Spectral Medical Inc

Spectral Medical is a Phase 3 company advancing the fight against endotoxic septic shock through an innovative theranostic approach. This unique strategy combines the EAATM Endotoxin Activity Assay, the only FDA-cleared diagnostic for the risk of developing sepsis, with targeted rapid therapy using ToraymyxinTM (PMX). PMX is a Polymyxin B extracorporeal direct hemoadsorption column which is highly effective in removing endotoxin in the bloodstream. Already approved in Japan and Europe (1994 and 2002 respectively), PMX has been safely used on over 340,000 patients. Spectral holds exclusive U.S. development and commercialization rights for PMX since 2009, with a distribution agreement for Canada since 2010. In July 2022, the FDA granted Breakthrough Device Designation to PMX for treating endotoxic septic shock, a condition that affects around 330,000 people in North America annually. Spectral is currently conducting the Tigris Trial, a confirmatory study evaluating PMX combined wi...