0001437749-26-009797
SEC filingSeaStar Medical Holding Corporation (ICU) reported FY 2025 net revenue of $1.23 million, a significant +814% YoY increase from $0.14 million in 2024, driven by initial commercialization of QUELIMMUNE pediatric SCD therapy following FDA HDE approval in February 2024, with first shipments in July 2024. Gross profit rose to $1.18 million (95.7% margin) from $0.14 million (100% margin), reflecting $0.05 million COGS. Operating loss improved to -$12.18 million from -$17.84 million, aided by R&D expense reduction to $7.52 million (-17%) and G&A to $5.84 million (-34%). Net loss narrowed to -$12.15 million (-51% YoY) from -$24.83 million, with EPS improving to -$5.86 from -$66.33. Balance sheet strengthened with cash at $12.0 million (up from $1.8 million), total assets $14.2 million, equity $10.4 million (from deficit -$2.2 million). Operating cash use was -$13.6 million, offset by $23.8 million financing inflows, yielding $10.2 million cash increase. Single-segment focus on SCD devices positions for adult AKI pivotal trial readout in 2027, amid going concern doubts and need for funding.
SeaStar Medical (ICU) delivered FY 2025 results reflecting early commercialization momentum post-FDA HDE approval for QUELIMMUNE in Feb 2024. Net revenue surged to $1.23M (+814% YoY from $0.14M), driven by 10 active hospital customers and SAVE Surveillance Registry data showing 76% 60-day survival. Gross profit $1.18M (95.7% margin vs 100%). Operating loss narrowed to -$12.18M from -$17.84M (+32% improvement), with R&D $7.52M (-17% YoY) and G&A $5.84M (-34%). Net loss -$12.15M (-51% YoY from -$24.83M), EPS -$5.86 (vs -$66.33). Balance sheet: cash $12.0M (vs $1.8M), assets $14.2M (vs $4.7M), equity turned positive $10.4M (vs -$2.2M deficit). Cash ops -$13.6M, financing $23.8M (equity raises), net cash +$10.2M.
Single Device Segment revenue $1.23M (+814% YoY), all U.S.-based from QUELIMMUNE sales to pediatric hospitals post-July 2024 launch. No prior-year commercial sales; 2024 $0.14M from limited shipments. Growth from 10 activated customers via SAVE Registry (reduced to 50 patients Mar 2026). No geographic mix outside U.S.; distributor Nuwellis terminated Oct 2024 post-settlement ($0.9M paid). Future tied to adult NEUTRALIZE-AKI trial (178/339 enrolled Mar 2026, topline 2027).
Gross margin 95.7% (vs 100%), first meaningful COGS $0.05M on inventory post-commercial shift. Op margin -989% (improved from -13260%), driven by expense cuts: R&D down on trial efficiencies, G&A via headcount/staffing. No tax benefit; $0.003M expense. Ongoing losses from pre-revenue R&D ($7.52M), but narrowing as revenue ramps.
Ops cash -$13.6M (net loss -$12.2M, adjusted for $0.6M stock comp, working capital changes). Financing $23.8M: $16.1M shares net, $1.8M warrants, $5.9M pre-funded. No investing cash. Liquidity: cash $12.0M, current assets $13.6M vs liabilities $3.7M (working capital $9.9M). Debt minimal ($0.5M notes). Accumulated deficit -$151.7M; going concern doubt noted, needs funding for trials/commercial.
Pivotal NEUTRALIZE-AKI adult AKI trial (topline 2027 PMA submit). BDDs for 6 indications (CRS, HRS, ESRD, cardiac surgery). Commercial: 10 pediatric customers, more activations 2026. Risks: funding needs, trial delays, reimbursement, competition. Plans: direct sales ramp, partnerships, scale manufacturing.