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Spectral Medical Submits PMX Premarket Approval Application to FDA

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Spectral Medical (EDT.TO) has submitted its premarket approval (PMA) application to the U.S. Food and Drug Administration for PMX, the company said on Friday.

PMX is Spectral's endotoxin removal therapy for patients with endotoxic septic shock (ESS). The submission is supported by data from the company's Tigris trial, a Phase 3 follow-on study evaluating PMX in patients with ESS. Complete results of the Tigris trial out to 90 days were published last March in the journal The Lancet Respiratory Medicine.

"This PMA submission represents a defining milestone for Spectral and reflects years of focused clinical, regulatory and operational execution," said chief executive Chris Seto.

"We believe the totality of evidence supporting PMX demonstrates that a targeted therapy for endotoxic septic shock is beneficial. This is an area of critical unmet medical need with limited therapeutic innovation over the past several decades."

Spectral Medical shares closed down $0.02, to $1.40, on Thursday, on the Toronto Stock Exchange.

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