Full Transcript: TriSalus Life Sciences Q2 2026 Earnings Call

TriSalus Life Sciences (NASDAQ: TLSI ) reported second-quarter financial results on Thursday. The transcript from the company's second-quarter earnings call has been provided below. APIs provide real-time access to earnings call transcripts and financial data. Visit to learn more.

4 million, reflecting sequential and year-over-year growth, driven by the expansion of their TRINAV system and commercial infrastructure. Significant strategic initiatives include the expansion of reimbursement for TRINAV into office-based labs (OBLs) and ongoing clinical trials to validate the pressure-enabled drug delivery (PEDD) technology. The company reiterated its full-year 2026 revenue guidance of $54 million to $57 million, expecting 19% to 26% growth over 2025, and anticipates sequential improvement from Q2 to Q4.

Operational highlights include the hiring of a new sales force, CMS approval of a G code for OBL reimbursement, and multiple ongoing and upcoming clinical trials across different indications. Management expressed optimism about future growth, highlighting successful collaboration with CMS and FDA interactions, and a robust pipeline of clinical trials aimed at expanding market reach. Full Transcript OPERATOR (Moderator) Good day and thank you for standing by. Welcome to the TriSalus Life Sciences second quarter 2026 earnings conference call.

At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you'll need to press star one one on your telephone. You will then hear an automated message advising your hand is raised.

To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to turn the conference over to your speaker, Kayleen Parish. Please go ahead.

Kayleen Parish, Investor Relations Good afternoon and thank you all for participating in today's call. Joining me from TriSalus are Mary Szela, President and Chief Executive Officer, David Patience, Chief Financial Officer, and Dr. Richard Marshall, Chief Medical Officer, who will join for Q&A. Earlier today, TriSalus issued a press release announcing financial results for the quarter ended June 30, 2026.

A copy of the press release is available on the Investor Relations section of the Company's website. Before we begin, I'd like to remind you that management will make remarks during this call that include forward-looking statements within the meaning of federal securities laws and that these are being made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements.

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our Forms 10-Q and 10-K on file with the SEC and available on EDGAR, as well as our other periodic filings. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, August 6, 2026.

TriSalus disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise. And with that, I'll turn the call over to Mary. Mary Szela, CEO and President Good afternoon and thank you all for joining us. 4 million.

This reflects sequential and year over year growth as we continue to raise awareness of TRINAV while building clinical evidence and strengthening our commercial foundation. Our growth was driven by the continued execution of our team in the field and was underpinned by progress across our strategic priorities, elevating our commercial team and infrastructure, investing in foundational clinical studies to validate the value of pressure enabled drug delivery, or PEDD, and lastly, innovating and evolving our PEDD technology and portfolio. Before we continue, I want to highlight why what we're doing at TriSalus Life Sciences is so important.

There has been little innovation in catheter assisted oncology drug delivery for the past several decades. While this critical area of patient care has been stagnant, in that same stretch of time we've seen significant leaps forward in therapeutic drug discovery and innovation. We developed the TRINAV system to address this shortfall, enabling interventional radiologists to deliver any therapy to a tumor with enhanced perfusion, tightened precision and greater concentration and, importantly, avoidance of off-target delivery. We remain excited about the opportunity ahead of us as we continue to educate clinicians and patients about the benefits of the TRINAV system.

As we outlined at the beginning of the year, our primary strategic focus has been on making a disciplined, intentional investment into our commercial infrastructure to deepen physician engagement and adoption of TRINAV. As a reminder, we more than doubled our commercial footprint over the first half of the year to better capture the full scope of the opportunity ahead of us. This buildout was deliberate and necessary and we're excited about the caliber of talent that we've brought on board.

We're already seeing positive results from our commercial evolution in the form of ramping engagement and productivity, and we look forward to sharing more of this team's progress over the coming quarters. Turning to a significant development that will expand our commercial opportunity. In July we received notification from CMS of a G code that extends reimbursement of the TRINAV system into the physician office setting, commonly referred to as an office-based lab, or OBL. At its core, moving into the OBL environment is a big win for patients and meaningfully expands the access for our platform once in effect.

