Nuo Therapeutics, Inc.

Previous wording

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.

Current wording

Our only significant current commercial offering consists of a point of care technology for the separation of autologous blood to produce a platelet-based therapy for use in the chronic wound care market. This offering is known as “Aurix” or the “Aurix System”. The FDA cleared the Aurix System for marketing in 2007 as a device under Section 510(k) of the Federal Food, Drug, and Cosmetic Act (“FDCA”). Aurix is one of three platelet derived products cleared by the FDA for chronic wound care use and can be used for most exuding wounds. The advanced wound care market, within which Aurix competes, is composed of advanced wound care dressings, wound care devices, and wound care biologics, and was estimated to be an approximately $10.8 billion global market in 2021 with the North American market estimated at approximately $4.15 billion in 2020. Estimates remain that 1-2% of the population in the developed countries will suffer from a chronic wound at least once in their lifetime. According to the National Institute of Health, treatment of diabetic foot ulcers cost an estimated $9-$13 billion annually in the U.S. alone. An aging population and the still increasing prevalence of diabetes suggests a continued increase in the patient population at risk of developing chronic, non-healing wounds.

Previous wording

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.

Current wording

In 2012, a Medicare National Coverage Determination (“NCD”) from CMS reversed a twenty-year old non-coverage decision for autologous blood derived products used in wound care. This NCD allowed for Medicare coverage under the Coverage with Evidence Development (“CED”) program. CED programs have been selected for a variety of other therapies, including transcatheter aortic valve repair and cochlear implantation. Under a CED program, CMS provides reimbursement for items or services on the condition that they be furnished in approved clinical protocols or in the collection of additional clinical data. Due to the CED program, a facility treating a patient with Aurix was reimbursed by Medicare when health outcomes data were collected to inform future coverage decisions. The intent of the CED program was to evaluate the outcomes of Aurix therapy for the broader Medicare population when it is used in a “real world” continuum of care.

Previous wording

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").

Current wording

In April 2021, CMS issued a final coverage decision memo indicating that Medicare would nationally cover autologous PRP for the treatment of chronic non-healing diabetic wounds for individual patients' care for a duration of 20 weeks under Section 1862(a)(1)(A) of the Social Security Act. This coverage applies when using devices whose FDA-cleared indications include the management of exuding cutaneous wounds, such as diabetic ulcers. Coverage of autologous PRP beyond 20 weeks for diabetic foot ulcers and for the treatment of all other chronic, non-diabetic, non-healing wounds is determined by local Medicare Administrative Contractors ("MACs").

Previous wording

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.

Current wording

Although the FDA cleared the Aurix System for marketing for wound care management in 2007 under Section 510(k) of the FDCA, economically viable reimbursement in the commercial market for the product only became viable with CMS's issuance of the NCD in 2021. For 2026, the CMS national average reimbursement rate for the Aurix System is $2,108 per treatment in place of service ("POS") 22 (hospital outpatient departments), which we believe provides appropriate payment to facilities for product usage. We submitted public comments to CMS as part of its annual rule-making procedures under the Physician Fee Schedule ("PFS") for payments to clinicians in primarily POS 11 (physician offices) in both 2023 and 2024. In November 2024, CMS issued its final PFS for calendar 2025 and established a national average payment of $890. In response to this final rule which removed the payment amount discretion from the MACs within POS 11, the Aurix System became economically viable within the physician office care setting effective January 1, 2025. For 2026, the CMS national average reimbursement rate for the Aurix System is $1,064 per treatment in POS 11 (private offices).

Previous wording

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.

Current wording

Our current commercial focus is to continue engaging and establishing relationships with providers treating chronic non-healing wounds to demonstrate the clinical benefits we believe result from the use of Aurix in the treatment of complex wounds. Increasing physician awareness of the differentiating attributes of Aurix will be key to establishing a base of product revenues upon which to grow. We anticipate developing these relationships with clinical providers and treatment facilities primarily by establishing a variety of distributor and sales agent arrangements throughout the United States and internationally. Our commercial team consists of three senior employees who are leveraging their current and historical relationships to establish additional third-party sales arrangements.

Previous wording

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.

Current wording

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

Previous wording

As of September 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.

Current wording

As of March 31, 2026, we had established contractual relationships with more than 200 third-party entity and individual representatives. The number of sales agent representatives may continue to expand modestly in the months ahead, but the current focus is broadening commercial customer relationships with wound care providers operating in private office settings while continuing to engage with hospitals and hospital systems regarding expanded POS 22 usage while ensuring that the reimbursement mechanisms are appropriately administered by the local Medicare Administrative Contractors in support of the April 2021 NCD.

