets and liabilities (excluding deferred revenue), and (iii) approximately $116,000 in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation. The deferred revenue is due to the receipt of the $1.5 million upfront distribution fee from Smith+Nephew in conjunction with the private label distribution agreement which was effective as of March 31, 2025.

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Cash used in operating activities for the six months ended June 30, 2024 of approximately $1,254,000 primarily reflects our net loss of approximately $1,249,000 adjusted by (i) approximately $76,000 net change in operating assets and liabilities, (ii) approximately $53,600 total depreciation and amortization expense and stock-based compensation expense and (iii) a provision for credit losses of $17,500.

Investing Activities

Cash used in investing activities for the six months ended June 30, 2025 primarily represents $220,000 in expenditures for the purchase of centrifuge devices.

We had limited investing activities for the six months ended June 30, 2024.

Financing Activities

We did not have any financing activities for the six months ended June 30, 2025.

Cash from financing activities for the six months ended June 30, 2024 reflects proceeds of (i) $650,875 from the sale of 867,833 shares of common stock in a private placement closed in May 2024 and (ii) $151,200 from the exercise of 270,000 warrants in June 2024.

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

Our unaudited condensed consolidated financial statements included in Part I, Item 1 of this Quarterly Report are prepared in conformity with U.S. GAAP, which require us to make estimates and assumptions regarding future events that affect the amounts reported in our financial statements and accompanying notes. We base these estimates on our experience and assumptions regarding future events we believe to be reasonable under the circumstances. Actual results could differ from those estimates and such differences may be material to the unaudited condensed consolidated financial statements. We have described our most critical accounting policies in the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” section of our Annual Report. There were no accounting policies identified as critical. There have been no material changes to our critical accounting policies or estimates since December 31, 2024.

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.

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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.

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, the Company 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 the Company from maintaining appropriately designed, and monitoring the effectiveness of, internal control over financial reporting.

Remediation Plan

Beginning in 2022, the Company engaged outside consultants to assist with various accounting and financial reporting matters and will continue assessing the need for hiring additional internal accounting and third-party financial reporting resources. As additional financial resources are obtained and we increase our operating activity, management, under the oversight of the Audit Committee of the Board of Directors, will continue to implement 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 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 June 30, 2025 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.

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, 2024.

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

None.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Entry into a Material Definitive Agreement; Unregistered Sales of Equity Securities

On July 30, 2025, the Company entered into a Securities Purchase Agreement, dated as of July 25, 2025, with certain accredited investors for the sale of 527,612 shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”) at a price of $1.50 per share for gross proceeds of $791,418 (the “Private Placement”). The closing of the Private Placement also occurred on July 30, 2025.

The investors in the Private Placement included Scott M. Pittman, a member of the Board of Directors of the Company and Charles E. Sheedy, a principal stockholder of the Company of the Company. Messrs. Pittman and Sheedy invested $5,919 and $200,000, respectively, in the Private Placement.

The proceeds of the Private Placement will be used for working capital purposes.

The description of the Securities Purchase Agreement is qualified in its entirety by reference to the full text of such agreement filed as Exhibit 10.2 hereto.

The shares of Common Stock were offered and sold in the Private Placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended, and Rule 506 thereunder, in a transaction not involving any public offering.

Insider Trading Arrangements

During the quarter ended June 30, 2025, 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.

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Item 6. Exhibits.

Exhibit<br><br> <br>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).
10.1	Amendment No. 1 to Distribution Agreement between Smith & Nephew, Inc. and Nuo Therapeutics, Inc. dated May 14, 2025#
10.2	Securities Purchase Agreement dated July 25, 2025
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 June 30, 2025, formatted in Inline Extensible Business Reporting Language (Inline XBRL): (i) Consolidated Balance Sheets at June 30, 2025 and December 31, 2024, (ii) Consolidated Statements of Operations for the three and six month periods ended June 30, 2025 and 2024, (iii) Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the three and six month periods ended June 30, 2025 and 2024, (iv) Consolidated Statements of Cash Flows for the six month periods ended June 30, 2025 and 2024 and (v) Notes to the Unaudited Consolidated Financial Statements.
104	Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

Certain portions have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K by means of marking such portions with brackets (“[****]”) because the identified confidential portions are not material and are the type of information that the registrant treats as private or confidential.

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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: July 31, 2025
	By:	/s/ David E. Jorden
		David E. Jorden<br><br> <br>Chief Executive and Financial Officer
		(Principal Executive and Financial Officer)

ex_844324.htm

Exhibit 10.1

[****] = Certain confidential information contained in this document, marked by brackets, has been omitted because the information is not material and is the type of information that the registrant treats as private or confidential

AMENDMENT NO. 1 TO

DISTRIBUTION AGREEMENT

The parties named below agree as follows:

This Amendment Number 1 (Amendment) to Distribution Agreement with an Effective Date of March 31^st^ 2025 (including any amendments) (Agreement) between Smith & Nephew, Inc. (S+N) and Nuo Therapeutics, Inc. (NUO) shall take effect on and from May 14, 2025.

Capitalized terms in this Amendment have the meanings given them in the Agreement unless the context otherwise requires.

	For SMITH + NEPHEW	For NUO
Parties:<br><br> <br><br><br> <br>Address:	Smith & Nephew, Inc. (S+N)<br><br> <br><br><br> <br>150 Minuteman Rd<br><br> <br><br><br> <br>Andover, MA 01810	Nuo Therapeutics, Inc. (NUO)<br><br> <br><br><br> <br>8285 El Rio, Suite 190<br><br> <br><br><br> <br>Houston, TX 77054
Signatures:	/s/ Ted Melo<br><br> <br><br><br> <br>Printed Name: Ted Melo<br><br> <br><br><br> <br>Title: SVP Finance Global Wound<br><br> <br><br><br> <br>Date Signed: May 14, 2025	/s/ David Jorden<br><br> <br><br><br> <br>Printed Name: David Jorden<br><br> <br><br><br> <br>Title: CEO/CFO<br><br> <br><br><br> <br>Date Signed: May 14, 2025
1.	The Parties hereby agree that the Agreement shall be amended as follows:
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a)	The S+N Customer List in Schedule 3, Annex E of the Agreement shall be deleted and replaced with the S+N Customer List in Annex 1 of this Amendment.
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b)	a new Section 1.10 shall be added to the Agreement as follows:

Section 1.10:

Interim Sales Agency commencing on May 14, 2025, the Parties agree S+N shall be entitled to act as sales agent on an interim basis for sale of Products under the NUO Brand to certain S+N Customers, such customers as further specified in Schedule 8 of the Agreement. A new Schedule 8 (Interim Sales Agency Customers) shall be appended to the Agreement in the format set out in Appendix 2 of this Amendment.

