TriSalus Initiates PREDICTT Clinical Trial for Liver Tumors
Written by Emily J. Thompson, Senior Investment Analyst
Updated: May 04 2026
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Should l Buy TLSI?
Source: Newsfilter
- Clinical Trial Launch: TriSalus Life Sciences has announced the initiation of the PREDICTT clinical trial, aimed at evaluating its innovative Pressure-Enabled Drug Delivery™ (PEDD™) technology in liver tumor patients, with plans to enroll approximately 20 patients, thereby advancing precision in liver cancer treatment.
- Technological Innovation: The trial will utilize the TriNav® Infusion System in conjunction with Y90 radioembolization therapy, focusing on assessing changes in CT-based tumor-to-normal liver enhancement ratios, with the goal of optimizing drug delivery to maximize tumor dose while minimizing exposure to healthy liver tissue.
- Strengthened Collaboration: The launch of the PREDICTT trial underscores the ongoing collaboration between TriSalus and The University of Texas MD Anderson Cancer Center, as both parties are committed to optimizing locoregional therapies through advanced delivery technologies, which could redefine the implementation of Y90 therapies.
- Future Outlook: TriSalus plans to explore partnership opportunities for further development of its PEDD technology and investigational immunotherapy candidate nelitolimod after completing data from several phase 1 clinical trials, aiming to enhance patient treatment outcomes.
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Analyst Views on TLSI
Wall Street analysts forecast TLSI stock price to rise
6 Analyst Rating
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 4.560
Low
10.00
Averages
11.92
High
16.00
Current: 4.560
Low
10.00
Averages
11.92
High
16.00
About TLSI
TriSalus Life Sciences, Inc. is an oncology-focused medical technology company. It is seeking to transform outcomes for patients with solid tumors by integrating its delivery technology with standard-of-care therapies, and with its investigational immunotherapeutic, nelitolimod, a class C Toll-like receptor 9 agonist, for a range of different therapeutic and technological applications. Its delivery method, Pressure-Enabled Drug Delivery (PEDD), modulates pressure and flow within blood vessels to improve intravascular therapeutic delivery into tumors, thereby increasing the likelihood of tumor response in comparison to conventional delivery technologies. Its on-market TriNav Infusion System using PEDD technology, is being used for interventional radiology procedures, commonly transarterial radioembolization (TARE) and transarterial chemoembolization (TACE) in patients with primary liver cancer or in patients with liver metastases. TriNav is a device with a novel (PEDD) delivery method.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
TriSalus Life Sciences Q1 2026 Earnings Call Insights
- Guidance Revision: TriSalus has revised its full-year 2026 revenue guidance to a range of $54 million to $57 million, primarily due to lower-than-expected Q1 revenues and delays in FDA clearance for TriNav Advance, indicating challenges faced during the expansion of its sales organization.
- Sales Organization Restructuring: CEO Mary Szela noted that while the new sales organization is largely in place, 60% of territories remained unaffected; however, the 40% that underwent critical relationship changes experienced sales disruptions, which are expected to impact short-term performance.
- Clinical Evidence Publication: The company released significant real-world evidence on PEDD, demonstrating approximately $7,700 in cost avoidance per patient, highlighting the potential value of this new data in supporting standard care and inclusion in NCCN guidelines, which could positively influence future sales.
- Financial Performance Overview: Q1 revenue stood at $8.9 million with a gross margin of 86%, and despite an operating loss of $8.4 million, the company reported cash and cash equivalents of $56.6 million, sufficient to fund its strategic growth plan.
See More
TriSalus Life Sciences Q1 Earnings Analysis
- Earnings Highlights: TriSalus Life Sciences reported a Q1 GAAP EPS of $0.03, beating expectations by $0.19, indicating a slight improvement in profitability.
- Revenue Performance: Despite the EPS beat, the company reported revenue of $8.9 million, a 3.3% year-over-year decline, missing the target by $1.54 million, reflecting weak market demand.
- Adjusted EBITDA Losses: The adjusted EBITDA loss was $5.8 million, an increase from $5.5 million in the same period of 2025, primarily driven by higher stock-based compensation and increased operating expenses, indicating challenges in cost management.
- Future Outlook: TriSalus reaffirms its revenue guidance of $60 million to $62 million for 2026, and despite current financial struggles, the company is expanding its PEDD portfolio, demonstrating confidence in future growth.
See More
TriSalus Initiates PREDICTT Clinical Trial for Liver Tumors
- Clinical Trial Launch: TriSalus Life Sciences has announced the initiation of the PREDICTT clinical trial, aimed at evaluating its innovative Pressure-Enabled Drug Delivery™ (PEDD™) technology in liver tumor patients, with plans to enroll approximately 20 patients, thereby advancing precision in liver cancer treatment.
- Technological Innovation: The trial will utilize the TriNav® Infusion System in conjunction with Y90 radioembolization therapy, focusing on assessing changes in CT-based tumor-to-normal liver enhancement ratios, with the goal of optimizing drug delivery to maximize tumor dose while minimizing exposure to healthy liver tissue.
