PRIME Pivotal Study Published with Strong Clinical Outcomes
PRIME was accepted for publication (published January 2026) and presented at SMFM; reported 56% fewer babies born before 32 weeks and 32% fewer babies born before 35 weeks versus control, reinforcing RCT-level evidence that biomarker-based identification plus a preventive pathway can reduce preterm birth.
Reduction in Neonatal Utilization
Post-PRIME data cited a 20% reduction in NICU admissions, supporting potential health economic benefits and a major driver for payer and state interest in adoption.
Expanded State and Payer Engagement
Exceeded 2025 goals: active discussions expanded to 13 states (vs goal of 6) and 10 payers; two live partner programs launched. Targeting 15–17 states (58%–60% of U.S. births) and 5–7 partner programs by end of 2026 to drive coverage and utilization.
Strategic Commercial and Clinical Leadership Hires
Strengthened leadership team with a new Chief Commercial Officer (Lee Anderson), Chief Medical Officer (Dr. Tiffany Inglis), and Head of Sales & Strategic Accounts (Adrian Lugo) to support commercialization and payer engagement.
European Regulatory Progress
Advancing PreTRM Global regulatory pathway toward CE marking with dossiers expected to be submitted in the coming months; European expert commentary aligns PRIME approach with regional care models, supporting international expansion plans.
Disciplined Expense Management and Improved Losses
Q4 operating expenses down to $9.0M from $9.4M prior year (≈-4.3%). Full-year net loss narrowed to $31.9M from $32.9M in 2024 (≈-3.0%), reflecting reallocation from R&D toward commercial readiness.
Strong Cash Position and Multi-Year Runway
Ended FY2025 with $95.8M in cash, equivalents, and AFS securities and management guidance that current capital supports operations and commercialization milestones through 2028; ATM facility reestablished to preserve optionality.