1.10.1

a)	S+N and NUO agree with a view to enabling adoption of Products under the S+N Brand, in customer accounts pending launch of such Products being available for sale and distribution under the terms of the Agreement, that S+N, its employees and contractors (S+N) acting as sales agents on an interim basis, shall be permitted by NUO to promote, solicit, service and support sales of Products under the NUO Brand to certain S+N Customers as further specified in Schedule 8. S+N shall not be obligated to solicit any specific volume or value of sales and shall maintain full discretion and independence as to its promotional, solicitation and service activities.
b)	S+N shall be entitled to payment of a commission for Product sales concluded as a result of its sales agent activities as further specified below.
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c)	The arrangements for Interim Sales Agency in this Section 1.10 shall terminate on the earlier of: i) December 31^st^ 2025; or ii) the date notified by S+N in writing, provided S+N shall provide not less than thirty (30) days’ notice of such termination.
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d)	The Parties acknowledge and agree that for the purposes of this Section 1.10:
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(i)	S+N shall operate an independent business and shall have all rights and responsibilities of an independent contractor,
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(ii)	S+N shall be acting as and furnishing its services to NUO as an independent contractor at all times; and
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(iii)	(iii) nothing in this Section 1.10, establishes or is intended to establish an employer-employee relationship, manufacturer-distributor relationship, partnership, franchise, joint venture or anything other than an independent contractor relationship between S+N and NUO.
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e)	The Parties expressly waive application of any franchise laws that may exist in any applicable jurisdiction. Other than as expressly permitted by this Section 1.10, the Parties agree that no Party will hold itself out as a legal representative of the other Party, and no Party has the authority to contract on behalf of or in the name of the other Party or legally bind the other Party for any other purpose. No Party to this Section 1.10 will be liable to any third party in any way for any engagement, obligation, contract, representation or transaction of the other Party.
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f)	The Parties agree that NUO shall be the sole vendor of record for the Products under the NUO Brand for the purposes of this Section 1.10 (NUO Products) and responsible for the sale of NUO Products to the S+N Customers concluded pursuant to this Section 1.10, including, but not limited to, manufacturing and supplying the NUO Products, invoicing customers for Product sales, shipping Products, collecting receivables and amounts due for the Products and warranting and replacing Products consistent with industry standards and practices. NUO shall recognize all revenue attributable to the sale of NUO Products under this Section 1.10 (other than any income recognized by S+N from the receipt of commission payments pursuant to the paragraphs of this Section 1.10 below).
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g)	NUO shall have sole authority over pricing of the NUO Products but agrees to provide market competitive pricing, discounts and terms of service to customers that are similar to the pricing, discounts and terms of service NUO offers to similarly-situated customers with comparable committed levels, product use and purchase volumes. NUO shall promptly approve any price quotes prepared by S+N. Any discounting of the NUO Products will only be offered by, applied by, or as authorized by NUO. Where applicable and subject to any confidentiality obligations owed to third-parties, the Parties will make good faith efforts to collaborate on responses to requests for proposals and other customer contract offerings involving the NUO Products and agree to share related information as required to satisfy customer quote/pricing requirements for the NUO Products.
h)	NUO will promptly process all NUO Product orders solicited by S+N. NUO will invoice customers directly and sell the NUO Products in accordance with the terms of the purchase order or contract entered between NUO and the S+N Customer.
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i)	For the avoidance of doubt, S+N agrees that it is not authorized to sell the Products, or otherwise receive any compensation for the NUO Product sales, except as provided by this Agreement, and S+N and its Affiliates shall not be responsible for or have any liability to NUO or any third parties for sales of the NUO Products.
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j)	For the duration of the operation of the Interim Sales Agency in accordance with this Section 1.10, NUO shall communicate directly with S+N regarding the NUO Products and the subject matter of this Section 1.10 and not with the S+N Customers unless otherwise approved by S+N.
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k)	NUO will provide all such training, promotional, marketing and sales support (including promotional materials and supporting documentation as S+N may reasonably require at no cost to S+N), as S+N may reasonably request from time to time in connection with this Section 1.10.
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l)	For purposes of this Section 1.10, NUO grants to S+N, a royalty-free, nationwide, non-transferrable and non-exclusive license to use the trade names and trademarks owned by or licensed to NUO associated with the NUO Products. The NUO Brand and packaging to be affixed to the NUO Products is shown in the depiction of the NUO Get Up and S+N shall be permitted to use the NUO Brand and NUO Get Up in connection with the promotion, solicitation, service and support of NUO Product sales during the term of the Interim Sales Agency.
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m)	Upon termination of the Interim Sales Agency in accordance with this Section 10.10, this Section 1.10 shall cease to apply in its entirety save for any outstanding obligations pursuant to Section 1.10.3 or as relates to NUO’s conclusion of any outstanding S+N Customer orders or the provision of support to S+N Customers who have purchased NUO Products.
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n)	In the event of any conflict between the terms and conditions of this Section 1.10 and the Agreement or any other Schedules pursuant to the Agreement, this Section 1.10 and Schedule 8 shall take precedence and shall control with regards to their subject matter only.
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1.10.2

Both Parties will (i) comply with all applicable federal, state and local laws, rules and regulations, including without limitation those relating to payments or reimbursements in connection with federal healthcare programs, including the Anti-Kickback Statute, the Stark Law regulation, the Foreign Corrupt Practices Act (FCPA), the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its accompanying regulations, the Sunshine Act, prohibitions on off-label promotion of any Products, and related policies including AdvaMed’s Code of Ethics; (ii) **** cooperate in any investigation relating to activities of the Parties under this Agreement, including investigations relating to fraud and abuse issues; and (iii) not solicit, engage, compensate, remunerate or otherwise induce a surgeon, health care provider or professional, hospital, medical institution, or any employee or agent of any educational or health care organization to purchase the NUO Products as consideration for becoming a consultant for either of the Parties.

b)	Each of the Parties represents and warrants that it is not currently excluded, debarred, suspended or otherwise ineligible to participate in federal health care programs or in federal procurement or non-procurement programs. Each of the Parties represents and warrants that its employees or other personnel, agents, subsidiaries and affiliated entities, if any, are not currently excluded, debarred, suspended or otherwise ineligible to participate in federal health care programs or in federal procurement or non-procurement programs.
c)	To the extent permitted by applicable law and regulations, each of the Parties represents and warrants that it will notify the other as soon as reasonably possible if it, or any of its employees or other personnel, agents, subsidiaries or affiliated entities, if any, becomes excluded, debarred, suspended, or otherwise ineligible to participate in federal health care programs or in federal procurement or non-procurement programs.
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d)	NUO will be responsible for and shall exclusively manage any and all reporting to the United States Food and Drug Administration (FDA) and other governing bodies regarding the performance of the NUO Products or adverse events potentially attributed to the NUO Products. S+N will inform NUO in writing of any complaints regarding the Products, of which S+N becomes aware without delay, so that NUO may timely investigate and report such complaints as required by applicable laws and regulations. S+N will cooperate and provide NUO with information and assistance with respect to the investigation of any such complaint they report as NUO reasonably requires to investigate and address such matter.
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e)	If any governmental or similar entity issues a request, directive or order to recall or withdraw the NUO Products, or if NUO determines in its discretion that any NUO Products be recalled or withdrawn, NUO will be solely responsible, as between NUO and S+N, for such recall or withdrawal of the NUO Products, including without limitation, all customer refunds for the NUO Products, NUO Product replacements and S+N’s costs incurred as a result of such recall. S+N, at NUO’s expense, will cooperate with NUO in conducting such recall or withdrawal and assist NUO to the extent necessary to ensure that the recall or withdrawal is effective. S+N will assist in promptly executing NUO Product recalls as directed by NUO, in which event NUO will reimburse S+N for all documented, reasonable, out-of-pocket expenses incurred by S+N to comply with NUO directives in connection with the Products subject to recall.
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1.10.3

S+N shall be entitled to payment of a [****] commission on NUO Product sales as follows:

a)	NUO shall pay to S+N, the commissions as set out above on Net Sales of the NUO Products, resulting from S+N’s (including its employees’ and contractors’) efforts to promote, solicit, service and support the NUO Products to the Interim Sales Agency Customers. Net Sales means the gross amounts invoiced by NUO to the S+N Customers, less returns, credit memos, rebates and other allowances actually made and other administrative fees, and/or sales, value-added or similar taxes (as applicable).
b)	Commissions will be deemed earned and payable to S+N upon NUO invoicing of the applicable NUO Product order to the S+N Customer. Commission payments due to S+N shall be calculated monthly by NUO and paid to S+N in arrears [****] in which the NUO Products are invoiced to the S+N Customers.
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NUO shall pay to S+N, the commissions as set out above on Net Sales of the NUO Products, resulting from S+N’s (including its employees’ and contractors’) efforts to promote, solicit, service and support the NUO Products to the Interim Sales Agency Customers. Net Sales means the gross amounts invoiced by NUO to the S+N Customers, less returns, credit memos, rebates and other allowances actually made and other administrative fees, and/or sales, value-added or similar taxes (as applicable).

Commissions will be deemed earned and payable to S+N upon NUO invoicing of the applicable NUO Product order to the S+N Customer. Commission payments due to S+N shall be calculated monthly by NUO and paid to S+N in arrears [****] in which the NUO Products are invoiced to the S+N Customers.

