Landmark Real-World Evidence Publication Validating PEDD
Published largest real-world evidence study of PEDD (603 PEDD patients matched to >16,200 non-PEDD patients from a 300M-patient claims database covering 96% of US payers; cohort: 515 TACE, 88 TARE). Key outcomes: post-procedure fatigue 20.9% vs 26.4% (absolute -5.5pp), lymphopenia 0.6% vs 5.2% (absolute -4.6pp, ~88% relative reduction), TACE 30-day inpatient admissions 8% vs 20.5% (absolute -12.5pp, >50% reduction), PEDD delivered ~48% more doxorubicin per procedure. Per-patient downstream cost avoidance ≈ $7.7k (≈ $3.1k from fewer inpatient stays + $4.6k from fewer complications).
Strong Clinical Pipeline and Growing Evidence Base
10 active studies across 24 sites (>400 TriNav-treated patients); two new prospective trials beginning (PRESSURE at Stanford randomized TriNav vs TARE; PREDICT at MD Anderson for hypovascular tumors). Two completed investigator-initiated trials (TETHER at MGH, TRI-FI 90 at MD Anderson) targeting submission this quarter, plus two large retrospective TARE-in-HCC studies initiated.
Expansion into Multiple High-Potential Indications
Momentum in new applications: uterine artery embolization (median dominant fibroid volume reduction 97.5% vs historical ~50%; 100% technical success, no device-related complications), PROTECT thyroid registry (100% technical/clinical success; 73% thyroid size reduction; 71% normalization rate), genicular artery embolization pilot moving to formal trial. Combined US addressable market across liver and new applications ≈ $2.5 billion.
Commercial Organization Build and Leadership Added
Commercial footprint materially expanded (sales organization more than doubled; added senior VP of Sales & Commercial Ops Chris Sowd). 60% of territories performed in line with expectations during transition, organization largely in place by May; expected rep ramp 6–9 months supporting multi‑year growth.
Improved Gross Margin and Solid Cash Position
Q1 gross margin 86% vs 84% year-ago (+2 percentage points) driven by lower average unit cost and manufacturing improvements. Cash and cash equivalents $56.6M as of 03/31/2026, stated as sufficient to fund strategic growth plan.