As a reminder, TriSalus holds two unique HCPCS C codes established by CMS to specifically reimburse our technology for complex embolization procedures by using a pressure-generating catheter in the outpatient environment, or HOPD, and the ambulatory surgery center, or ASC, sites of service. These codes have been a foundational commercial driver for TriSalus and provide appropriate reimbursement for HOPDs and ASCs. Yet we're seeing treatment for patients with certain liver cancers migrate from these traditional settings into the OBLs. This includes both TACE and TARE procedures.

The rationale for this transition is simple. OBLs offer patients more accessible, community-based settings versus large hospitals, with shorter wait times and more flexible scheduling. For a patient recently diagnosed with liver cancer, the ability to be seen and treated in weeks rather than months can be the difference between a treatable disease and potentially a fatal one. The new G code facilitates patient access to PEDD regardless of the treatment site of care.

This marks a seminal moment for TriSalus as it expands our reach to an increasingly important and growing site of care and gives clinicians more flexibility in where and how they practice. We are genuinely excited about this rule and we want to take a moment to express our gratitude to all of our constituents at CMS with whom we've maintained a positive dialogue over the years. CMS has spent significant energy reviewing our clinical evidence and diligencing the benefits of the TRINAV system. We're excited to continue our engagement with the agency.

S. Food and Drug Administration for TRINAV Advance, which we believe will further expand our set of solutions for our customers. As a reminder, we believe the TRINAV Advance will expand our liver market access by extending PEDD to small distal vessels via microcatheter that are currently not addressable with our existing TRINAV. Moreover, the TRINAV Advance will allow an interventional radiologist to use the microcatheter of their choice while still delivering the full benefit of pressure enabled drug delivery to patients.

Review is running past the MDUFA goal, but we remain in close dialogue with the FDA and hope to receive clearance in the near future. Our second priority has been to demonstrate and validate the value of pressure enabled drug delivery, or PEDD, to drive greater future awareness and adoption. Our team is hard at work on this objective and we now have 11 active studies underway across 27 clinical sites. There's data being generated and evaluated across more than 400 patients who have been treated with TRINAV.

The completed PETER study, the investigator-initiated randomized multi-center trial conducted at Massachusetts General Hospital, evaluates how TRINAV improves the tumor-to-normal ratio in both hepatocellular carcinoma and hypovascular tumors and has been submitted for publication in a peer-reviewed journal. We believe the PETER readout, once published, can be a meaningful catalyst for commercial momentum. The other completed investigator-initiated trial, Trifine 90 at MD Anderson, remains in data review. We look forward to sharing that news with you when it becomes available.

The two retrospective studies we initiated last quarter examining TRINAV-delivered TARE and HCC continue to progress. We're ultimately looking to generate cost-efficient evidence on outcomes in target populations. The findings here will directly inform the design of our larger prospective trials, which we look to initiate in the second half of the year. The PREDICT study at MD Anderson officially launched in the second quarter and is actively enrolling.

This is a prospective study evaluating PEDD's impact in hypovascular tumors, and we expect enrollment to take approximately 12 to 18 months to complete. A second investigator-initiated trial, PRESSURE at Stingenford, will launch open enrollment in the third quarter. This is a randomized study of TRINAV and TARE for liver metastases, comparing tumor-absorbed dose, response rate, and disease control against current standard delivery. Both are designed to generate exactly the kind of prospective head-to-head data that drives clinical adoption at top academic centers.

In addition to PRESSURE, there are additional large studies we're looking to kick off in the second half of 2026. We have a new prospective PEAR study designed specifically to prove TRINAV superiority over a microcatheter. We are evaluating liver metastases response to therapy prospectively, an important consideration for physicians to adopt TRINAV. Second, we're undertaking a multicenter prospective case study in neuroendocrine tumors that is being conducted in collaboration with the University of Pennsylvania, a nationally recognized leader in both liver embolization and the treatment of neuroendocrine tumors.

The trial will compare TRINAV directly to a standard microcatheter in neuroendocrine tumor patients undergoing TACE and is designed to demonstrate TRINAV superiority in this indication. This study is an expansion of an existing pilot study that already showed TRINAV superiority over a microcatheter, giving us high confidence in the hypothesis we're testing at scale. At the recent American Society of Clinical Oncology meeting, AstraZeneca presented exciting data from their EMERALD-3 trial comparing TACE alone to TACE plus AstraZeneca's STRIDE immunotherapy regimen and to TACE plus STRIDE plus the tyrosine kinase inhibitor lenvatinib.

