Spectral Medical Receives US$3 Million From Vantive

Core Viewpoint - Spectral Medical Inc. has secured a US$3 million Tranche B advance from Vantive US Healthcare LLC, enhancing its financial position to support regulatory and commercialization efforts for its product PMX [1][2][3] Financial Position - The Tranche B advance strengthens Spectral's balance sheet and will be utilized for regulatory preparations, commercialization, and general working capital [2] - The company does not foresee the need for additional funding beyond the current promissory note to achieve key milestones, including U.S. FDA submission and PMX commercialization [2] Funding Details - Under the promissory note, Vantive can provide up to US$10 million in four tranches, with the current cumulative draw being US$7 million after the Tranche B advance and the initial US$4 million Tranche A advance [3] Product Overview - Spectral is focused on obtaining U.S. FDA approval for PMX, a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream, which is critical in treating septic shock [5][6] - PMX has been approved for use in Japan and Europe, with over 360,000 units sold globally [6] Clinical Trials - The Tigris Trial is a confirmatory study comparing PMX in addition to standard care against standard care alone, involving 150 patients and utilizing Bayesian statistics [7]