Spectral Medical Provides Update on PMA Submission Timing for PMX-20R

Executive Summary

• Spectral Medical now expects to submit its PMA for the PMX hemoadsorption device to the U.S. FDA between late April and mid‑May 2026, later than the previously disclosed Q1 2026 target.
• The revised schedule reflects the need to incorporate complete 12‑month mortality data from the Tigris study and finish remaining non‑clinical module work (e.g., human factors engineering testing).
• Top‑line 12‑month mortality results are anticipated in late May or early June 2026, pending final data analysis.

Key Details

• Updated PMA submission window: End of April – mid‑May 2026 (vs. prior Q1 2026 target).
• Reason for delay: Inclusion of full 12‑month mortality outcomes from the Tigris trial and completion of non‑clinical modules, including human factors engineering testing.
• Clinical data timeline: Top‑line 12‑month mortality results expected late May/early June 2026.
• Regulatory context: FDA feedback requires the additional data and module completions for a compliant submission.
• CEO comment: Chris Seto emphasized that the longer‑term mortality data and completed non‑clinical components are intended to support a comprehensive, high‑quality PMA and facilitate an efficient review.

Notable Quotes

“We continue to work constructively with the FDA to ensure a high-quality PMA submission,” said Chris Seto, Chief Executive Officer of Spectral Medical. “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.”