Spectral Medical (EDT) Q2 2026 earnings summary

Executive summary

• Completed FDA PMA application for PMX and entered substantive review, marking a major regulatory milestone.

• Positive 12-month follow-up from the Tigris trial showed sustained survival benefit for PMX.

• Commercialization preparations advanced with Vantive, including platform alignment and market readiness.

Financial highlights

• Q2 2026 revenue was $621,000, down 24% year-over-year due to lower reagent and service revenue.

• Six-month revenue rose 9% to $1,512,000, driven by EAA Instrumentation sales.

• Q2 operating expenses dropped 98% to $62,000, mainly from non-cash fair value adjustments and lower clinical costs.

• Q2 net gain was $331,000 versus a $1,933,000 loss last year; six-month loss narrowed to $2,607,000 from $14,539,000.

Outlook and guidance

• Focus remains on supporting FDA review, pre-approval inspections, and operational readiness for PMX launch.

• Actively evaluating financing options to ensure funding beyond commercialization.