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c)	NUO agrees that it will not withhold invoices for NUO Product sales or fail to pursue open orders in a manner which artificially skews orders or commission payments into or away from a particular calendar month. For any commission payments made to S+N, NUO shall provide monthly sales reports (Monthly Reports) to S+N that provide the details of all NUO Product sales to customers resulting from S+N’s efforts to promote, solicit, service and support the NUO Products. At a minimum, such Monthly Reports should provide the (i) invoice date for each NUO Product sale and status of customer payment, (ii) customer and facility name, (iii) type and quantity of NUO Products sold, (iv) S+N representative responsible for the order, and (v) calculation of any commissions paid, or scheduled to be paid, to S+N. NUO acknowledges that all decisions regarding the compensation S+N will pay to its employees or contractors will be determined by S+N. Upon reasonable request, NUO shall provide S+N with appropriate sales and other pertinent information on a monthly basis with respect to its calculation of and any adjustments to commission payments.
2.	This Amendment shall form part of the Agreement and shall modify and supersede all inconsistent terms and provisions set out in the Agreement. In the event of any inconsistencies between this Amendment and the Agreement, the terms of this Amendment shall prevail and control. Except as stated in this Amendment, all other provisions of the Agreement shall remain in full force and effect.
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3.	This Amendment may be executed in counterparts and each counterpart is an original of this Amendment.
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ex_844169.htm

Exhibit 10.2

SECURITIES PURCHASE AGREEMENT

This Securities Purchase Agreement, dated on and as of July 25, 2025, (this “Agreement”), is made by and among Nuo Therapeutics, Inc., a Delaware corporation (the “Company”), and the undersigned purchasers (each a “Purchaser” and collectively, the “Purchasers”) and each assignee of a Purchaser who becomes a party hereto.

WHEREAS, subject to the terms and conditions set forth in this Agreement and pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”) and Rule 506 of Regulation D promulgated thereunder, the Company desires to offer, issue and sell to the Purchasers (the “Offering”), and the Purchasers desire to purchase from the Company, up to 600,000 shares (the “Shares”) of the Company’s Common Stock, par value $0.0001 per share (the “Common Stock”). The Shares are sometimes referred to herein as the “Securities”.

WHEREAS, the net proceeds of the Offering are intended to be used by the Company for working capital and other general corporate purposes of the Company and its subsidiaries.

NOW, THEREFORE, in consideration of the mutual covenants and agreements contained in this Agreement, and for other good and valuable consideration the receipt and adequacy of which is hereby acknowledged, the Company and Purchaser agree as follows:

1	SUBSCRIPTION

(a) Subject to the conditions to closing set forth herein, Purchaser hereby irrevocably subscribes for and agrees to purchase Securities for the purchase price indicated on the subscription form (the “Subscription Amount”). The Securities to be issued to Purchaser hereunder shall consist of Shares in an amount equal to, rounded down to the nearest whole number, the quotient of (x) the Subscription Amount, divided by (y) the Share Purchase Price.

(b) For the purposes of this Agreement, the purchase price for each Share shall be $1.50 (the “Share Purchase Price”).

(c) The Company shall use its reasonable best efforts to hold the closing of the Offering (the “Closing”, and the date of the Closing, the “Closing Date”) no later than July 30, 2025. Prior to the Closing, Purchaser shall deliver the Subscription Amount by wire transfer to a bank account in accordance with the wire transfer instructions set forth on Schedule A.

(d) Upon receipt by the Company of the requisite payment for all Securities to be purchased whose subscriptions are accepted, the Company shall, at the Closing: deliver to Purchaser a copy of the irrevocable instructions to the Company’s transfer agent instructing the transfer agent to deliver, on an expedited basis, a book-entry statement evidencing a number of Shares, rounded down to the nearest whole number, equal to such Purchaser’s Subscription Amount divided by the Share Purchase Price, as held in direct registration system advices by the Company’s transfer agent evidencing the electronic registration and ownership by such Purchaser of the Shares to be purchased by such Purchaser and registered in the name of such Purchaser.

(e) Purchaser acknowledges and agrees that (i) the purchase of the Securities by Purchaser pursuant to the Offering is subject to all the terms and conditions set forth in this Agreement, and (ii) this Agreement shall be binding upon Purchaser upon the execution and delivery to the Company of Purchaser’s signed counterpart signature page to this Agreement.

2	DEFINITIONS

In addition to the terms defined elsewhere in this Agreement, the following terms have the meanings set forth in this Section 2:

(a)“Business Day” means any day except any Saturday, any Sunday, any day which is a federal legal holiday in the United States of America or any day on which banking institutions in the State of New York are authorized or required by law or other governmental action to close.

(b)“Exchange Act” means the Securities Exchange Act of 1934, as amended.

(c)“SEC” means the Securities and Exchange Commission.

(d)“SEC Reports” means reports, schedules, forms, statements, and other documents filed or required to be filed by the Company pursuant to Section 13(a) or 15(d) of the Exchange Act.

(e)“Trading Day” means (i) a day on which trading occurs on the OTC Markets, or (ii) if trading does not occur on the OTC Markets, any Business Day.

3	REPRESENTATIONS AND WARRANTIES OF PURCHASER

Purchaser hereby represents and warrants to the Company, and agrees with the Company as follows:

(a) Purchaser understands and acknowledges that (i) the Common Stock is presently only eligible to be quoted on the OTCQB Venture Market tier of the OTC Markets Group, (ii) there can be no assurance as to whether the OTC Markets Group will enable the Common Stock to be quoted on a higher tier market or whether the Common Stock will be traded on a national securities exchange, (iii) even if the Common Stock becomes eligible for quotations or trading on a higher tier of the OTC Markets Group, a national securities exchange, or other trading platform, the amount and volume of such quotations or trading may be limited and subject to higher risk of wider spreads, increased volatility, and price dislocations, and (iv) as a result, Purchaser may be required to hold its shares of Common Stock for an indefinite period of time and may not be able to resell Shares subscribed for by Purchaser at or above the Share Purchase Price, and, notwithstanding the circumstances described in the preceding clauses (i) through (iv), (and without limiting any of the other representations and warranties or agreements of Purchaser herein), Purchaser has made its own investment decision in connection with the Securities issuable pursuant to the Offering.

(b) Purchaser has carefully read this Agreement (the “Offering Document”) and is familiar with and understands the terms provided for hereunder. Purchaser has relied only on the information contained in (i) the Offering Document and (ii) the SEC Reports through the date hereof and has not relied on any representation made by any other person, other than as set forth in Section 4 of this Agreement. Purchaser has carefully considered and has discussed with such Purchaser’s professional legal, tax, accounting, and financial advisors, to the extent deemed necessary, the suitability of an investment in the Securities for Purchaser’s particular tax and financial situation and has determined that the Securities being subscribed for by Purchaser are a suitable investment. PURCHASER UNDERSTANDS AND ACKNOWLEDGES THAT AN INVESTMENT IN THE SECURITIES INVOLVES SUBSTANTIAL RISKS, INCLUDING THE POSSIBLE LOSS OF THE ENTIRE AMOUNT OF SUCH INVESTMENT. Purchaser further understands and acknowledges that the Company has broad discretion concerning the use and application of the proceeds from the Offering.

(c) Purchaser acknowledges that (i) the Company has provided such Purchaser with the opportunity to request copies of any documents, records, and books pertaining to this investment and (ii) any such documents, records and books so requested have been made available for inspection.

(d) Purchaser, and any advisor to such Purchaser, have had a reasonable opportunity to ask questions of and receive answers from representatives of the Company or persons acting on behalf of the Company concerning the Offering and all such questions have been answered to the full satisfaction of Purchaser. Purchaser understands that it is not relying on any communication or representation (written or oral) of any kind made by the Company regarding the Company, the Securities, or any other matter other than as set forth herein.

(e) Purchaser is not subscribing for Securities as a result of or subsequent to any advertisement, article, notice or other communication published in any newspaper, magazine or similar media or broadcast over television or radio or presented at any seminar, meeting or conference whose attendees have been invited by any general solicitation or general advertising.

(f) Purchaser has sufficient knowledge and experience in financial, tax and business matters to enable utilization of the information made available to Purchaser in connection with the Offering, to evaluate the merits and risks of an investment in the Securities and to make an informed investment decision with respect to an investment in the Securities on the terms described in the Offering Document.

