Which new indications will be most impacted by the new office-based lab (OBL) reimbursement, and when do you plan to allocate more sales and marketing resources to capitalize on these opportunities?

The OBL reimbursement will primarily benefit liver embolization patients who are migrating from hospitals to OBLs, and also other embolization procedures like uterine, prostate, and genicular artery embolization. The G-code came earlier than anticipated, and planning is currently underway to leverage this expanded access. Uterine artery embolization is expected to be an early beneficiary. “But there's also a lot of other embolization procedures where -- uterine artery embolization, prostate artery embolization, genicular artery embolization, uterine artery embolization. These are a lot of those procedures that are done in that site of care. And so now we'll have the opportunity to have TriNav.”

Is there overlap in call points between the current liver market and adjacent markets, and can the existing sales force leverage their experience in liver for these new indications?

There is significant overlap in call points. Many interventional radiologists work in both hospital and OBL settings and perform a broad range of procedures, including Y90, TACE, and uterine artery embolization. The current sales force is expected to handle the majority of this expansion, as physicians who understand TriNav's value in one area often apply it to others. No incremental sales resources are initially anticipated. “So the overlap here is really quite broad. So a physician such as myself and many of the people that I know, will perform Y90, TACE, uterine artery embolization. They'll also be -- the same applies to biopsies and drainages. You're kind of there in a hospital-based practice to do everything that comes in. So the call point is really the same. There's not a whole lot of difference between physicians.”

TLSI

TriSalus Life Sciences (TLSI) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 6, 2026

Source: earnings call transcript

Executive summary

TriSalus Life Sciences Q2 FY26 — Strong Revenue Growth and Expanded Reimbursement

TriSalus delivered a strong second quarter, driven by commercial expansion and progress in clinical evidence generation for its TriNav system. The company secured a significant G-code from CMS, expanding reimbursement into office-based labs, which is expected to accelerate adoption across liver and non-liver indications. While investments in commercial infrastructure led to increased losses, management reiterated full-year revenue guidance, expressing confidence in future growth and disciplined cost control.

Highlights

Total revenue exceeded $11.4 million, reflecting sequential and year-over-year growth.
Gross margin improved to 86.8% in Q2 FY26, up from 83.9% in the prior year period.
CMS issued a G-code in July, extending TriNav system reimbursement into physician office settings (OBLs), significantly expanding market access.
Full-year 2026 revenue guidance was reiterated at $54 million to $57 million, representing 19% to 26% growth over full year 2025.

Concerns

Adjusted EBITDA loss increased to $7.1 million in Q2 FY26, compared to $5.3 million in Q2 FY25, due to investments in commercial expansion.
TriNav Advance 510(k) clearance is running past the MDUFA goal, though the company remains in close dialogue with the FDA.
Sales and marketing expenses rose to $11.4 million in Q2 FY26 from $7.2 million in Q2 FY25, reflecting deliberate investment in commercial footprint expansion.

Guidance & targets

Category	Target	Timeline	Confidence
Full-year revenue	$54 million to $57 million high materiality	FY26	High
Growth trajectory	Sequential improvement in growth from Q2 to Q3, followed by a stronger Q4 medium materiality	Q3 FY26, Q4 FY26	High
Sales and marketing expenses	Decline sequentially in the third and fourth quarter medium materiality	Q3 FY26, Q4 FY26	High
Nelitolimod PERIO Phase I data readout	Consolidated data readout medium materiality	H2 2026 · FY26	High
PROTECT registry (TAE) data delivery	First multicenter U.S. data medium materiality	Q1 · FY27	High
PREDICTT study enrollment completion	Approximately 12 to 18 months to complete low materiality	Next 12-18 months · FY27	Medium
PRESSURE study open enrollment	Launch open enrollment low materiality	Q3 · FY26	High
PAIR study kick-off	Kick off low materiality	H2 2026 · FY26	High
TACE study in neuroendocrine tumors kick-off	Kick off low materiality	H2 2026 · FY26	High

Product announcements

Product	Type	Timeline	Details
TriNav Advance	update	near term

Risks & headwinds

TriNav Advance 510(k) clearance delay Near term

Review is running past the MDUFA goal.

