AURX — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-14

• ● our reliance on several single source suppliers and our ability to source raw materials at affordable costs; the interruption in our supply chain for a reagent component of Aurix and our ability to remedy the supply outage in a sufficient and timely manner;

• 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 reimbur…

• In 2023 and 2024, we submitted public comments to CMS as part of its annual rule-making procedures under the Physician Fee Schedule ("PFS") for payments to clinicians in primarily POS 11 (physician offices) in both 2023 and 2024. In November 2024, CMS issued its final PFS for calendar 2025 and estab…

• We outsource the manufacturing of various Aurix product components to contract manufacturers. While we believe these manufacturers demonstrate competency, reliability and stability, there is no assurance that one or more of them will not experience an interruption or inability to provide us with the…

• While most of the components of Aurix are generally readily available on the open market, a reagent used for Aurix - bovine thrombin (Thrombin-JMI or “TJMI”) - is available solely through Pfizer, with which we have a long-standing supply agreement. Historically, we have used single suppliers for sev…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• our reliance on several single source suppliers and our ability to source raw materials at affordable costs;

• 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 reimbur…

• 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 Dece…

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

• 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.

Text added vs the prior filing · source: 10-Q · 2026-08-14

• We Recently Have Experienced an Interruption in our Supply Chain for a Reagent Component of Aurix that Could Have a Material Adverse Effect on our Business.

• We outsource the manufacturing of various Aurix product components to contract manufacturers. While we believe these manufacturers demonstrate competency, reliability and stability, there is no assurance that one or more of them will not experience an interruption or inability to provide us with the…

• While most of the components of Aurix are generally readily available on the open market, a reagent used for Aurix - bovine thrombin (Thrombin-JMI or “TJMI”) - is available solely through Pfizer, with which we have a long-standing supply agreement. Historically, we have used single suppliers for sev…

• In Spring 2026, we became aware that Pfizer was experiencing challenges regarding regular uninterrupted supply of commercially available TJMI. Our understanding has been that the TJMI supply challenges related to a diluent co-packaged with the lyophilized thrombin vial in the TJMI product. We use on…

• We had previously been addressing the potential unavailability of TJMI in whole or in part via possible alternative supply arrangements. Upon notice of TJMI outage in late June 2026, we initiated contact with an FDA drug shortage group to discuss possible mitigation approaches to an impending Aurix …