(g) Purchaser is an “accredited investor” as defined in Rule 501 of Regulation D under the Securities Act and has delivered to the Company a questionnaire in substantially the form attached hereto as Appendix A (the “Accredited Investor Questionnaire”), which such Purchaser represents, and warrants is true, correct, and complete.

(h) Purchaser will furnish any additional information reasonably requested by the Company to assure compliance with applicable U.S. federal and state securities laws, or upon the request of the Company’s transfer agent, in connection with the purchase and sale of the Securities.

(i) Purchaser will not sell or otherwise transfer the Securities without registration under the Securities Act and applicable state securities laws or an applicable exemption therefrom. Purchaser acknowledges that neither the offer nor sale of the Securities has been registered under the Securities Act or under the securities laws of any state. Purchaser represents and warrants that Purchaser is acquiring the Securities for Purchaser’s own account and not with a current view toward resale or distribution within the meaning of the Securities Act. Purchaser has not offered or sold the Securities being acquired nor does Purchaser have any present intention of selling, distributing or otherwise disposing of such Securities either currently or after the passage of a fixed or determinable period of time or upon the occurrence or non-occurrence of any predetermined event or circumstances in violation of the Securities Act. Purchaser is aware that the Company has no obligation to register the Securities subscribed for hereunder. By making these representations herein, Purchaser is not making any representation or agreement to hold the Securities for any minimum or other specific term and reserves the right to dispose of the Securities at any time in accordance with or pursuant to a registration statement or an available exemption to the registration requirements of the Securities Act.

(j) Purchaser acknowledges that instruments, whether certificated or uncertificated, representing the Shares shall be stamped or otherwise imprinted with a legend substantially in the following form:

THE SECURITIES REPRESENTED HEREBY HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED (THE “SECURITIES ACT”), OR THE SECURITIES LAWS OF ANY STATE OR OTHER JURISDICTION. THE SECURITIES MAY NOT BE OFFERED, SOLD, PLEDGED, OR OTHERWISE TRANSFERRED EXCEPT (1) PURSUANT TO AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT OR (2) PURSUANT TO AN EFFECTIVE REGISTRATION STATEMENT UNDER THE SECURITIES ACT, IN EACH CASE IN ACCORDANCE WITH ALL APPLICABLE STATE SECURITIES LAWS AND THE SECURITIES LAWS OF OTHER JURISDICTIONS, AND IN THE CASE OF A TRANSACTION EXEMPT FROM REGISTRATION, UNLESS THE COMPANY HAS RECEIVED AN OPINION OF LEGAL COUNSEL REASONABLY SATISFACTORY TO IT THAT SUCH TRANSACTION DOES NOT REQUIRE REGISTRATION UNDER THE SECURITIES ACT OR SUCH OTHER APPLICABLE LAWS.

Instruments, whether certificated or uncertificated, representing the Shares shall not be required to contain such legend or any other legend (i) following any sale of such Shares pursuant to Rule 144, or (ii) if such Shares are eligible for sale under Rule 144(b), or (iii) if such legend is not required under applicable requirements of the Securities Act (including judicial interpretations and pronouncements issued by the Staff of the SEC), in each such case (i) through (iii) to the extent reasonably determined by the Company’s legal counsel. Subject to the foregoing, at such time and to the extent a legend is no longer required for the Shares, the Company will use its reasonable best efforts to, no later than the fifth Trading Day following the delivery by Purchaser to the Company or to the Company and the Company’s transfer agent of instructions (and, if previously issued, a legended certificate representing such Shares) together with such accompanying documentation or representations as reasonably required by counsel to the Company, deliver or cause to be delivered an instrument, whether certificated or uncertificated, representing such Shares that is free from the foregoing legend.

(k) Purchaser is a resident of and domiciled in the state and/or country set forth on the signature page hereto.

(l) Purchaser is either, (i) if a natural person, a citizen of and domiciled in the country set forth on the signature page hereto or (ii) if an entity, organized and located in the country set forth on the signature page hereto.

(m) Purchaser is not acquiring the Securities as a nominee or agent or otherwise for any other person.

(n) Purchaser will comply with all applicable laws and regulations in effect in any jurisdiction in which Purchaser purchases or sells the Securities and obtain any consent, approval or permission required for such purchases or sales under the laws and regulations of any jurisdiction to which Purchaser is subject or in which Purchaser makes such purchases or sales, and the Company shall have no responsibility therefor.

(o) If this Agreement is executed and delivered on behalf of a partnership, corporation, limited liability company, trust, estate or other entity: (i) such partnership, corporation, limited liability company, trust, estate or other entity has the full legal right and power and all authority and approval required (a) to execute and deliver this Agreement and all other instruments executed and delivered by or on behalf of such partnership, corporation, limited liability company, trust, estate or other entity in connection with the purchase of its Securities, and (b) to purchase and hold such Securities, (ii) the signature of the party signing on behalf of such partnership, corporation, limited liability company, trust, estate or other entity is binding upon such partnership, corporation, limited liability company, trust, estate or other entity, and (iii) such partnership, corporation, limited liability company, trust or other entity has not been formed for the specific purpose of acquiring such Securities, unless each beneficial owner of such entity is qualified as an accredited investor within the meaning of Rule 501(a) of Regulation D promulgated under the Securities Act.

(p) Purchaser acknowledges that the Company may issue shares of Common Stock, or other or additional securities of the Company, in excess of those being issued in connection with the Offering from time to time. The issuance of additional shares of Common Stock or other securities may cause dilution of the existing shares of Common Stock and a decrease in the market price of such existing shares. Purchaser acknowledges and agrees that it shall have no preemptive rights, right of first refusal, or other rights to subscribe for or purchase any shares of Common Stock the Company may issue in the future as a result of Purchaser’s purchase of Securities pursuant to this Agreement.

(q) Purchaser understands that, unless Purchaser notifies the Company in writing to the contrary at or before the Closing, each of Purchaser’s representations and warranties contained in this Subscription Agreement will be deemed to have been reaffirmed and confirmed as of the Closing Date.

4	REPRESENTATIONS AND WARRANTIES OF THE COMPANY

The Company hereby makes the following representations and warranties to Purchaser:

(a)Organization, Good Standing and Qualification. The Company is a corporation validly existing and in good standing under the laws of the State of Delaware with the exception of its wholly owned and operationally inactive subsidiary, Aldagen, Inc. and, except as disclosed in the SEC Reports, the Company has full corporate power and authority to conduct its business as currently conducted. The Company is qualified to do business as a foreign corporation and is in good standing in all jurisdictions in which the character of the property owned or leased or the nature of the business transacted by it makes qualification necessary, except where the failure to be so qualified would not have a material adverse effect on the business, properties, assets, financial condition or results of operations of the Company and its subsidiaries taken as a whole (a “Material Adverse Effect”).

(b)Capitalization. (i) The authorized capital stock of the Company consists of 100,000,000 shares of Common Stock and 1,000,000 shares of preferred stock, par value $0.0001 per share (“Preferred Stock”), (ii) 46,830,788 shares of Common Stock are issued and outstanding, (iii) 0 shares of preferred stock are issued and outstanding, (iv) 3,334,958 shares of Common Stock are issuable upon the exercise of outstanding stock options under the Company’s 2016 Omnibus Incentive Compensation Plan, as amended (the “Omnibus Plan”), and (v) an aggregate of up to 300,000 shares of Common Stock issuable upon rights subject to the terms and conditions set forth in the Common Stock and Warrant Purchase Agreement dated on and as of August 24, 2022 between the Company and Pacific Medical, Inc. Other than as set forth above, as disclosed in the SEC Reports, or as contemplated in this Agreement, there are no other options, warrants, calls, rights, commitments or agreements of any character to which the Company is a party or by which either the Company is bound or obligating the Company to issue, deliver, sell, repurchase or redeem, or cause to be issued, delivered, sold, repurchased or redeemed, any shares of the capital stock of the Company or obligating the Company to grant, extend or enter into any such option, warrant, call, right, commitment or agreement.

(c)Issuance; Reservation of Shares. The issuance of the Shares has been authorized by all necessary corporate action, and the Shares, when issued and paid for pursuant to this Agreement, will be validly issued, fully paid and non-assessable shares of Common Stock of the Company.

