Sepsis Trial Update Sending Shares of this Medical Device Maker Higher

This Phase 3 company is seeking U.S. FDA approval for its unique product for the treatment of patients with septic shock, and shares are moving up.

Late-stage theranostic company Spectral Medical Inc. (TSX: EDT) is advancing therapeutic options for sepsis and septic shock. Spectral announced in a press release today results from its Tigris trial, a Phase 3 follow-on study evaluating the use of Polymyxin B Hemoperfusion (“PMX”) in a randomized controlled trial of adults treated for endotoxemia and septic shock.

The study which had robust enrollment, and the company has entered the final push to fully enroll and finish the Tigris trial, which could be completed as early as December 2024.

Toraymyxin™ (“PMX”) is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream and is guided by the firm's Endotoxin Activity Assay, the only FDA-cleared diagnostic for the risk of developing sepsis. It is already approved in Japan and Europe.

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