AURX

Except as may be required by applicable law, 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.
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.
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.
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 CED program, a facility treating a patient with Aurix was reimbursed by Medicare when health outcomes data were collected to inform future coverage decisions.
Coverage of autologous PRP beyond 20 weeks for diabetic foot ulcers and for the treatment of all other chronic, non-diabetic, non-healing wounds is determined by local Medicare Administrative Contractors ("MACs").
Although the FDA cleared the Aurix System for marketing for wound care management in 2007 under Section 510(k) of the FDCA, economically viable reimbursement in the commercial market for the product only became viable with CMS's issuance of the NCD in 2021.
For 2026, the CMS national average reimbursement rate for the Aurix System is $2,108 per treatment in place of service ("POS") 22 (hospital outpatient departments), which we believe provides appropriate payment to facilities for product usage.
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.
For 2026, the CMS national average reimbursement rate for the Aurix System is $1,064 per treatment in POS 11 (private offices).
Our commercial team consists of four senior employees who are leveraging their current and historical relationships to establish additional third-party sales arrangements.
Following the restart of our business activities in October 2021, commercially available Aurix product first became available in May 2022 for demonstration and evaluation purposes.
While limited initial commercial revenues were recorded during the second half of 2022, product adoption has consistently increased with product revenues of approximately $1.4 million in 2024 increasing to approximately $3.1 million in 2025, and we expect revenues will continue growing in the future.
As of December 31, 2025, 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.
Under the Distribution Agreement, we supply to Smith+Nephew its own private label of our Aurix product.
During the initial term of the Distribution Agreement commencing on the date of first commercial sales in October 2025, minimum annual purchase commitments will apply to Smith+Nephew of an average of approximately $500,000 per year for Smith+Nephew to maintain exclusive distribution rights.
As consideration for entering into the Distribution Agreement, Smith+Nephew paid us an upfront distribution fee of $1,500,000 for distribution rights 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.
Ostomy Wound Management , 2012; 58(4):36-49.) Customer Concentration Our revenues are derived from the sale of the Aurix product to customers consisting primarily of hospital outpatient wound care clinics and private practice physicians treating chronic wounds and sales of the Private Label products to Smith+Nephew.
Total product revenues increased to approximately $3.1 million for the year ended December 31, 2025 versus approximately $1.4 million for the year ended December 31, 2024 while total 2025 revenues were approximately $3.3 million including the distribution fee revenues recognized under the Distribution Agreement.
Employees The Company had 10 full-time employees as of December 31, 2025 which are all compensated as salaried employees.
Research and Development During the years ended December 31, 2025 and 2024, we incurred no significant costs for research and development activities.
As described above, Smith+Nephew is the exclusive distributor of a Private Label product of Aurix.
Smith+Nephew’s Private Label Product directly competes with Aurix.
Leading companies in the advanced wound care market also include 3M, MoInlycke, and ConvaTec.
Risk Factors – Risks Relating to Our Business, Industry, and Regulatory Approval of Our Product - Our Product Has Existing Competition in the Marketplace . ” Suppliers and Manufacturing 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 most of the components of Aurix are generally readily available on the open market, the bovine thrombin reagent component used for our Aurix product is available exclusively through Pfizer, with whom we have an existing supply agreement.
Furthermore, we have historically sourced Aurix’s ascorbic acid reagent component from a single supplier but have now established dual supply of this component.
While we believe our supply 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.
If a temporary or permanent interruption in the supply of a reagent used in Aurix were to occur, or the manufacturing costs exceed what we can reasonably afford, it could have a material adverse effect on our business.
Risks Related to Our Financial Position Our Revenue Base Is Limited to a Single Product Seeking Market Adoption.
Our current revenue base is limited to our Aurix product, including the Private Label product.
Our revenue from Aurix and the Private Label product has been limited to date.
For the year ended December 31, 2025, we incurred a net loss of approximately $2.5 million.
Even if we succeed in increasing our revenue, we may incur losses and negative operating cash flows in the immediate future.
We May Need Additional Financing and our Ability to Successfully Affect Such Financing Could Be Limited.
We only began re-implementing our commercialization strategy for Aurix in the second half of 2022.

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Gone since FY2024

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 regenerative therapies company focused on developing and marketing products for chronic wound care primarily within the U.S.
Our 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.
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.
CED programs have been employed for a selected number 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.
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).
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 December 31, 2024, 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.
Under the Distribution Agreement, we will supply to Smith+Nephew its own private label of our Aurix product.
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 will pay us up to $2,250,000 for distribution rights and in exchange for our establishment and maintenance of reimbursement in certain categories for the Aurix and the Private Label products.
The description above of the Distribution Agreement is qualified by reference to the full text of such agreement, a copy of which is filed as Exhibit 10.1 to this Annual Report and incorporated herein.
Ostomy Wound Management , 2012; 58(4):36-49.) Customer Concentration Our revenues are derived from the sale of the Aurix product to customers consisting primarily of hospital outpatient wound care clinics and other private practice physicians treating chronic wounds.
The Aurix product became commercially available for sale again in mid-2022 with limited revenues generated during the balance of the year ended December 31, 2022.
Product revenues increased to approximately $1,365,000 for the year ended December 31, 2024 versus approximately $609,000 for the year ended December 31, 2023.
The Company currently has no meaningful business development initiatives outside of the U.S.
Employees The Company had 9 full-time employees as of December 31, 2024 which are all compensated as salaried employees.
Research and Development During the years ended December 31, 2024 and 2023, we incurred no significant costs for research and development activities.
Leading companies in the advanced wound care market include Smith+Nephew, 3M, MoInlycke, and ConvaTec.
Risk Factors – Risks Relating to Distribution of Our Product - Our Product Has Existing Competition in the Marketplace . ” Raw Materials A reagent, bovine thrombin (Thrombin JMI), used for our Aurix product is available exclusively through Pfizer.
If a temporary or permanent interruption in the supply of the reagent were to occur, or the manufacturing costs charged by Pfizer exceed what we can reasonably afford, it would have a material adverse effect on our business.
Risks Related to Our Financial Position Our Revenue Base Is Limited to a Single Product Seeking Market Adoption; We Need Substantial Additional Financing and our Ability to Successfully Affect Such Financing Could Be Limited.
Our current revenue base is limited to our Aurix product, and our Aurix revenue has been limited to date.
For the year ended December 31, 2024, we incurred a net loss of approximately $2.3 million.
Even if we succeed in raising substantial additional funds, we expect to incur losses and negative operating cash flows in the immediate future.
It is substantially uncertain whether we will be able to obtain such financing on satisfactory terms or at all.
We only recently began re-implementing our commercialization strategy for Aurix in the second half of 2022.
The Company reestablished commercial operations in 2022 and generated limited revenues of approximately $112,000 for the year ended December 31, 2022.
For the year ended December 31, 2023, product revenues increased to approximately $609,000 while subsequently increasing to $1,365,000 for the year ended December 31, 2024.
For the years ended December 31, 2024 and 2023, the Company had a net loss of approximately $2.3 million and $3.2 million, respectively.
If we are unable to increase our revenues to secure sufficient capital to fund our operating activities, we may be forced to delay the completion of, or significantly reduce the scope of, our current business plan, delay the pursuit of commercial insurance reimbursement for our wound treatment technologies, and postpone the hiring of new personnel.

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