This study showed that both combination arms showed meaningful improvements in progression-free survival, and the still maturing overall survival data looks particularly promising. We believe that these important data will help drive medical oncologists to consider combinations of immunotherapy and liver-directed therapy. This could potentially expand the pool of patients receiving TACE procedures, where we have a particularly strong foothold. Lastly, we're making concerted efforts to expand awareness and appreciation for the value of PEDD with our broader base of stakeholders.

In June, we hosted a webinar to further contextualize the groundbreaking real-world evidence study of PEDD in liver cancer. The webinar highlighted findings from a real-world outcomes study evaluating over 300 million patient lives, including 16,210 embolizations. Of those patients who went through embolization procedures, 1,200 patients were compared, using sophisticated matching, to produce the largest and the most robust PEDD dataset to date. Dr.

Alex Misono, Chief of Interventional Radiology at Hoag Health System in California, joined our webinar as a speaker and reinforced a key finding from the study that I think deserves emphasis. Data showed TRINAV had historically been employed in procedures with the most challenging patients, those who have the highest disease burden, and those with the most complex anatomy. For those patients, TRINAV has proven its clinical benefit, particularly in scenarios where anticipated outcomes were poor. Given the clinical benefits and favorable reimbursement in place, Dr.

Misono also discussed his approach to expanding TRINAV usage with broader utilization across his practice. Additionally, the HEOR data is extremely compelling, with average cost savings in certain procedures of $7,700. We continue to believe that new evidence serves to validate our platform and catalyze adoption within the clinical community. Moving to our third strategic focus, innovating and expanding our indications and portfolio.

Our first focus, liver embolization, is an area of significant opportunity for us, and we remain focused first and foremost on driving growth there. Meanwhile, indications outside of liver, including uterine, genicular, and thyroid artery embolization, present a vast additional growth opportunity. 5 billion. I believe that the continued cultivation of our evidence base to validate our platform as a whole, while executing our clinical strategy across multiple indications and physicians, will expand our footprint materially across liver and non-liver indications alike.

Beyond liver, we're building a pipeline of emerging markets for the PEDD platform: uterine artery embolization, thyroid artery embolization, and genicular artery embolization—meaningful greenfield opportunities for TriSalus—and each one can be a meaningful growth driver going forward. We're in the early innings with these three indications, but the clinical data we're generating is giving us increased confidence that PEDD can redefine treatment and patient outcomes. On uterine artery embolization, momentum continues to build on the strong SIR data we shared last quarter.

The expanded study we approved in Q1 is enrolling well and we remain on track toward our 50-patient target. We continue to advance the design of a prospective trial to more formally evaluate TRINAV's potential to streamline workflow, reduce procedure and fluoroscopy time, and improve outcomes in UAE. One additional note here that I think is worth highlighting is UAE is a procedure that is increasingly being performed in the OBL setting. The G code I discussed earlier has the potential to be a meaningful accelerant for this indication specifically, by removing the reimbursement barrier that has historically limited TRINAV use in physician office-based labs.

We see UAE as one of those earlier beneficiaries of that expanded access and we look forward to updating you on the progress in the coming quarters. On thyroid artery embolization, our PROTECT registry continues to gain momentum across multiple centers, evaluating PEDD for patients with thyroid nodules or goiters who are not candidates for conventional therapy. S. data on TAE in the first quarter of 2027.

We believe that dataset will position PEDD TAE as the leading approach for this procedure, as it is minimally invasive. On genicular artery embolization, we remain focused on executing our clinical strategy. Having concluded our pilot registry, we're actively advancing the formal clinical trial design and look forward to sharing additional updates as that program develops. In total, we view these emerging indications as gateways to significant expansion of our existing addressable market opportunity.

We will continue to vigorously propel forward these trials and clinical initiatives as we secure our foothold in these markets. Finally, I'd like to provide a brief update on our nalatolimod and pancreatic programs. First on nalatolimod, we remain on track to deliver our consolidated PERIO Phase 1 data readout in the second half of 2026, and second, on a broader pancreatic strategy. There's been significant changes in the pancreatic cancer treatment landscape that we're currently evaluating.

We will provide an update on our go-forward pancreatic strategy after we complete that analysis. This last quarter was a period of continued focus and execution for TriSalus as we solidified our foundation for future growth. We have a fully deployed, meaningfully expanded commercial organization that is ramping toward its full productivity potential.