Spectral Medical Announces Non-Dilutive Financing of Up to $10 Million with Vantive

Core Viewpoint - Spectral Medical Inc. has secured a non-dilutive financing agreement with Vantive US Healthcare LLC for up to US$10 million to support the commercialization of its blood filtration therapy, Toraymyxin™ (PMX) [2][4][5]. Financing Details - The financing consists of a senior secured promissory note with a total principal amount of up to US$10 million, which can be drawn in up to four tranches [2][3]. - The first tranche of US$4 million was triggered on May 6, 2025, upon the execution of the agreement [4]. - The remaining tranches are contingent upon specific milestones outlined in the agreement [4]. Company Strategy and Milestones - The funds will support Spectral's evidence generation strategy and the path to commercialization of PMX, which is designed to remove endotoxin from the bloodstream in patients with sepsis [3][4]. - The company does not anticipate needing additional funding to meet key upcoming milestones, including the release of topline results and U.S. FDA submission [4]. Management Commentary - The CEO of Spectral expressed gratitude for the partnership with Vantive, emphasizing the non-dilutive nature of the funding and the alignment between the two companies [5]. Product Overview - PMX is a therapeutic hemoperfusion device that has been approved for use in Japan and Europe and has been utilized over 360,000 times [11]. - The device is currently seeking U.S. FDA approval and has received Breakthrough Device Designation for the treatment of endotoxic septic shock [11]. Clinical Trial Information - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care versus standard care alone, designed as a 2:1 randomized trial involving 150 patients [12].