TriSalus cuts 2026 revenue outlook to $46–48 million after sales slowdown
Key Facts
TriSalus Life Sciences cut its fiscal 2026 revenue outlook to $46–48 million, equivalent to growth of about 2% to 6% compared with 2025 revenue, according to the company’s filing with the U.S. Securities and Exchange Commission. The revision came after the company maintained its annual guidance at $54–57 million in its second-quarter results. Management said the updated range reflects slower-than-expected gains in productivity from its expanded sales force and an accelerated shift toward highly selective Y90 procedures in small, distal vessels. It said the TriNav Advance device was unavailable to address this shift fully before receiving regulatory clearance. The company’s shares fell 26.55% in the November 10 session to $2.365 from $3.22, according to the earnings call report.
The company posted revenue of $12.9 million for the three months ended September 30, 2026, up 11.3% from the same period a year earlier. It attributed the increase mainly to higher sales of TriNav system units. That puts quarterly sales growth alongside a cut to the annual outlook, as management expects commercial scaling factors and procedure mix to constrain total revenue during the rest of the year. Revenue in 2025 was $45.151 million, up 53.4% year over year, making the new 2026 range indicative of much slower growth than the prior year’s pace. The guidance shows the company expects a limited increase over its 2025 revenue base despite TriNav sales growth in the third quarter.
Gross margin improved to 86.2% in the third quarter from 83.5% in the corresponding period of 2025. The company said the improvement was mainly due to a lower cost per TriNav unit. At the same time, operating losses were $7.7 million, compared with losses of $9.0 million a year earlier. The company linked the narrower losses to improved margins and lower research and development and administrative expenses. This was partly offset by higher sales and marketing expenses, reflecting the cost of expanding the commercial team, which has yet to reach the productivity management expected.
The chief executive said the company more than doubled the size of its commercial presence in the first half of 2026, but team productivity increased slightly more slowly than expected. She added that the launch of TriNav Advance and expanded access to office-based labs through procedure code G0577 are among the foundations for future growth. The U.S. Food and Drug Administration granted the device 510(k) clearance on September 21, 2026, finding it substantially equivalent to legally marketed predicate devices and eligible for marketing under general controls. The device is used in image-guided vascular procedures to deliver contrast agents and therapeutic agents to selected sites in the peripheral vasculature. Management said the new guidance reflects the device’s unavailability when the shift to highly selective Y90 procedures accelerated, placing commercial expansion and adapting the product for this use among current execution challenges.
The national Medicare reimbursement rate for C8004 procedures is scheduled to rise from about $11,794 to about $20,910 per procedure starting January 1, 2027. The Centers for Medicare & Medicaid Services also set national office-based reimbursement of about $13,800 per G0577 procedure, effective on the same date. The new rates come as the company seeks to expand access to office-based labs, which management linked to a growth pathway for its products. The inclusion of office-based reimbursement for this procedure provides financial context for the expansion efforts cited by the company, while its effect on revenue remains dependent on procedure adoption and broader use. The company confirmed that it had met the threshold required to conduct an interim analysis of the PROTECT registry for thyroid artery embolization.
The company expects to present the first U.S. multicenter data on thyroid artery embolization in the first quarter of 2027. Cash and cash equivalents totaled $41.1 million on September 30, 2026, after the company raised a total of $46.0 million through an equity offering in the first quarter. The reported liquidity provides a picture of available cash resources alongside the expansion of the commercial team and development of device-use pathways. In the near term, management faces the task of raising sales-force productivity and keeping pace with the shift to highly selective procedures, while the new Medicare rates and PROTECT registry data provide defined milestones in 2027. The updated guidance focuses on revenue for the current fiscal year, while the later developments are elements the company said support its future growth path.