$EDT.TO

Spectral Medical Provides Updated 12-Month Tigris Trial Mortality Data

Spectral Medical (EDT.TO) said on Thursday that topline 12-months mortality data for patients enrolled in the Tigris trial have persisted.The trial evaluated the use of Spectral's Polymyxin B Hemoadsorption (PMX) in adults with endotoxic septic shock. Mortality at 12 months was 52.8% with PMX, compared with 66.7% with standard of care alone. The results represented an absolute risk reduction of 13.9%, the company said."The results announced today clearly indicate that the benefits of PMX therapy observed in Tigris persisted over the months following hospital discharge," said Dr. John Kellum, Spectral chief medical officer. "These results provide further evidence of benefit for PMX when used to treat endotoxic septic shock."Spectral Medical shares closed unchanged at $1.39 on Wednesday on the Toronto Stock Exchange.

Spectral Medical and Vantive Announcing Topline 12 Month Follow-Up Results From Spectral's Tigris Trial

Spectral Medical Submits PMX Premarket Approval Application to FDA

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.

Earnings Flash (EDT.TO) Spectral Medical Reports Q1 Revenue $0.9M, Vs $572k a Year Earlier