Mitigation:Remaining in close dialogue with the FDA and hoping to receive clearance in the near future.

Increased Adjusted EBITDA loss Q2 FY26

$7.1 million loss in Q2 FY26 compared to $5.3 million in Q2 FY25.

Mitigation:This reflects deliberate investment in the expanded sales organization for long-term sustainable growth, with sales and marketing expenses expected to decline sequentially in Q3 and Q4.

Changes in pancreatic cancer treatment landscape Current

Significant changes

Mitigation:Currently evaluating the changes and will provide an update on the go-forward pancreatic strategy after completing the analysis.

What to watch in Q3 FY26

TriNav Advance 510(k) clearance

Near term

Current Review running past MDUFA goal

Target Clearance

Why it matters

Expands liver market access to small distal vessels and allows microcatheter choice, crucial for market penetration.

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.

Find out whether TLSI delivers this. Inve re-checks your case every morning.

Q&A highlights

Can you provide more details on the productivity improvement of the new sales reps hired in Q1, their launch trajectory, and their expected impact in Q3 and Q4?

The new sales reps, hired by April, now have two quarters of experience, and their contribution is expected to increase substantially in the second half of the year. Management is pleased with the caliber of talent and confirmed that productivity is on track with internal models, with many reps exceeding internal metrics.

“So now you're seeing our reps in the back half of the year, they have 2 quarters under their belt. And we're starting to see that contribution increase pretty substantially in the back half of the year.”

asked by Frank Takkinen · answered by Mary Szela

2 min read 5 chapters

Detailed narrative

Commercial Expansion & OBL Reimbursement

TriSalus significantly expanded its commercial footprint in the first half of the year, more than doubling its sales force, which is now ramping towards full productivity. This expansion is already yielding positive results in terms of engagement and productivity. A key development is the new CMS G-code, effective July, which extends reimbursement for the TriNav system into physician office settings (OBLs).

This is expected to meaningfully expand patient access and clinician flexibility, particularly for liver embolization procedures and other emerging indications like uterine artery embolization, which are increasingly performed in OBLs.

Clinical Evidence Generation

The company is actively generating clinical evidence with 11 active studies across 27 sites, involving over 400 TriNav-treated patients. The PEDIR study, evaluating TriNav's improvement in tumor-to-normal ratio in HCC and hypovascular tumors, has been submitted for peer-reviewed publication. New prospective trials, PREDICTT (hypovascular tumors) and PRESSURE (liver metastases), are either actively enrolling or launching in Q3 FY26, designed to provide head-to-head data to drive clinical adoption.

Additional large studies, PAIR and a TACE study in neuroendocrine tumors, are planned for kick-off in H2 2026.

Pipeline Expansion Beyond Liver

TriSalus is pursuing significant growth opportunities in non-liver indications, including uterine, thyroid, and genicular artery embolization, which collectively represent an addressable market of approximately $2.5 billion in the U.S. Momentum is building in uterine artery embolization with an expanded study enrolling well, and the PROTECT registry for thyroid artery embolization is on track to deliver multicenter U.S. data in Q1 2027.

The new OBL G-code is anticipated to be a significant accelerant for these emerging indications by removing reimbursement barriers.

Nelitolimod & Pancreatic Programs

The consolidated PERIO Phase I data readout for nelitolimod is on track for the second half of 2026. Separately, TriSalus is evaluating significant changes in the pancreatic cancer treatment landscape to refine its broader pancreatic strategy. An update on the go-forward strategy will be provided after this analysis is complete.

Real-World Evidence & Cost Savings

A recent webinar highlighted compelling real-world evidence from a study evaluating over 300 million patient lives, including 1,200 matched patients treated with PEDD. The data demonstrated TriNav's clinical benefit in challenging patients with high disease burden and complex anatomy, particularly in scenarios with poor anticipated outcomes.

Health economics and outcomes research (HEOR) data also showed average cost savings of $7,700 in certain procedures, further validating the platform and catalyzing adoption.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.