Spectral Medical Announces U.S. FDA Filing of PMA Application for PMX

Executive Summary

• The U.S. FDA has formally filed Spectral Medical’s Premarket Approval (PMA) application for PMX, initiating the substantive review phase for the endotoxin removal therapy targeting endotoxic septic shock.
• The filing follows the successful completion of the Phase 3 Tigris trial, which met its primary endpoint with a 95.3% probability of benefit for 28-day all-cause mortality and >99% probability for 90-day mortality.
• Complete 90-day trial data, published in The Lancet Respiratory Medicine, demonstrates a sustained survival benefit with an absolute risk reduction of 13.9% at 12 months.

Key Details

• FDA formally filed the PMA application for PMX, confirming the application contains all necessary clinical, non-clinical, manufacturing, and quality system information for substantive review.
• PMX is a therapeutic hemoperfusion device that removes endotoxin from the bloodstream, guided by the FDA-cleared Endotoxin Activity Assay (EAA™).
• Tigris trial design: Confirmatory Phase 3, 2:1 randomized study of 150 patients, utilizing a Bayesian statistical framework.
• Primary endpoint results: 95.3% probability of benefit for 28-day all-cause mortality; >99% probability of benefit for 90-day mortality.
• Mortality risk reduction: Absolute risk reduction of 10.3% at 28 days (NNT = 9.7) and 15.5% at 90 days (NNT = 6.5).
• Long-term follow-up: 12-month survival benefit persisted, with mortality rates of 52.8% in PMX-treated patients vs. 66.7% in the standard-of-care group (absolute risk reduction of 13.9%).
• Complete 90-day results published in March/May 2026 in The Lancet Respiratory Medicine; trial methodology detailed in “Bayesian methods: a potential path forward for sepsis trials”.
• PMX is currently approved in Japan and Europe, licensed by Health Canada, with approximately 360,000 units sold worldwide to date.
• FDA granted Breakthrough Device Designation for PMX in July 2022; ~330,000 patients are diagnosed with septic shock in North America annually.
• Spectral will continue close engagement with the FDA during the substantive review phase and will provide updates as appropriate.

Notable Quotes

• Chris Seto, CEO: “The FDA’s filing of our PMA application represents a defining milestone for Spectral and reflects years of focused clinical, regulatory and operational execution... We look forward to continuing our engagement with the Agency during the review process.”
• John A. Kellum, CMO: “Endotoxic septic shock remains one of the most challenging conditions encountered in critical care medicine... The Tigris trial further strengthens the clinical evidence supporting PMX... We are encouraged to have reached this important stage of the regulatory process.”