TriSalus Life Sciences (NASDAQ:TLSI) reported slightly lower first-quarter revenue and reduced its full-year 2026 revenue outlook, citing disruption from a broad commercial reorganization and a delayed FDA review for its next-generation TriNav Advance device.
President and Chief Executive Officer Mary Szela said the company’s first-quarter results reflected the “deliberate cost of a build-out phase” as TriSalus expanded and realigned its sales organization to support growth in liver embolization and new applications for its Pressure-Enabled Drug Delivery, or PEDD, platform.
Revenue Slips as Sales Force Expansion Weighs on Quarter
For the quarter ended March 31, 2026, TriSalus reported revenue of $8.9 million, compared with $9.2 million in the prior-year period. Chief Financial Officer David Patience said the decline was due to the transition tied to the expanded commercial organization.
Gross margin improved to 86% from 84% a year earlier, driven by lower average unit costs on TriNav and continued manufacturing improvements. Research and development expenses rose to $3.2 million from $3 million, while sales and marketing expenses increased to $7.4 million from $6.7 million as the company added headcount, training and territory development costs. General and administrative expenses were $5.4 million, up from $5.2 million.
The company reported a net operating loss of $8.4 million, compared with a $7.3 million loss in the prior-year period. Adjusted EBITDA loss was approximately $5.8 million, compared with $5.5 million in the first quarter of 2025. TriSalus ended the quarter with $56.6 million in cash and cash equivalents.
Patience said the company’s gross margins remained “durable in the mid-80s” and that its cash position “fully funds” the strategic growth plan.
Guidance Cut on Commercial Transition and TriNav Advance Delay
TriSalus revised its full-year 2026 revenue guidance to a range of $54 million to $57 million. Szela said the revision reflected both lower first-quarter revenue from the commercial expansion and delayed FDA clearance timing for TriNav Advance, a next-generation device intended to extend PEDD capability to small distal vessels through a microcatheter.
According to Szela, FDA review of TriNav Advance is running about five months beyond the 30-day MDUFA review goal. The company remains in active dialogue with the agency and still expects clearance in the second half of the year, but it removed TriNav Advance revenue expectations from its second-half forecast.
Szela said TriNav Advance remains important to the company’s product strategy because it would allow interventional radiologists to access PEDD benefits while using the microcatheter of their choice.
Commercial Organization More Than Doubled
TriSalus said its expanded sales organization was largely in place as of May. Szela said the company had added commercial leadership, field management, sales representatives and clinical specialists after territories had grown beyond what existing representatives and managers could effectively cover.
Chris Staudt recently joined the company as senior vice president of sales and commercial operations. Szela said Staudt brings more than 20 years of commercial leadership experience from companies including Roche, Ventana, Luminex and Accelerate Diagnostics.
During the question-and-answer portion of the call, Szela said roughly 60% of territories where representative-to-physician relationships remained intact performed in line with expectations. In the remaining 40%, the company changed both the representative-to-physician and representative-to-manager relationships, which created disruption.
“We are very comfortable that there’s been really no fundamental change in demand,” Szela said. She added that the company is now “a little bit above” its prior plan to double the organization and expects month-over-month growth through the rest of the year as new representatives ramp.
Patience said TriSalus expects only a “marginal sequential gain” in the second quarter as representatives come out of training, with more meaningful progress anticipated in the third and fourth quarters.
PEDD Real-World Evidence Study Highlights Clinical and Cost Impact
TriSalus also announced publication of what Szela called the largest real-world evidence study of PEDD conducted to date. The study included 603 PEDD patients matched against more than 16,210 non-PEDD patients from a claims database covering 96% of U.S. payers and spanning January 2020 through March 2024.
The cohort included 515 TARE patients and 88 TACE patients. Szela said the analysis used a two-stage matching design combining Coarsened Exact Matching and propensity score matching.
According to the company, PEDD-treated patients showed statistically significant improvements across several measures, including lower post-procedure fatigue, lower lymphopenia at high-adopter centers and reduced 30-day inpatient admissions in the TACE subgroup. Szela said PEDD procedures delivered about 48% more doxorubicin per procedure and cut 30-day inpatient admissions in TACE patients to 8%, compared with 20.5% without PEDD.
The study also found approximately $7,700 in per-patient cost avoidance across the 603-patient PEDD cohort, including roughly $3,100 from fewer inpatient stays and $4,600 from fewer post-procedure complications, according to Szela.
Medical Director Dr. Richard Marshall said the real-world nature of the data was important for interventional radiology. “This is actually what’s happening in the U.S.,” Marshall said. He added that the study helps physicians understand the economic value that procedures bring to patient care.
Pipeline Updates Include New Applications and Nelitolimod
TriSalus said it now has 10 active studies underway across 24 clinical sites, generating data on more than 400 TriNav-treated patients. Two prospective investigator-initiated trials are expected to begin enrollment this quarter: PRESSURE at Stanford, evaluating TriNav and TARE for liver metastases, and PREDICT at MD Anderson, evaluating PEDD in hypovascular tumors.
The company is also preparing publication submissions for two completed investigator-initiated trials, PETER at Massachusetts General Hospital and TRIFY90 at MD Anderson. Szela said those readouts could support second-half commercial momentum.
Beyond liver applications, TriSalus highlighted work in uterine artery embolization, thyroid artery embolization and genicular artery embolization. Szela said these indications collectively represent a U.S. addressable market of approximately $2.5 billion.
For nelitolimod, TriSalus said it remains on track to deliver a consolidated PERIO Phase 1 readout in the early second half of 2026. Szela said the timing is not driven by a safety signal, efficacy concern or change in strategic priorities. She said the company intends to advance nelitolimod and its broader pancreatic program through a partnership structure while maintaining capital discipline.
About TriSalus Life Sciences (NASDAQ:TLSI)
TriSalus Life Sciences, Inc is a clinical-stage biotechnology company focused on the development and commercialization of non-invasive drug–device combination therapies for oncology applications. Leveraging proprietary electroporation and ultrasound platforms, the company aims to enhance the localized delivery and efficacy of established chemotherapeutic agents while reducing systemic toxicity. Its lead programs target hard-to-treat head and neck cancers, where improved tumor control and patient tolerability remain significant unmet needs.
The company’s pipeline comprises investigational product candidates in early and mid-stage clinical trials, including studies that combine its electrochemotherapy platform with radiation therapy and immuno-oncology agents.
