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Spectral septic shock treatment approval delayed by US FDA

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Spectral septic shock treatment approval delayed by US FDA

Toronto-based Spectral Medical Inc. said the U.S. Food and Drug Administration asked for more data before it could approve the company's Toraymyxin.

Toraymyxin is a medical device that filters blood and removes an endotoxin from the bloodstream that can cause sepsis, a potentially life-threatening complication of an infection.

The FDA has requested that Spectral conduct further studies and submit data from outside the U.S. and real-world registries.

The premarket approval application was accepted for review by the FDA in July 2017 and was supported by a phase 3 clinical trial.

The company said it would meet with the regulator and discuss a path forward.