TriSalus Life Sciences (NASDAQ:TLSI) reported second-quarter revenue of $11.4 million, up 1.7% from $11.2 million a year earlier, as demand for its TriNav pressure-enabled drug delivery system increased. The company reiterated its full-year 2026 revenue outlook of $54 million to $57 million, representing projected growth of 19% to 26% over 2025.
President and Chief Executive Officer Mary Szela said the quarter reflected progress in expanding the company’s commercial infrastructure, building clinical evidence for pressure-enabled drug delivery, or PEDD, and broadening the potential uses of its technology. TriSalus more than doubled its commercial footprint during the first half of the year, with the hiring initiative beginning in February and all new representatives in place by April.
Office-Based Lab Reimbursement Opportunity
A key development during the quarter was notification from the Centers for Medicare & Medicaid Services regarding a G-code intended to extend reimbursement for TriNav into physician office settings, known as office-based labs, or OBLs. TriSalus already has two HCPCS C codes for complex embolization procedures using pressure-generating catheters in hospital outpatient departments and ambulatory surgery centers.
Szela said the new code could support access to TriNav as some liver cancer treatments migrate from hospitals into office-based settings. She cited shorter wait times and more flexible scheduling as potential advantages for patients receiving treatment in OBLs.
The company sees liver embolization as an initial opportunity in the setting, along with uterine, prostate and genicular artery embolization procedures. Szela said TriSalus is still evaluating its plans but initially believes its existing sales representatives can cover most of the opportunity because many interventional radiologists practice across hospital and office-based settings.
Chief Medical Officer Dr. Richard Marshall said most interventional radiologists maintain broad practices and commonly perform a range of procedures, including Y90 radioembolization, transarterial chemoembolization, and uterine artery embolization. He added that physicians familiar with TriNav’s use in liver procedures have begun applying it in uterine artery embolization, helping inform the company’s investment in that indication.
Clinical Programs and Product Development
TriSalus said it has 11 active clinical studies across 27 sites, involving data from more than 400 patients treated with TriNav. The completed PETER study at Massachusetts General Hospital, a randomized multicenter trial evaluating tumor-to-normal ratio in hepatocellular carcinoma and hypovascular tumors, has been submitted for publication in a peer-reviewed journal. Another completed investigator-initiated study, TRI590 at MD Anderson, remains under data review.
The PREDICTT study at MD Anderson began enrolling during the second quarter and is evaluating PEDD in hypovascular tumors. TriSalus expects enrollment to take approximately 12 to 18 months. A separate randomized study called PRESSURE, at Stanford, is expected to open enrollment in the third quarter. That study will compare TriNav and radioembolization treatment with standard delivery for liver metastases.
The company also plans to begin additional prospective studies during the second half of 2026, including a radioembolization study comparing TriNav with a microcatheter and a multicenter chemoembolization study in neuroendocrine tumors in collaboration with the University of Pennsylvania.
Beyond liver procedures, TriSalus is advancing studies in uterine artery embolization, thyroid artery embolization and genicular artery embolization. The uterine artery embolization study remains on track toward a 50-patient target, while the company’s PROTECT thyroid registry has reached the enrollment cutoff for an interim analysis. TriSalus expects to report initial multicenter U.S. thyroid artery embolization data in the first quarter of 2027.
TriSalus also continues to anticipate near-term Food and Drug Administration 510(k) clearance for TriNav Advance. The company said the device is designed to enable PEDD in smaller distal vessels through use of a microcatheter selected by the physician. FDA review has extended beyond its MDUFA goal date, according to Szela.
Expenses, Margins and Outlook
Chief Financial Officer David Patience said gross margin improved to 86.8% from 83.9% in the prior-year quarter, driven by lower average TriNav unit costs and manufacturing improvements. Research and development expense declined to about $3.1 million from $3.7 million, while general and administrative expense fell to about $5.1 million from $5.9 million.
Sales and marketing expense increased to $11.4 million from $7.2 million, reflecting costs associated with recruiting, onboarding and training the expanded commercial organization. As a result, adjusted EBITDA loss widened to about $7.1 million from $5.3 million in the year-earlier period.
TriSalus ended the quarter with approximately $46.3 million in cash, which Patience said the company believes is sufficient to fund its strategic growth plan. Management expects revenue growth to improve sequentially in the third quarter and strengthen further in the fourth quarter. It also expects sales and marketing expense to decline sequentially in the third and fourth quarters as costs tied to the first-half sales-force expansion recede.
The company remains on track to provide consolidated Phase I data from its PERIO study of nelitolimod in the second half of 2026. Szela said TriSalus is also evaluating changes in the pancreatic cancer treatment landscape and will provide an update on its broader pancreatic strategy after completing that assessment.
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.