Previous wording

On March 31, 2025, we entered into a Distribution Agreement (the “Distribution Agreement”) with a U.S. affiliate of Smith & Nephew PLC (“Smith+Nephew”), a global medical technology company. Under the Distribution Agreement, we will supply Smith+Nephew 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.

Current wording

On March 31, 2025, we entered into a Distribution Agreement (the “Distribution Agreement”) with a U.S. affiliate of Smith & Nephew PLC (“Smith+Nephew”), a global medical technology company. Under the Distribution Agreement, we supply to Smith+Nephew its own private label of our Aurix product. Although Smith+Nephew will be the sole and exclusive distributor in the United States of a private label Aurix product (the “Private Label product”), we have the ability and will continue to market, distribute, and sell our own Aurix branded product.

Previous wording

Under the Distribution Agreement, Smith+Nephew will purchase Private Label product from us from time to time at agreed upon transfer pricing and we shall manufacture, package, and ship the Private Label product to Smith+Nephew’s customers in accordance with purchase orders and the Distribution Agreement. During the initial term of the Distribution Agreement commencing on the date of first sale by Smith+Nephew, minimum annual purchase commitments will apply to Smith+Nephew of an average of approximately $500,000 per year for Smith+Nephew to maintain exclusive distribution rights.

Current wording

Under the Distribution Agreement, Smith+Nephew will purchase Private Label product from us from time to time at agreed upon transfer pricing and we shall manufacture, package, and ship the Private Label product to Smith+Nephew’s customers in accordance with purchase orders and the Distribution Agreement. During the initial term of the Distribution Agreement commencing on the date of first commercial sales in October 2025, minimum annual purchase commitments will apply to Smith+Nephew of an average of approximately $500,000 per year for Smith+Nephew to maintain exclusive distribution rights.

Previous wording

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

Current wording

Effective January 1, 2026, we entered into an amendment to the agreement to add certain expansion kits in connection with the Private Label product for which we received an upfront fee of $50,000. As consideration for entering into the Distribution Agreement, Smith+Nephew paid us an upfront distribution fee of $1,500,000 for distribution rights and we are also eligible to be paid by Smith+Nephew an additional $750,000 in fees based on our establishment and maintenance of reimbursement in certain categories for the Aurix and the Private Label products. These fees will be refundable to Smith+Nephew on a pro rata basis for the unexpired initial term of the Distribution Agreement if we do not comply with certain terms and conditions.

Previous wording

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

Current wording

The amounts presented in this comparison section are rounded to the nearest thousand.

Previous wording

Total revenues for the three months ended September 30, 2025 totaled approximately $1,032,000 including $75,000 of license fee revenue related to the Smith+Nephew distribution agreement. Product revenues for the three months ended September 30, 2025 totaled approximately $957,000 in comparison to product and total revenues of approximately $371,000 in the three months ended September 30, 2024 representing an increase of approximately $661,000. Product revenues associated with the Smith+Nephew private label distribution arrangement were recognized for the first time in the three months ended September 30, 2025 consisting solely of centrifuge devices sold to Smith+Nephew in anticipation of their product launch. Associated gross profit was approximately $625,000 in the three months ended September 30, 2025 in comparison to approximately $270,000 of gross profit in the three months ended September 30, 2024. The increase in revenues was due primarily to (i) increased Aurix product revenues resulting from an expanding customer base over the past year, (ii) the initial Smith+Nephew product revenues for centrifuge devices discussed above and (iii) license fee revenue under the distribution agreement. Aggregate gross margin was approximately 61% in the quarter as compared to approximately 73% in the prior year’s quarter. The gross margin decline was primarily due to the centrifuge devices sold to Smith+Nephew at a near zero gross margin on the negotiated transfer price of the devices including the impact of tariff surcharges from the device manufacturer which was partially offset by the license fee revenues having no associated cost.

Current wording

The increase in revenues was due primarily to (i) increased Aurix product revenues resulting from an expanding customer base over the past year, (ii) Smith+Nephew related product revenues for centrifuge devices and kits solely and (iii) distribution fee revenue recognized under the distribution agreement as amended. Aggregate gross margin was approximately 65% for the three months ended March 31, 2026 as compared to approximately 75% for the three months ended March 31, 2025. The gross margin decline was primarily due to the centrifuge devices sold to Smith+Nephew at a near zero gross margin on the negotiated transfer price of the devices which was partially offset by distribution fee revenue having no associated cost.

