Spectral Medical Inc. announced an extension to its supply and distribution agreement with Baxter Healthcare Corporation. originally entered into in February 2020. Spectral is a Phase 3 company seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, Toraymyxin??

("PMX"). PMX is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by Spectral's Endotoxin Activity Assay (EAA??), the only diagnostic currently cleared by U.S. FDA for the risk of developing sepsis. Under the terms of the Amended Agreement, Baxter's exclusive rights to supply and distribute PMX products will be in effect for ten (10) years following the date that the U.S. FDA marketing authorization for PMX products in the United States is obtained.

Upon Baxter International Inc.'s previously announced planned separation of its Kidney Care business (or any other separation of all or part of such Kidney Care business) into an independent company, the rights and obligations under the Amended Agreement will be assigned or otherwise transferred by Baxter to the new Kidney Care company. Under the terms of the amended Agreement, once 90 patients were enrolled in Spectral's PMX-focused Tigris Trial, Baxter had the option to make a milestone payment to Spectral to maintain its exclusive distribution rights for PMX products in theUnited States and Canada. On February 15, 2024, Spectral announced that it had reached the 90-patient enrollment threshold and provided written notification to Baxter of this achievement.

Subsequently, Baxter exercised its option to maintain exclusive distribution rights.