(d)Authorization; Enforceability. The Company has all corporate right, power, and authority to enter into this Agreement, and to consummate the transactions contemplated hereby and thereby. All corporate action on the part of the Company, its directors, and stockholders necessary for the authorization, execution, delivery and performance of this Agreement by the Company, the authorization, sale, issuance, and delivery of the Securities contemplated herein, and the performance of the Company’s obligations hereunder and thereunder has been taken. This Agreement has been duly executed and delivered by the Company and constitutes the legal, valid and binding obligation of the Company, enforceable against the Company in accordance with its terms and subject to laws of general application relating to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws relating to or affecting creditors’ rights generally and rules of law governing specific performance, injunctive relief or other equitable remedies, and to limitations of public policy. The issuance and sale of the Securities contemplated hereby will not give rise to any preemptive rights or rights of first refusal on behalf of any person, except for those that which have been complied with or waived.

(e)No Conflict; Governmental and Other Consents.

(i) The execution and delivery by the Company of this Agreement and the consummation of the transactions contemplated hereby will not result in the violation of, (i) any provision of the Second Amended and Restated Certificate of Incorporation, as amended, or By-Laws of the Company or any of its subsidiaries, or (ii) any law, statute, rule, regulation, order, writ, injunction, judgment or decree of any court or governmental authority to or by which the Company or any of its subsidiaries is bound, and will not conflict with, or result in a breach or violation of, any of the terms or provisions of, or constitute (with due notice or lapse of time or both) a default under, any lease, loan agreement, mortgage, security agreement, trust indenture or other agreement or instrument to which the Company or any of its subsidiaries is a party or by which it is bound or to which any of its properties or assets is subject, nor result in the creation or imposition of any lien upon any of the properties or assets of the Company except to the extent that any such violation, conflict or breach would not be reasonably likely to have a Material Adverse Effect.

(ii) No consent, approval, authorization or other order of any governmental authority or other third party is required to be obtained by the Company in connection with the authorization, execution and delivery of this Agreement or with the authorization, issuance and sale of the Securities, except such post-Closing filings as may be required to be made with the SEC, the Financial Industry Regulatory Authority, Inc., and with any state or foreign blue sky or securities regulatory authority.

(f)Litigation. There are no pending or, to the Company’s knowledge, threatened legal or governmental proceedings against the Company or any of its subsidiaries, which, if adversely determined, would be reasonably likely to have a Material Adverse Effect. There is no action, suit, proceeding, inquiry or investigation before or by any court, public board or body (including, without limitation, the SEC) pending or, to the knowledge of the Company, threatened against or affecting the Company or any of its subsidiaries wherein an unfavorable decision, ruling or finding could adversely affect the validity or enforceability of, or the authority or ability of the Company to perform its obligations under this Agreement. Except as disclosed in the SEC Reports, neither the Company nor any of its subsidiaries are subject to any order, judgment, or decree, which would be reasonably likely to have a Material Adverse Effect.

(g)Investment Company. The Company is not an “investment company” within the meaning of such term under the Investment Company Act of 1940, as amended, and the rules and regulations of the SEC thereunder.

(h)Subsidiaries. Any and all of the Company’s subsidiaries are set forth on Schedule B hereof (collectively referred to herein as the Company’s “subsidiaries”).

(i)Indebtedness. The SEC Reports reflect, as of the date thereof, all outstanding secured and unsecured Indebtedness (as defined below) of the Company or any subsidiary, or for which the Company or any subsidiary has commitments. Neither the Company nor any of its subsidiaries has incurred any material Indebtedness or commitments for Indebtedness since the date of the filing of the most recent SEC Report. For purposes of this Agreement, “Indebtedness” shall mean (a) any liabilities for borrowed money or amounts owed (other than trade accounts payable incurred in the ordinary course of business), (b) all guaranties, endorsements and other contingent obligations in respect of Indebtedness of others, whether or not the same are or should be reflected in the Company’s balance sheet (or the notes thereto), except guaranties by endorsement of negotiable instruments for deposit or collection or similar transactions in the ordinary course of business, and (c) the present value of any lease payments due under leases required to be capitalized in accordance with GAAP. Except as disclosed in the SEC Reports, as of the Closing Date, (i) the Company is not in default with respect to any Indebtedness, and (ii) the Company will not be insolvent after giving effect to the transactions contemplated herein. For purposes of this Section 4(i), “insolvent” shall mean an inability to pay debts when due.

(j)Certain Fees. Except as is set forth on Schedule C, no brokers’, finders’ or financial advisory fees or commissions will be payable by the Company with respect to the transactions contemplated by this Agreement.

(k)Material Agreements. Except as disclosed in the SEC Reports, the Company is not in default under any material agreement now in effect to which the Company is a party, the result of which would be reasonably likely to have a Material Adverse Effect.

(l)Transactions with Affiliates. Except as disclosed in the SEC Reports, there are no loans, leases, agreements, contracts, royalty agreements, management contracts or arrangements or other continuing transactions between (a) the Company, its subsidiaries or any of their respective customers or suppliers on the one hand, and (b) on the other hand, any person who would be covered by Item 404(a) of Regulation S-K or any company or other entity controlled by such person.

(m)Taxes. The Company and its subsidiaries have prepared and filed all federal, state, local, foreign, and other tax returns for income, gross receipts, sales, use and other taxes and custom duties (“Taxes”) required by law to be filed by them, except for tax returns, the failure to file which, individually or in the aggregate, do not and would not have a Material Adverse Effect. Such filed tax returns are complete and accurate, except for such omissions and inaccuracies, which individually or in aggregate, could not reasonably be expected to have a Material Adverse Effect. The Company and its subsidiaries have paid or made provisions for the payment of all Taxes shown to be due on such tax returns and all additional assessments, and adequate provisions have been and are reflected in the financial statements of the Company and the subsidiaries for all current Taxes to which the Company or any subsidiary is subject and which are not currently due and payable, except for such Taxes which, if unpaid, individually or in the aggregate, do not and would not have a Material Adverse Effect. None of the federal income tax returns of the Company or any of its subsidiaries for the past five years has been audited by the Internal Revenue Service. Neither the Company nor any of its subsidiaries has received written notice of any assessments, adjustments, or contingent liability (whether federal, state, local or foreign) in respect of any Taxes pending or threatened against the Company or any subsidiary for any period which, if unpaid, would have a Material Adverse Effect.

(n)Insurance. The Company and its subsidiaries are insured by insurers of recognized financial responsibility against such losses and risks and in such amounts as the Company believes are prudent and customary in the businesses in which the Company and its subsidiaries are engaged. The Company has no reason to believe that it will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its and its subsidiaries’ businesses without an increase in cost significantly greater than general increases in cost experienced for similar companies in similar industries with respect to similar coverage.

(o)Environmental Matters. To the Company’s knowledge, all real property owned, leased or otherwise operated by the Company and its subsidiaries is free of contamination from any substance, waste or material currently identified to be toxic or hazardous pursuant to, within the definition of a substance which is toxic or hazardous under, or which may result in liability under, any Environmental Law (as defined below), including, without limitation, any asbestos, polychlorinated biphenyls, radioactive substance, methane, volatile hydrocarbons, industrial solvents, oil or petroleum or chemical liquids or solids, liquid or gaseous products, or any other material or substance (“Hazardous Substance”) which has caused or would reasonably be expected to cause or constitute a threat to human health or safety, or an environmental hazard in violation of Environmental Law or to result in any environmental liabilities that would be reasonably likely to have a Material Adverse Effect. Neither the Company nor any of its subsidiaries has caused or suffered to occur any release, spill, migration, leakage, discharge, disposal, uncontrolled loss, seepage, or filtration of Hazardous Substances that would reasonably be expected to result in environmental liabilities that would be reasonably likely to have a Material Adverse Effect. The Company and its subsidiaries have generated, treated, stored, and disposed of any Hazardous Substances in compliance with applicable Environmental Laws, except for such non-compliances that would not be reasonably likely to have a Material Adverse Effect. The Company and its subsidiaries have obtained, or has applied for, and is in compliance with and in good standing under all permits required under Environmental Laws (except for such failures that would not be reasonably likely to have a Material Adverse Effect) and neither the Company nor any of its subsidiaries has knowledge of any proceedings to substantially modify or to revoke any such permit. There are no investigations, proceedings or litigation pending or, to the Company’s knowledge, threatened against the Company, its subsidiaries or any of their respective facilities relating to Environmental Laws or Hazardous Substances. For purposes of this Agreement, “Environmental Laws” shall mean all federal, national, state, regional and local laws, statutes, ordinances, and regulations, in each case as amended or supplemented from time to time, and any judicial or administrative interpretation thereof, including orders, consent decrees or judgments relating to the regulation and protection of human health, safety, the environment and natural resources.