Previous wording

Total operating expenses increased approximately $884,000 to approximately $3,467,000 comparing the nine months ended September 30, 2025 to the nine months ended September 30, 2024. The increase from the prior year was due primarily to increases in (i) professional fees of approximately $374,000 due largely to the combination of increased legal fees associated with the negotiation and finalization of the Smith+Nephew distribution agreement and SEC registration statements filed in the nine-month period and consulting expenses for our quality management system and reimbursement support services and legal (ii) third party commission expense of approximately $221,000 for independent sales representatives and distributors resulting from increased Aurix product revenues, and (iii) compensation and benefit costs of approximately $154,000 attributable primarily to added sales management personnel.

Current wording

Total operating expenses increased approximately $188,000 to approximately $1,296,000 comparing the three months ended March 31, 2026 to the three months ended March 31, 2025. The increase from the prior year was due primarily to increases in (i) compensation and benefit costs of approximately $110,000 and (ii) third party commission expense of approximately $158,000 for independent sales representatives and distributors resulting from increased Aurix product revenues which was partially offset by a decrease in professional fees of approximately $74,000 as the costs associated with the finalization of the Smith+Nephew distribution agreement were absent in the current year period.

Previous wording

As of September 30, 2025, we had cash balances of approximately $0.5 million, total current assets of approximately $1.5 million and total current liabilities of approximately $1.3 million. As an operational business, we have a history of losses and are not currently profitable. For the years ended December 31, 2024, and 2023, we incurred net losses of approximately $2.3 million and $3.2 million, respectively. As of September 30, 2025, our accumulated deficit was approximately $34.2 million, and our stockholders’ deficit was approximately $0.4 million.

Current wording

As of March 31, 2026, we had cash balances of approximately $0.3 million, total current assets of approximately $1.5 million and total current liabilities of approximately $1.4 million. As an operational business, we have a history of losses and are not currently profitable. For the years ended December 31, 2025, and 2024, we incurred net losses of approximately $2.5 million and $2.3 million, respectively. As of March 31, 2026, our accumulated deficit was approximately $35.4 million and our stockholders’ deficit was approximately $1.4 million.

Previous wording

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.

Current wording

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

Previous wording

Cash used in operating activities for the nine months ended September 30, 2025 of approximately $442,000 primarily reflects our net loss of approximately $1,934,000 adjusted by (i) the $1,350,000 increase in deferred revenues and (ii) approximately $177,000 in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation. The deferred revenue is due to the receipt of the $1.5 million upfront distribution fee from Smith+Nephew in conjunction with the private label distribution agreement which was effective as of March 31, 2025.

Current wording

Cash provided by operating activities for the three months ended March 31, 2025 of approximately $2,000 primarily reflects our net loss of approximately $746,000 adjusted by (i) approximately $474,000 net change in operating assets and liabilities (excluding deferred revenue), (ii) approximately $52,000 in total for amortization of right of use assets, depreciation of property and equipment, and stock-based compensation, and (iii) $200,000 increase in deferred revenue. The deferred revenue is due to the receipt in February 2025 of a $200,000 exclusivity payment from Smith+Nephew in conjunction with the private label distribution agreement which was executed as of March 31, 2025.

Previous wording

Cash used in investing activities for the nine months ended September 30, 2025 and 2024 primarily represents approximately $220,000 and $150,000 in expenditures, respectively, for the purchase of Aurix centrifuge devices.

Current wording

Cash used in investing activities for the three months ended March 31, 2026 was nominal while cash used in investing activities for the three months ended March 31, 2025 primarily represents $220,000 in expenditures for the purchase of centrifuge devices.

Previous wording

Our unaudited consolidated financial statements included in Part I, Item 1 of this Quarterly Report are prepared in conformity with U.S. GAAP, which require us to make estimates and assumptions regarding future events that affect the amounts reported in our financial statements and accompanying notes. We base these estimates on our experience and assumptions regarding future events we believe to be reasonable under the circumstances. Actual results could differ from those estimates and such differences may be material to the unaudited consolidated financial statements. Consistent with the disclosure in our Annual Report for the year December 31, 2024, there are no accounting policies identified as critical.

Current wording

Our unaudited consolidated financial statements included in Part I, Item 1 of this Quarterly Report are prepared in conformity with U.S. GAAP, which require us to make estimates and assumptions regarding future events that affect the amounts reported in our financial statements and accompanying notes. We base these estimates on our experience and assumptions regarding future events we believe to be reasonable under the circumstances. Actual results could differ from those estimates and such differences may be material to the unaudited consolidated financial statements. 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 and no significant estimation since December 31, 2025.