TriSalus (TLSI) Initiates Patient Enrollment for PREDICTT Liver Tumor Clinical Trial

Key Takeaways

• ~20 patients with unresectable liver tumors will be enrolled
• TriNav system uses pressure to improve Y90 microsphere distribution
• Trial compares tumor‑to‑normal liver enhancement ratios via CT/SPECT
• Positive results could set new standard for liver radioembolization
• Collaboration with MD Anderson adds clinical credibility

Pulse Analysis

The PREDICTT trial marks a pivotal step for TriSalus as it moves its Pressure‑Enabled Drug Delivery (PEDD) technology from concept to clinical validation. By leveraging the TriNav Infusion System, the study seeks to overcome a long‑standing limitation of Y90 radioembolization: uneven microsphere dispersion that can leave portions of the tumor under‑dosed while exposing healthy liver tissue to excess radiation. The pressure‑based infusion method promises a more uniform delivery, potentially enhancing tumor‑to‑normal liver enhancement ratios—a key metric that correlates with treatment response and patient outcomes.

Conducted at the world‑renowned MD Anderson Cancer Center, the trial’s design reflects a rigorous, investigator‑led approach. Enrolling roughly 20 adult patients with primary or metastatic liver lesions, the study will employ high‑resolution CT and SPECT/CT imaging to track microsphere placement in real time. These imaging modalities enable precise quantification of radiation dose distribution, allowing researchers to directly compare the PEDD system against conventional delivery techniques. The modest sample size is typical for early‑phase feasibility studies, yet the data generated could inform larger, multicenter trials and accelerate regulatory pathways.

Beyond the scientific implications, the trial carries significant commercial weight. Success would not only validate TriSalus’s core technology but also open doors to partnerships with interventional radiology groups and oncology centers seeking to improve outcomes for hard‑to‑treat liver cancers. In a market where Y90 therapies generate billions in annual revenue, a differentiated delivery platform could capture a meaningful share, especially as clinicians prioritize precision and safety. Moreover, the collaboration with MD Anderson enhances credibility, potentially easing future fundraising and positioning TriSalus for strategic acquisition or licensing deals.