(p)Intellectual Property Rights and Licenses. Except as disclosed in the SEC Reports, (a) the Company and its subsidiaries own or have the right to use any and all information, know-how, trade secrets, patents, copyrights, trademarks, trade names, software, formulae, methods, processes and other intangible properties that are of a such nature and significance to the business that the failure to own or have the right to use such items would have a Material Adverse Effect (“Intangible Rights”), (b) neither the Company nor any of its subsidiaries has received any notice that it is in conflict with or infringing upon the asserted intellectual property rights of others in connection with the Intangible Rights, and, to the Company’s knowledge, neither the use of the Intangible Rights nor the operation of the Company’s and its subsidiaries’ businesses is infringing or has infringed upon any intellectual property rights of others in a manner that would be reasonably expected to have a Material Adverse Effect, (c) all payments have been duly made that are necessary to maintain the Intangible Rights in force, (d) no claims have been made, and to the Company’s knowledge, no claims are threatened, that challenge the validity or scope of any material Intangible Right of the Company or any of its subsidiaries, (e) the Company and its subsidiaries have taken reasonable steps to obtain and maintain in force all licenses and other permissions under Intangible Rights of third parties necessary to conduct their businesses as heretofore conducted by them, and now being conducted by them, and as expected to be conducted, and neither the Company nor its subsidiaries is or has been in material breach of any such license or other permission in a manner that would be reasonably expected to have a Material Adverse Effect.

(q)Labor, Employment and Benefit Matters.

(i) There are no existing, or to the Company’s knowledge, threatened strikes or other labor disputes against the Company or any of its subsidiaries that would be reasonably likely to have a Material Adverse Effect. There is no organizing activity involving employees of the Company or its subsidiaries pending or, to the Company’s knowledge, threatened by any labor union or group of employees. There are no representation proceedings pending or, to the Company’s knowledge, threatened with the National Labor Relations Board, and no labor organization or group of employees of the Company or its subsidiaries has made a pending demand for recognition.

(ii) Neither the Company nor any of its subsidiaries is, or during the five years preceding the date of this Agreement was, a party to any labor or collective bargaining agreement and there are no labor or collective bargaining agreements which pertain to employees of the Company or any of its subsidiaries.

(iii) Each employee benefit plan is in compliance with all applicable law, except for such noncompliance that would not be reasonably likely to have a Material Adverse Effect.

(iv) Neither the Company nor any of its subsidiaries have any liabilities, contingent or otherwise, including, without limitation, liabilities for retiree health, retiree life, severance, or retirement benefits, which are not fully reflected, to the extent required by GAAP, on the Company’s financial statements or fully funded. The term “liabilities” used in the preceding sentence shall be calculated in accordance with reasonable actuarial assumptions.

(v) Neither the Company nor any of its subsidiaries has (i) terminated any “employee pension benefit plan” as defined in Section 3(2) of ERISA (as defined below) under circumstances that present a material risk of the Company or any of its subsidiaries incurring any liability or obligation that would be reasonably likely to have a Material Adverse Effect, or (ii) incurred or expects to incur any outstanding liability under Title IV of the Employee Retirement Income Security Act of 1974, as amended and all rules and regulations promulgated thereunder (“ERISA”).

(r)Compliance with Law. Except as disclosed in the SEC Reports, the Company and its subsidiaries are in compliance in all material respects with all applicable laws, including, to the extent applicable, U.S. anti-money laundering laws and U.S. Treasury Department’s Office of Foreign Assets Control regulations, except for such noncompliance that would not reasonably be likely to have a Material Adverse Effect. Neither the Company or its subsidiaries has received any notice of, nor does the Company have any knowledge of, any violation (or of any investigation, inspection, audit or other proceeding by any governmental entity involving allegations of any violation) of any applicable law involving or related to the Company or any of its subsidiaries which has not been dismissed or otherwise disposed of that would be reasonably likely to have a Material Adverse Effect. Neither the Company nor any of its subsidiaries has received notice or otherwise has any knowledge that the Company or any of its subsidiaries is charged with, threatened with or under investigation with respect to, any violation of any applicable law that would reasonably be likely to have a Material Adverse Effect. Neither the Company nor any of its subsidiaries nor, to the Company’s knowledge, any employee or agent of the Company or any subsidiary has made any contribution or other payment to any official of, or candidate for, any federal, state or foreign office in violation of any law. The Company, its subsidiaries and, to the Company’s knowledge, their respective directors, officers, employees, and agents have complied in all material respects with the Foreign Corrupt Practices Act of 1977, as amended, and any related rules and regulations.

(s)Ownership of Property. Except as disclosed in the SEC Reports, the Company and its subsidiaries has (i) good and marketable fee simple title to its owned real property, if any, free and clear of all liens, except for liens which do not individually or in the aggregate have a Material Adverse Effect, (ii) a valid leasehold interest in all leased real property, and each of such leases is valid and enforceable in accordance with its terms (subject to laws of general application relating to bankruptcy, insolvency, fraudulent transfer, reorganization, moratorium and similar laws relating to or affecting creditors’ rights generally and rules of law governing specific performance, injunctive relief or other equitable remedies, and to limitations of public policy) and is in full force and effect, and (iii) good title to, or valid leasehold interests in, all of its other properties and assets free and clear of all liens, except for liens which do not individually or in the aggregate have a Material Adverse Effect.

(t)No Integrated Offering. Assuming the accuracy of Purchaser’s representations and warranties set forth in Section 3 of this Agreement, neither the Company, nor any of its affiliates or other person acting on the Company’s behalf has, directly or indirectly, made any offers or sales of any security or solicited any offers to buy any security under circumstances that would cause the Offering of the Securities to be integrated with prior offerings by the Company for purposes of the Securities Act, when integration would cause the Offering not to be exempt from the requirements of Section 5 of the Securities Act.

(u)General Solicitation. Neither the Company nor, to its knowledge, any person acting on behalf of the Company, has offered, or sold any of the Securities by any form of “general solicitation” within the meaning of Rule 502 under the Securities Act.

(v)No Manipulation of Stock. The Company has not taken and will not take, in violation of applicable law, any action designed to or that might reasonably be expected to cause or result in stabilization or manipulation of the price of the Common Stock to facilitate the sale or resale of the Securities.

(w)No Registration. Assuming the accuracy of the representations and warranties made by, and compliance with the covenants of, Purchaser, no registration of the Securities under the Securities Act is required in connection with the offer and sale of the Securities by the Company to Purchaser as contemplated by this Agreement.

(x)Disclosure. The Company understands and acknowledges that Purchaser will rely on the foregoing representations in purchasing the Securities of the Company hereunder. To the Company’s knowledge, as of and since the date of filing of the Company’s Annual Report on 10-K for the fiscal year ended December 31, 2024, all disclosure made available by the Company to Purchaser in the Company’s SEC Reports regarding the Company, its business and the transactions contemplated hereby furnished by or on the behalf of the Company are, taken as a whole, true and correct in all material respects and do not contain any untrue statement of a material fact or omit to state any material fact necessary in order to make the statements made therein, in the light of the circumstances under which they were made, not misleading. To the Company’s knowledge, as of and since the date of filing of the Company’s Annual Report on 10-K for the fiscal year ended December 31, 2024, no material event or circumstance has occurred or information exists with respect to the Company or its business, properties, operations or financial conditions, which, under applicable law, rule or regulation, requires public disclosure or announcement by the Company but which has not been so publicly announced or disclosed.

