Spectral delays seeking premarket OK for PMX to mid-May

Executive Summary

• Spectral Medical has delayed its Pre-Market Approval (PMA) submission to the U.S. FDA for its hemoadsorption device, PMX-20R, from the previously targeted Q1 2026 to a window between late April and mid-May 2026.
• The delay is necessitated by the need to incorporate complete 12-month mortality data from the ongoing Tigris study and to finalize non-clinical modules, including human factor engineering testing, to ensure a compliant submission.
• The company anticipates reporting top-line 12-month mortality data in late May or early June 2026, which will support the comprehensive PMA submission for the treatment of endotoxic septic shock.

Key Details

• Submission Timeline: New expected PMA submission window is end of April to mid-May 2026 (previously Q1 2026).
• Reason for Delay: Incorporation of complete 12-month mortality data from the Tigris study and completion of non-clinical module items (specifically human factor engineering testing).
• Data Reporting: Top-line 12-month mortality data from the Tigris study is expected in late May or early June 2026, subject to data analysis completion.
• Product Context: PMX-20R is a therapeutic hemoperfusion device designed to remove endotoxin from the bloodstream for the treatment of endotoxic septic shock.
• Regulatory Status: PMX is approved in Japan and Europe, licensed by Health Canada, and holds U.S. FDA Breakthrough Device Designation for this indication.
• Trial Details: The Tigris trial is a confirmatory, two-to-one randomized study of 150 patients using Bayesian statistics, comparing PMX plus standard care versus standard care alone.
• Market Context: Approximately 330,000 patients are diagnosed with septic shock in North America annually; over 360,000 units of PMX have been sold worldwide to date.

Notable Quotes

• "We continue to work constructively with the FDA to ensure a high-quality PMA submission... The inclusion of longer-term mortality data and completion of the remaining non-clinical components are intended to support a comprehensive submission, and will position PMX for an efficient review process." — Chris Seto, Chief Executive Officer