TriSalus Life Sciences, Inc. develops oncology-focused drug-delivery technology and an investigational immunotherapy program for solid tumors. Its Pressure-Enabled Drug Delivery, or PEDD, platform is used through the TriNav Infusion System in interventional radiology procedures, including TARE and TACE, for primary liver cancer and liver metastases.
Company news centers on TriNav commercial performance, clinical and preclinical data for PEDD, studies in liver tumors, research involving nelitolimod, and presentations to interventional radiology audiences. Updates also include quarterly financial results, revenue guidance, capital actions, shareholder voting matters and governance changes tied to the company’s oncology technology strategy.
TriSalus Life Sciences (Nasdaq: TLSI) has secured a new Level II HCPCS code (C8004) from the Centers for Medicare & Medicaid Services for its TriNav® Infusion System, effective April 1, 2025. The code specifically covers simulation angiograms used in pre-treatment mapping for transarterial radioembolization (TARE).
The new code, which carries a Medicare payment rate of $11,341 under APC 5193, will be applicable in hospital outpatient departments and ambulatory surgical centers. This development validates TriNav's role in optimizing Y90 dose delivery and ensures reimbursement clarity for both mapping and treatment procedures.
The pressure-generating catheter system features a one-way valve technology that enhances the accuracy of Y90 dose delivery and improves personalized dosimetry through better prediction capabilities and higher tumor-to-normal tissue ratios.
TriSalus Life Sciences (Nasdaq: TLSI) researchers have received two prestigious JVIR Top Paper Awards for their study demonstrating the superior performance of the TriNav Infusion System in liver tumor treatment. The study, which will be honored at the 2025 Society for Interventional Radiology meeting in Nashville, received the JVIR Editor's Award for Distinguished Laboratory Investigation and the JVIR People's Choice Award for Most Downloaded Articles.
The research, conducted using a porcine liver tumor model, revealed significant improvements in therapeutic delivery:
- 117% increase in tumor penetration for lobar infusions (p=0.004)
- 39% increase in tumor penetration for selective infusions (p=0.032)
- Lobar infusions using TriNav showed equivalent tumor penetration to selective delivery using traditional microcatheters (p=0.497)
The study utilized machine learning algorithms to quantify tumor penetration at a millimeter scale, contributing to the evidence supporting Pressure-Enabled Drug Delivery's (PEDD) effectiveness in treating primary and metastatic liver cancers.
TriSalus Life Sciences (Nasdaq: TLSI) has appointed two healthcare industry veterans to its Board of Directors, effective January 29, 2025. William J. Valle, former CEO of Fresenius Medical Care North America, brings expertise in medical device commercialization and reimbursement. Dr. Gary B. Gordon, former Vice President of Oncology at AbbVie, contributes extensive experience in oncology drug development.
Valle previously managed over 2,400 outpatient facilities and led the integration of critical business functions at Fresenius. Gordon played a key role in developing AbbVie's oncology franchise, including overseeing venetoclax approval and leading major acquisitions. Both appointments aim to advance TriSalus' Pressure-Enabled Drug Delivery™ (PEDD™) technology and Pancreatic Retrograde Venous Infusion (PRVI™) System for improved therapeutic delivery to solid tumors.
TriSalus Life Sciences (Nasdaq: TLSI) has announced a $10 million drawdown from its existing $50 million credit agreement with OrbiMed, a healthcare investment firm. This drawdown was triggered by achieving a product revenue-based milestone of $30 million for the trailing 12-months ending January 31, 2025. With this latest tranche, TriSalus has now accessed a total of $35 million from the credit facility provided by OrbiMed.
TriSalus Life Sciences (NASDAQ: TLSI) reported strong preliminary Q4 2024 results, with revenue reaching $8.3 million, up 44% year-over-year. Full-year 2024 revenue grew 59% to $29.4 million, driven by the TriNav® Infusion System.
Operating Cash Flow improved to ($5.6) million in Q4 2024 from ($10.8) million in Q3. The company ended 2024 with $8.5 million in cash and expects to secure an additional $10 million from OrbiMed in Q1 2025. Management projects over 50% revenue growth in 2025, anticipating positive full-year EBITDA and positive cash flow in H2 2025.
TriSalus Life Sciences (NASDAQ: TLSI) has published research demonstrating the superior performance of their TriNav Infusion System using Pressure-Enabled Drug Delivery (PEDD) technology in delivering Embospheres to liver tumors. The study, published in the Journal of Vascular and Interventional Radiology, showed significant improvements compared to traditional microcatheters:
- 227% increase in Embospheres concentration within tumor tissue
- Improved tumor-to-normal ratio from 2.7 to 4.2
- 209% increase in peritumoral delivery
The research was conducted using a transgenic porcine liver tumor model, utilizing fluorescent imaging and deep-learning algorithms for precise quantification. These results support PEDD's potential to enhance therapeutic delivery while protecting healthy tissue in liver cancer treatments.
TriSalus Life Sciences (NASDAQ: TLSI) announced key changes to its executive leadership team, effective January 6, 2025. James Young, previously Senior Vice President of Investor Relations and Treasurer, has been appointed as Chief Financial Officer, succeeding Sean Murphy who will continue as Chief Manufacturing, Strategy and Business Development Officer and Board member.
The company also promoted Dr. Richard B. Marshak to Chief Commercial Officer and Jodi Devlin to Chief of Clinical Strategy and Operations. Young brings 33 years of experience from Abbott Laboratories, Marshak has extensive leadership experience including CEO roles, and Devlin brings over 30 years of experience in biotech, medical devices, and pharmaceuticals.
CEO Mary Szela emphasized that these changes reflect the company's momentum and position TriSalus to achieve its 2025 goals, highlighting the 18-month transition planning between Young and Murphy to ensure operational continuity.
TriSalus Life Sciences reported strong Q3 2024 results with revenues of $7.3 million, up 42% year-over-year, and nine-month revenues of $21.2 million, up 66%. The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter for larger vessels, expanding into the $375 million embolization market. For 2025, TriSalus projects over 50% sales growth, 20%+ reduction in operating expenses, and expects positive EBITDA and cash flow in H2 2025. The company presented positive Phase 1 data from the PERIO-01 trial in uveal melanoma patients and is seeking strategic partnerships for further development.
TriSalus Life Sciences (Nasdaq: TLSI) has launched the TriNav® LV Infusion System and TriGuide™ Guiding Catheter, expanding its portfolio of Pressure-Enabled Drug Delivery (PEDD™) devices for liver and pancreatic tumor treatment. The TriNav LV Infusion System, designed for vessels 3.5-5.0 mm in diameter, broadens patient eligibility for PEDD technology. The TriGuide Guiding Catheters feature a larger inner diameter and reverse curve design, facilitating femoral access and improving procedural efficiency. Early users reported a 97% satisfaction rate. The devices are eligible for existing HCPCS codes, ensuring seamless reimbursement. CEO Mary Szela emphasized the company's commitment to advancing their pipeline and improving patient outcomes.
TriSalus Life Sciences (Nasdaq: TLSI) has scheduled its third quarter 2024 financial results conference call for Thursday, November 14, 2024, at 9:00 a.m. ET. The company, which focuses on improving outcomes for liver and pancreatic cancer patients through advanced delivery technology and immunotherapy, will discuss Q3 2024 results and provide a business update. The financial results press release will be issued before the call. The event will be accessible via webcast on the company's investor relations website, with a replay available afterward. Interested parties can register online to receive dial-in details.