5	UNDERSTANDINGS

Purchaser understands, acknowledges, and agrees with the Company as follows:

(a) The execution of this Agreement by Purchaser or solicitation of the investment contemplated hereby shall create no obligation on the part of the Company to accept any subscription or complete the Offering. If the Company accepts the subscription for Securities made by Purchaser, it shall countersign this Agreement. Purchaser hereby acknowledges and agrees that the subscription hereunder, once accepted by the Company, is irrevocable by Purchaser, and that, except as required by law, Purchaser is not entitled to cancel, terminate, or revoke this Agreement or any agreements of Purchaser hereunder.

(b) No federal or state agency or authority has made any finding or determination as to the accuracy or adequacy of the Offering Document or as to the fairness of the terms of the Offering nor any recommendation or endorsement of the Securities. Any representation to the contrary is a criminal offense. In making an investment decision, Purchaser must rely on such Purchasers’ own examination of the Company and the terms of the Offering, including the merits and risks involved.

(c) The Offering is intended to be exempt from registration under the Securities Act by virtue of Section 4(a)(2) of the Securities Act and the provisions of Rule 506 of Regulation D thereunder, which is in part dependent upon the truth, completeness and accuracy of the statements made by Purchaser herein.

(d) Notwithstanding the registration obligations provided herein, there can be no assurance that Purchaser will be able to sell or dispose of the Securities. It is understood that in order not to jeopardize the Offering’s exempt status under Section 4(a)(2) of the Securities Act and Regulation D, any transferee may, at a minimum, be required to fulfill the investor suitability requirements thereunder.

(e) Purchaser acknowledges that the Offering is confidential and non-public and agrees that all information about the Offering shall be kept in confidence by Purchaser until the public announcement of the Offering by the Company. Purchaser acknowledges that the foregoing restrictions on Purchaser’s use and disclosure of any such confidential, non-public information contained in the above-described documents restricts Purchaser from trading in the Company’s securities to the extent such trading is on the basis of material, non-public information of which Purchaser is aware. Except for the terms of the transaction documents and the fact that the Company is considering consummating the transactions contemplated therein (which information the Company has agreed to disclose in accordance with this Agreement), the Company confirms that neither the Company nor, to its knowledge, any other person acting on its behalf, has provided Purchaser or such Purchaser’s agents or counsel with any information that constitutes material, non-public information as of the Closing Date.

6	COVENANTS OF THE COMPANY

(a) The Company shall make a public announcement of the execution of this Agreement and the terms of the transaction documents by issuing a press release or, as necessary, filing with the SEC a Current Report on Form 8-K or Quarterly Report on Form 10-Q not later than 5:30 p.m. New York City time on the fourth Business Day following the date of this Agreement.

(b) The Company shall use its reasonable best efforts to file in a timely manner all required reports under the Exchange Act.

(c) The Company agrees to file one or more Forms D with respect to the Securities on a timely basis as required under Regulation D under the Securities Act to claim the exemption provided by Rule 506 of Regulation D.

(d) The Company will not sell, offer to sell, solicit offers to buy or otherwise negotiate in respect of any “security” (as defined in the Securities Act) that is or could be integrated with the sale of the Securities in a manner that would require the registration of the Securities under the Securities Act.

(e) The Company intends that the net proceeds from the Offering will be used for working capital and other general corporate purposes of the Company.

7	MISCELLANEOUS

(a)Notices. All notices, requests, consents, claims, waivers and other communications hereunder (each, a “Notice”) shall be in writing and delivered by personal delivery, nationally recognized overnight courier (with all fees pre-paid), facsimile or e-mail of a PDF document (with confirmation of transmission), or certified or registered mail (in each case, return receipt requested, postage prepaid). Except as otherwise provided in this Agreement, a Notice is effective only (x) upon receipt by the receiving party, (y) if the party giving the Notice has complied with the requirements of this Section 7(a), and (z) upon delivery,

(i) if to the Company, at

Nuo Therapeutics, Inc.

8285 El Rio, Suite 190

Houston, TX 77054

Attention: Chief Executive Officer

Phone: (346) 396-4770

email: djorden@nuot.com

or such other address as it shall have specified to Purchaser in writing.

(ii) if to Purchaser, at its physical or email address set forth on the signature page to this Agreement, or such other address as it shall have specified to the Company in writing.

(b)Section Headings. The section headings in this Agreement are for reference purposes only and shall not affect the meaning or interpretation of this Agreement. References in this Agreement to a designated “Section” refer to a Section of this Agreement unless otherwise specifically indicated.

(c)Governing Law. This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware.

(d)Consent to Jurisdiction and Service of Process. The parties to this Agreement hereby agree to submit to the exclusive jurisdiction of the courts of the State of Delaware and the courts of the United States of America located in the District of Delaware, and appellate courts from any thereof in any action or proceeding arising out of or relating to this Agreement. Service of process, summons, notice or other document by mail to such party's address set forth herein shall be effective service of process for any suit, action or other proceeding brought in any such court.

(e)Waiver of Jury Trial. Each of the parties to this Agreement hereby unconditionally agrees to waive, to the fullest extent permitted by applicable law, its respective rights to a jury trial of any claim or cause of action (whether based on contract, tort or otherwise) based upon, arising out of or relating to this Agreement or the transactions contemplated hereby. The scope of this waiver is intended to be all-encompassing of any and all disputes that may be filed in any court and that relate to the subject matter of this Agreement, including contract claims, tort claims and all other common law and statutory claims. Each party hereto: (i) acknowledges that this waiver is a material inducement to enter into this Agreement, that each has already relied on this waiver in entering into this Agreement, and that each will continue to rely on this waiver in their related future dealings, (ii) acknowledges that no representative, agent or attorney of any other party has represented, expressly or otherwise, that such other party would not in the event of any action or proceeding, seek to enforce the foregoing waiver and (iii) warrants and represents that it has reviewed this waiver with its legal counsel and that it knowingly and voluntarily waives its jury trial rights following consultation with legal counsel. THIS WAIVER IS IRREVOCABLE, MEANING THAT IT MAY NOT BE MODIFIED EITHER ORALLY OR IN WRITING (OTHER THAN BY A MUTUAL WRITTEN WAIVER SPECIFICALLY REFERRING TO THIS SECTION 7(E) AND EXECUTED BY EACH OF THE PARTIES HERETO), AND THIS WAIVER SHALL APPLY TO ANY SUBSEQUENT AMENDMENTS, RENEWALS, SUPPLEMENTS OR MODIFICATIONS TO THIS AGREEMENT.

(f)Amendment. Neither this Agreement nor any provisions hereof shall be amended, waived, modified, changed, discharged, or terminated except by an instrument in writing executed by the Company and Purchaser. Except as otherwise set forth in this Agreement, no failure to exercise, or delay in exercising, any rights, remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof; nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.

(g)Entire Agreement. This Agreement constitutes the sole and entire agreement and understanding of the parties with respect to the transactions contemplated hereby and thereby, and supersedes all prior and contemporaneous understandings, agreements, representations, and warranties, both written and oral, with respect to such transactions.

(h)Severability. The invalidity or unenforceability of any specific provision of this Agreement shall not invalidate or render unenforceable any of its other provisions. Any provision of this Agreement held invalid or unenforceable shall be deemed reformed, if practicable, to the extent necessary to render it valid and enforceable and to the extent permitted by law and consistent with the intent of the parties to this Agreement.

(i)Survivability. All representations, warranties and covenants contained in this Agreement shall survive (x) the acceptance of the subscription by the Company and the Closing, and (y) the death or disability of Purchaser.

(j)Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the parties and their successors and permitted assigns. The Company may not assign (other than by merger) this Agreement or any rights or obligations hereunder without the prior written consent of a majority of the Purchasers. Purchaser may assign any or all of its rights under this Agreement to any person to whom such Purchaser assigns or transfers any Securities, provided that such transferee agrees in writing to be bound, with respect to the transferred Securities, by the provisions of this Agreement.

(k)No Third-Party Beneficiaries. This Agreement is intended for the benefit of the parties hereto and their respective successors and permitted assigns and is not for the benefit of, nor may any provision hereof be enforced by, any other person, except as set forth herein.

(l)Fees and Expenses. Each party shall pay the fees and expenses of its counsel, advisors, accountants and other experts, if any, and all other expenses incurred by such party incident to the negotiation, preparation, execution, delivery and performance of this Agreement. The Company shall pay all of the Company’s transfer agent fees in connection with the Closing.

