Commercial Launch of PancreaSure
PancreaSure commercially launched in September 2025 with initial adoption at high-risk surveillance centers; 6 centers regularly using the test at year-end and 4 new centers added in Q4. UC Health >100 tests performed; strong order activity reported at Northwestern Medicine and HonorHealth.
Attractive Medicare Pricing Secured
Secured a Medicare reimbursement rate of USD 897 and an appropriate billing code, positioning the company for substantial per-test reimbursement once coverage decisions are granted.
Strong Scientific and Clinical Dissemination
Five clinical studies published in scientific journals, PancreaSure data selected for podium presentations at five meetings, and the CLARITI study named best of DDW, demonstrating robust scientific validation and visibility.
Progress on Regulatory State Approvals
Laboratory/service approvals in 48 of 50 U.S. states (96%); California approval received in January 2026 and New York approval pending (inspection completed with 4 minor findings already addressed).
Funding and Improved Cost Discipline
Completed a rights issue of SEK 100 million (88% subscribed by existing shareholders) delivering a net cash injection of SEK 69.8 million; earlier fundraising referenced of over SEK 140 million to support launch and studies. Achieved reduced operating losses and lower cash burn via R&D cost reductions and cost discipline.
Operational and Commercial Team Build-Out
Hired 3 strategic account managers with industry experience (Exact Sciences, Quest, Myriad) to expand outreach, accelerate pipeline conversion, integrate the test into center protocols, and deepen relationships across surveillance center teams.
Clinical and Reimbursement Strategy Underway
Three clinical validation studies completed (two published with AFFIRM pending publication), two clinical utility studies underway, and a planned registry targeting ~400 patients in 2026; plan to submit for Medicare coverage mid-2026 with rolling data updates.
Financial Efficiency Improvements
Q4 operating loss narrowed to SEK 16.4 million from SEK 30.1 million year-over-year (approximate reduction of 45.5%), and cash burn in Q4 was SEK 6.6 million/month, below prior guidance of SEK 8–10 million/month (17.5%–34% lower).