FDA Clarifies Path for Spectral Medical’s Sepsis Device PMA

Spectral Medical held an in-person 100-Day Meeting with the FDA on September 11, 2026, over its premarket approval application for Toraymyxin (PMX), a hemoperfusion device for endotoxic septic shock. The agency had sent a deficiency letter ahead of the meeting identifying items needing more information, analysis, and testing — but, according to Spectral, did not ask for an additional clinical trial to resolve them.

What a 100-Day Meeting is for

A 100-Day Meeting is a standard checkpoint in the FDA's PMA review process, held roughly 100 days after a PMA is formally filed, giving the sponsor and the agency a structured venue to align on outstanding review items before the substantive review continues. In Spectral's case, the FDA used a deficiency letter sent several days ahead of the meeting to lay out specifically what it wanted addressed — additional information, analyses, testing, and clarification on discrete items — rather than raising them for the first time in the room.

That sequencing matters operationally: it let Spectral and the FDA use the meeting itself to focus on resolving those items rather than surfacing them. Spectral's own account of the outcome is notable mainly for what didn't happen — the FDA did not request an additional clinical trial, which in a device PMA can be the difference between a data-gathering exercise measured in months and one measured in years.

The clinical case the PMA is built on

PMX's submission rests on the Tigris trial, a U.S. multicenter, randomized, controlled Phase 3 study that enrolled adults in endotoxic septic shock, defined using Spectral's own FDA-cleared Endotoxin Activity Assay (EAA) — a blood test that returns results in about 30 minutes and was used in Tigris to select patients with an EAA level between 0.60 and 0.90. In the trial's topline results, PMX met its primary endpoint of day-28 mortality with a posterior probability of benefit of 95.3%, just clearing the 95% threshold Spectral had set going in.

That EAA-guided patient selection is itself part of the regulatory story: it is the mechanism Spectral is proposing to identify which septic shock patients are likely to benefit from PMX, rather than treating septic shock as a single undifferentiated population. PMX has already been approved in Japan and the EU and is licensed in Canada, with more than 360,000 units sold worldwide historically — giving the U.S. submission a substantial international use record to draw on, even as the FDA's domestic PMA review proceeds on its own evidentiary track.

• May 29, 2026 — Spectral announces PMA submission to the FDA for PMX.
• June 25, 2026 — FDA completes filing review and formally files the PMA.
• September 11, 2026 — FDA deficiency letter followed by an in-person 100-Day Meeting; no additional clinical trial requested.

“We were pleased with the constructive dialogue with FDA during the in-person 100-Day Meeting.” Chris Seto, CEO, Spectral Medical

Frequently asked questions

What is Toraymyxin and what does it treat?

Toraymyxin (PMX) is a single-use therapeutic hemoperfusion device that removes endotoxin from the bloodstream of patients in endotoxic septic shock. Patient selection is guided by Spectral's own FDA-cleared Endotoxin Activity Assay (EAA), a blood test that identifies patients with elevated endotoxin activity.

What happened at the 100-Day Meeting?

As part of its substantive review of Spectral's PMA, the FDA sent a deficiency letter several days before the scheduled in-person 100-Day Meeting, identifying items requiring additional information, analyses, testing, and clarification. Spectral says the meeting let the company focus discussion on those items, and that the FDA did not request an additional clinical trial as part of the response.

What is the PMA's clinical basis?

The PMA rests on Spectral's Tigris trial, a U.S. multicenter, randomized, controlled Phase 3 study of PMX in adults with endotoxic septic shock (defined by an EAA level of 0.60 to 0.90). Topline results showed PMX met its primary endpoint of day-28 mortality, with a posterior probability of benefit of 95.3% — just over the 95% threshold Spectral had set.

What's the regulatory timeline so far?

Spectral announced its PMA submission to the FDA on May 29, 2026; the FDA completed its filing review and formally filed the application on June 25, 2026. The deficiency letter and 100-Day Meeting followed on September 11, 2026. Spectral says it does not currently expect the additional requested activities to materially change its overall regulatory timeline. PMX previously received FDA Breakthrough Device Designation and is already approved in Japan and the EU and licensed in Canada.