(m)Arms Length Negotiations. The Company acknowledges and Purchaser confirms that it has independently participated in the negotiation of the transaction contemplated hereby with the advice of its own counsel and advisors.

(n)Counterparts. This Agreement may be executed in multiple counterparts, each of which shall be deemed an original, but all of which together shall constitute the same instrument. A signed copy of this Agreement delivered by facsimile, email or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

(SUBSCRIPTION SIGNATURE PAGE FOLLOWS)

Purchaser hereby subscribes for such number of Shares as shall equal the Subscription Amount as set forth below divided by the Share Purchase Price, rounded down to the nearest whole number, and agrees to be bound by the terms and conditions of this Agreement.

PURCHASER

Dated:
Number of Shares:
Subscription Amount:	$
Name (please print as name will appear on stock certificate or book-entry record):
Signature of Purchaser:
Name and Title of Officer (if applicable)
Number and Street:
City:
State:
Zip Code (or other postal code):
Country:
Email:
Social Security Number, or Taxpayer Identification Number (if applicable):
Signature of Joint Purchaser (if any):
Social Security Number of Joint Purchaser (if any):
	ACCEPTED BY:
	NUO THERAPEUTICS, INC.
	By:<br><br> <br>Name: David Jorden<br><br> <br>Title: CEO<br><br> <br>Dated: July 30, 2025

APPENDIX A

ACCREDITED INVESTOR QUESTIONNAIRE

In order for the Company to offer and sell the Securities in conformance with state and federal securities laws, the following information must be obtained regarding your investor status. Please initial each category applicable to you as Purchaser*.*

___ (1) A natural person whose individual net worth, or joint net worth with that person’s spouse, at the time of purchase exceeds $1,000,000 (for purposes of calculating net worth, (i) that person’s primary residence is not to be included as an asset, (ii) indebtedness secured by that person’s primary residence — up to the estimated fair market value of the primary residence at the time of the sale of Securities — is not to be included as a liability, and (iii) indebtedness that is secured by that person’s primary residence in excess of the estimated fair market value of that person’s primary residence at the time of the sale of Securities is to be included as a liability);

___ (2) A natural person who had an individual income in excess of $200,000 in each of the two most recent years, or joint income with that person’s spouse in excess of $300,000, in each of those years, and has a reasonable expectation of reaching the same income level in the current year;

___ (3) An executive officer or director of the Company;

___ (4) A holder of one of the following licenses in good standing: General Securities Representative license (Series 7), the Private Securities Offerings Representative license (Series 82), or the Investment Adviser Representative license (Series 65);

___ (5) A trust, with total assets in excess of $5,000,000, not formed for the specific purpose of acquiring the Securities, whose purchase is directed by a sophisticated person who has such knowledge and experience in financial and business matters that such person is capable of evaluating the merits and risks of investing in the Company;

___ (6) A limited liability company, not formed for the specific purpose of acquiring the Securities, with total assets in excess of $5,000,000;

___ (7) A partnership, not formed for the specific purpose of acquiring the Securities, with total assets in excess of $5,000,000;

___ (8) A corporation, not formed for the specific purpose of acquiring the Securities, with total assets in excess of $5,000,000;

___ (9) A Massachusetts or similar business trust, not formed for the specific purpose of acquiring the Securities, with total assets in excess of $5,000,000;

___ (10) An organization described in Section 501(c)(3) of the Internal Revenue Code, not formed for the specific purpose of acquiring the Securities, with total assets in excess of $5,000,000;

___ (11) A bank as defined in Section 3(a)(2) of the Securities Act, or any savings and loan association or other institution as defined in Section 3(a)(5)(A) of the Securities Act whether acting in its individual or fiduciary capacity;

___ (12) A broker or dealer registered pursuant to Section 15 of the Exchange Act;

___ (13) An investment adviser registered pursuant to Section 203 of the Investment Advisers Act of 1940 or registered pursuant to the laws of a state;

___ (14) An investment adviser relying on the exemption from registering with the SEC under Section 203(l) or (m) of the Investment Advisers Act of 1940;

___ (15) An insurance company as defined in Section 2(a)(13) of the Securities Act;

___ (16) An investment company registered under the Investment Company Act of 1940 or a business development company as defined in Section 2(a)(48) of that act;

___ (17) A Small Business Investment Company licensed by the U.S. Small Business Administration under Section 301(c) or (d) of the Small Business Investment Act of 1958;

___ (18) A Rural Business Investment Company as defined in Section 384A of the Consolidated Farm and Rural Development Act;

___ (19) A plan established and maintained by a state, its political subdivisions, or any agency or instrumentality of a state or its political subdivisions, for the benefit of its employees, if such plan has total assets in excess of $5,000,000;

___ (20) An employee benefit plan within the meaning of the Employee Retirement Income Security Act of 1974, if the investment decision is made by a plan fiduciary, as defined in Section 3(21) of such act, which is either a bank, savings and loan association, insurance company or registered investment adviser, or if the employee benefit plan has total assets in excess of $5,000,000 or, if a self-directed plan, with investment decisions made solely by persons that are accredited investors;

___ (21) A private business development company as defined in Section 202(a)(22) of the Investment Advisers Act of 1940;

___ (22) An entity in which all of the equity owners qualify under any of the subparagraphs in this Accredited Investor Questionnaire (list the accredited investor category which each such equity owner satisfies: );

___ (23) An entity (of a type not listed above), not formed for the specific purpose of acquiring the Securities, with total assets in excess of $5,000,000;

___ (24) A “family office,” as defined in Rule 202(a)(11)(G)-1 under the Investment Advisers Act of 1940, (i) with assets under management in excess of $5,000,000, (ii) that is not formed for the specific purpose of acquiring the Securities, and (iii) whose prospective investment is directed by a person who has such knowledge and experience in financial and business matters that such family office is capable of evaluating the merits and risks of the prospective investment;

___ (25) A “family client,” as defined in Rule 202(a)(11)(G)-1 under the Investment Advisers Act of 1940, of a family office meeting the requirements in subparagraph (24) above and whose prospective investment in the issuer is directed by such family office pursuant to subparagraph (24)(iii) above.

SCHEDULE A

WIRE TRANSFER INFORMATION

Branch Name:	Houston
Bank Name:	Chase Bank
Bank Address:	7007 Fannin St.
	Houston, TX 77030
Swift Code:	XXXXXXXX
Routing Number:	XXXXXXXXX For ACH
Routing Number:	XXXXXXXXX For Wires
Account Number:	XXXXXXXXX

SCHEDULE B

SUBSIDIARIES

Aldagen, Inc. (Delaware)

SCHEDULE C

CERTAIN FEES AND COMMISSIONS

None.

ex_838274.htm

Exhibit 31

Certification of Principal Executive and Principal Financial Officer Pursuant to Exchange Act Rule

13a-14(a)/15d-14(a) as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

I, David E. Jorden, certify that:

1.	I have reviewed this Quarterly Report on Form 10-Q of Nuo Therapeutics, Inc.;
2.	Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
---	---
3.	Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
---	---
4.	I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
---	---
(a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
---	---
(b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
---	---
(c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
---	---
(d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
---	---
5.	I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
---	---
(a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
---	---
(b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
---	---

Date: July 31, 2025

/s/ David E. Jorden

David E. Jorden

Chief Executive and Financial Officer

(Principal Executive Officer and Principal Financial Officer)

ex_838275.htm

Exhibit 32

Certification of Principal Executive 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

Pursuant to 18 U.S.C. §1350 and in connection with the Quarterly Report on Form 10-Q of Nuo Therapeutics, Inc. (the “Company”) for the period ended June 30, 2025 (the “Report”), I, David E. Jorden, Chief Executive and Financial Officer of the Company, hereby certify that to my knowledge:

1.	The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
2.	The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
---	---

Date: July 31, 2025

/s/ David E. Jorden

David E. Jorden

Chief Executive and Financial Officer

(Principal Executive Officer and Principal Financial Officer)

This certification is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Company under the Securities Act of 1933 or the Securities Act of 1934 (whether made before or after the date of the Report), irrespective of any general incorporation language contained in such filing.