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TriSalus Life Sciences Announces Publication of Safety and Efficacy Results for a Novel Pressure-Enabled Thyroid Embolization Technique

via Business Wire

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.”

About TriSalus Life Sciences

TriSalus Life Sciences® is an oncology focused medical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technology applications. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. The PEDD technology is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. Nelitolimod, the Company’s investigational immunotherapeutic candidate, is designed to treat the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. The Company is in the final stages of data completion for a number of phase 1 clinical trials and will begin exploring partnership opportunities for development. In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on X (formerly Twitter) and LinkedIn.

For more about TriSalus Life Sciences, visit www.trisaluslifesci.com

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby under the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “become,” “may,” “intend,” “will,” “expect,” “anticipate,” “believe” or other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding TriSalus’s business, the commercial potential of its TriNav Infusion System, TriSalus’s proprietary PEDD approach, the potential therapeutic benefits and commercial potential of Nelitolimod, and TriSalus’s technologies and other products in development. Such statements are subject to certain risks and uncertainties, including, but not limited to, those inherent in the process of developing and commercializing medical devices that are safe and effective for human use, discovering, developing and commercializing medicines that are safe and effective to use as human therapeutics, and the endeavor of building a business around such medical devices and medicines.

TriSalus’s forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although TriSalus’s forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by TriSalus. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning TriSalus’s products and programs are described in additional detail in TriSalus’s annual report on Form 10-K, and most recent Form 10-Q, which are on file with the Securities and Exchange Commission (the "SEC") and available at the SEC's website (www.SEC.gov). These forward-looking statements are made as of the date of this press release, and TriSalus assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.

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