TriSalus Life Sciences® Inc. (Nasdaq: TLSI) (“TriSalus” or the “Company”), an oncology company integrating novel delivery technology with standard of care therapies to transform treatment for patients with solid tumors, is pleased to announce the publication of clinical data evaluating the use of its proprietary Pressure-Enabled Drug DeliveryTM (PEDDTM) technology in thyroid parenchymal embolization, a new application for the treatment of patients with symptomatic thyroid disease.
Published in the Journal of the Endocrine Society, this retrospective single-center study by Gad et al. evaluated the safety, feasibility, and early efficacy of Pressure-Enabled Thyroid Artery Embolization (PED-TAE) using the TriNav® Infusion System. This novel, minimally invasive technique targets the inferior thyroid arteries to reduce gland size and alleviate symptoms in patients who are not candidates for surgery or conventional therapies.
“We are encouraged to see our technology being evaluated in new areas of clinical need,” said Richard Marshall, MD, TriSalus Medical Director. “This study offers critical insights into how TriNav’s Pressure-Enabled Drug Delivery approach may help address therapeutic delivery challenges for patients with thyroid disease and is an expansion beyond our historic focus on improving treatment of liver cancers.”
Key Study Highlights:
- Population: 22 patients with symptomatic thyroid disease (benign thyroid nodules or multinodular goiters) (median age: 59)
- Procedure: Pressure-enabled embolization via the inferior thyroid artery; 45% had unilateral treatment and 55% bilateral
- Outcomes:
- 100% technical and clinical success (technical success defined as successful catheterization and embolization. Clinical success measured as the absence of non-target embolization, target volume reduction, and/or normalization of thyroid function, when appropriate.)
- 71% (5 of 7) of patients with hyperthyroidism achieved normal thyroid function (euthyroid)
- 73% mean reduction in thyroid gland volume at 6 months (n=18)
- No major complications or neurovascular events
- Mild post-procedure symptoms (e.g., neck discomfort) reported in 81% of patients, resolving within two weeks
- No patients developed hypothyroidism following the procedure
The authors conclude that PED-TAE is a safe and feasible treatment option for large goiters and may offer an alternative to more invasive approaches for treating large benign thyroid nodules and benign multinodular goiters. However, prospective research is needed to establish long-term efficacy.
Additionally, a multi-institutional registry study (PROTECT, NCT06868459) has been initiated by Juan C. Camacho, MD and is underway in collaboration with TriSalus Life Sciences to further validate these findings and evaluate broader applicability in a multi-center setting.
“These early results lay the foundation for a broader evaluation of pressure-enabled embolization in the management of benign thyroid disease,” said Juan C. Camacho, MD, lead investigator of the PROTECT registry and interventional radiologist at Sarasota Memorial Hospital. “We are excited to collaborate with TriSalus through the PROTECT registry to grow the body of data and further define the role of this technique in clinical practice.”
“TriSalus continues to support innovations in embolization techniques,” said CEO Mary Szela. “While these results are early, they reflect growing interest in our platform to expand minimally invasive treatment options for patients. We are grateful to the team at Sarasota Memorial Hospital for leading this pioneering work, and are excited to collaborate on the PROTECT registry.”
