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Spectral Medical (EDT) investor relations material
Spectral Medical Q2 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
- Tigris trial targets full enrollment by Q1 2025, with FDA submission expected by Q3 2025.EDT
Status update8 Jul 2026 - Tigris trial fully enrolled; top-line results due August, FDA submission in October, $10M Vantive funding.EDT
Status update8 Jul 2026 - Revenue up 56% and net loss narrowed as PMX advances toward FDA submission with new funding.EDT
Q1 20261 Jun 2026 - Tigris trial enrollment surged, $8.5M financing secured, and 10-year Baxter partnership extended.EDT
AGM 202429 May 2026 - TIGRIS enrollment, Vantive financing, and FDA submission drive momentum for 2026 launch.EDT
AGM 202529 May 2026 - PMA submission moved to Q1 2026; commercialization and financial plans remain on track.EDT
Status update29 May 2026 - Tigris trial showed robust 90-day mortality benefit, paving the way for FDA submission and commercialization.EDT
Status update29 May 2026 - Accelerated trial progress, revenue growth, and new funding set stage for late-2024 milestones.EDT
Q2 202421 Apr 2026 - Tigris trial nears completion amid supply chain delays; Q3 revenue up, but net loss widens.EDT
Q3 202421 Apr 2026
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