Spectral Medical (EDT) Status update summary

Regulatory and clinical progress

• Achieved full enrollment in the TIGRIS confirmatory trial, with 157 patients and 100 treated with PMX, marking a significant milestone in sepsis research.

• Positive top-line TIGRIS results showed clinically meaningful benefits at 28 and 90 days, reinforcing confidence in PMX and supporting regulatory advancement.

• PMA submission timeline shifted from October 2025 to early Q1 2026 to incorporate late FDA feedback, aiming for a more robust and comprehensive filing.

• All major PMA modules are nearly complete, with final updates focused on manufacturing quality to meet current FDA standards.

• The FDA review process will include a 15-day acknowledgment, 45-day initial review, and a 180-day substantive review, with possible advisory committee involvement.

Manuscript publication and clinical evidence

• TIGRIS manuscript, including additional analyses, is in peer review and targeted for publication in Q1 2026, serving as a key milestone for external validation.

• One-year survival data from TIGRIS will be available before summer and is expected to support the primary findings.

• Publication and peer-reviewed validation are seen as critical for clinician confidence and reimbursement discussions.

Commercialization readiness

• Commercialization efforts with Vantive are tightly aligned with regulatory milestones, targeting immediate U.S. launch post-approval and near-term Canadian expansion.

• Vantive is leveraging its strong ICU footprint, experienced sales force, and medical education resources to ensure market readiness.

• Health economic analysis of TIGRIS data is underway to demonstrate cost savings and support hospital adoption.

• Manufacturing and supply chain coordination with Toray is ongoing to ensure inventory and logistics are prepared for launch.

• Clinical education and early adopter engagement strategies are being developed to support ICU adoption.