Record Sales and Strong Top-Line Growth
Net sales of SEK 241 million in Q1 2026 with organic top-line growth of 23% (18% excluding U.S. CAP trial revenue). Management described this as a record quarter with broad-based momentum across core businesses.
Profitability and Cash Flow
EBITDA of 21% for the quarter (24% underlying excluding SEK 7m nonrecurring heart go-to-market costs); EBIT 13%. Operating cash flow SEK 65 million and positive total cash flow for the second consecutive quarter; cash position SEK 308 million at quarter end.
Thoracic Segment Outperformance
Thoracic sales SEK 160 million with organic growth of 27% (19% excluding CAP revenue). Thoracic gross margin strong at 83% driven by pricing actions and product mix.
EVLP Momentum — Consumables and Hub Model
EVLP disposables grew 56% in Q1. Successful OPO EVLP hub pilot (10 EVLPs performed); second OPO onboarded in early Q2 and 4–5 additional OPOs identified in rollout pipeline, supporting continued EVLP adoption.
Kidney Sales Surge
Abdominal net sales SEK 66 million with organic growth 24%; kidney sales up 63% in local currencies, driven by growing interest for Kidney Assist Transport in North America (U.S. and Canada) and new accounts.
Flowhawk Rapid Adoption
Services software Flowhawk grew 62% in Q1 and is now implemented at 6 of the 10 largest U.S. transplant programs, indicating strong enterprise adoption potential.
Compelling Clinical Data for Heart
U.S. PRESERVE trial (141 patients, 14 sites) met predefined efficacy and safety endpoints; severe PGD 7.9% in U.S. data. European randomized trial: ex vivo group reduced severe PGD by 76% (20%→5%) and achieved a 6% absolute increase in 1-year survival; primary endpoint statistically significant at day 365. European DCD direct procurement proof-of-concept: 30-day survival 98%, severe PGD 5%.
Regulatory and Market Access Progress
Heart machine and disposables CE-marked; compassionate-use sales in Europe and Australia already occurring. U.S. heart regulatory file being prepared for FDA submission (planned for summer). Liver Assist holds FDA Breakthrough Device designation, approved IDE and CMS funding; company preparing for QSA discussion on U.S. regulatory route.