- Strengthened Collaboration: The launch of the PREDICTT trial underscores the ongoing collaboration between TriSalus and The University of Texas MD Anderson Cancer Center, as both parties are committed to optimizing locoregional therapies through advanced delivery technologies, which could redefine the implementation of Y90 therapies.
- Future Outlook: TriSalus plans to explore partnership opportunities for further development of its PEDD technology and investigational immunotherapy candidate nelitolimod after completing data from several phase 1 clinical trials, aiming to enhance patient treatment outcomes.
See More
TriSalus Appoints New Chief Medical Officer
- Executive Change: TriSalus Life Sciences announced the appointment of Richard Marshall as Chief Medical Officer, effective June 29, 2026, transitioning from his current role as Medical Director since January 2025, indicating the company's ongoing development in medical leadership.
- Professional Background: Marshall is an interventional radiologist with extensive experience in interventional oncology, hepatobiliary interventions, and trauma care, which may enhance TriSalus's expertise in these medical fields, thereby improving the company's competitive position in the market.
- Stock Price Movement: TriSalus Life Sciences shares closed at $3.98 on Monday, down 2.45% from the previous trading day, reflecting market caution regarding the executive change, which could impact investor confidence.
- Future Outlook: With Marshall's appointment, TriSalus may benefit in future medical innovations and strategic developments, particularly in further expanding and optimizing its core business areas.
See More
TriSalus Appoints New Chief Medical Officer
- Leadership Change: TriSalus Life Sciences announces the appointment of Dr. Richard Marshall as Chief Medical Officer effective June 29, 2026, transitioning from his role as Medical Director since January 2025, which is expected to enhance the company's medical strategy and clinical leadership.
- Extensive Clinical Experience: Dr. Marshall brings a wealth of experience in interventional radiology and oncology, having developed Louisiana's first Interventional Radiology Residency at LSU and served on faculty at Tulane University, showcasing his potential to drive medical innovation.
- Platform Development: Under Dr. Marshall's leadership, TriSalus aims to advance its Pressure-Enabled Drug Delivery (PEDD) platform's clinical and economic advantage data, targeting improved treatment outcomes for patients with solid tumors and enhancing the company's competitive position in oncology.
- Clear Strategic Goals: Dr. Marshall expressed his commitment to addressing significant challenges in liver and pancreatic tumor treatments, leveraging the potential of the PEDD approach to provide safer and more effective therapies, thereby solidifying TriSalus's leadership in cancer treatment technologies.
See More
TriSalus Publishes Liver Tumor Research Findings
- Drug Delivery Innovation: TriSalus's research indicates that the Pressure-Enabled Drug Delivery™ (PEDD™) technology using the TriNav® Infusion System significantly enhances the intratumoral distribution of nelitolimod in liver tumor models compared to conventional microcatheter delivery, potentially transforming tumor treatment strategies.
- Enhanced Immune Activity: The application of PEDD was associated with reduced levels of immunosuppressive myeloid-derived suppressor cells (MDSCs) and increased infiltration of cytotoxic CD8+ T cells within the tumor microenvironment, demonstrating the technology's potential in activating local immune responses.
- Tumor Growth Suppression: In murine liver metastasis models, nelitolimod delivered via PEDD significantly reduced tumor growth rates, indicating the effectiveness of this technology in enhancing immunotherapy outcomes.
- Strategic Implications: The findings support TriSalus's strategy of combining PEDD with locoregional immunotherapy, potentially offering new treatment options for patients with difficult-to-treat solid tumors and further solidifying the company's leadership position in oncology.
See More
TriSalus Life Sciences Q1 2026 Earnings Call Insights
- Guidance Revision: TriSalus has revised its full-year 2026 revenue guidance to a range of $54 million to $57 million, primarily due to lower-than-expected Q1 revenues and delays in FDA clearance for TriNav Advance, indicating challenges faced during the expansion of its sales organization.
- Sales Organization Restructuring: CEO Mary Szela noted that while the new sales organization is largely in place, 60% of territories remained unaffected; however, the 40% that underwent critical relationship changes experienced sales disruptions, which are expected to impact short-term performance.
- Clinical Evidence Publication: The company released significant real-world evidence on PEDD, demonstrating approximately $7,700 in cost avoidance per patient, highlighting the potential value of this new data in supporting standard care and inclusion in NCCN guidelines, which could positively influence future sales.
- Financial Performance Overview: Q1 revenue stood at $8.9 million with a gross margin of 86%, and despite an operating loss of $8.4 million, the company reported cash and cash equivalents of $56.6 million, sufficient to fund its strategic growth plan.
See More
TriSalus Life Sciences Q1 Earnings Analysis
- Earnings Highlights: TriSalus Life Sciences reported a Q1 GAAP EPS of $0.03, beating expectations by $0.19, indicating a slight improvement in profitability.
- Revenue Performance: Despite the EPS beat, the company reported revenue of $8.9 million, a 3.3% year-over-year decline, missing the target by $1.54 million, reflecting weak market demand.
- Adjusted EBITDA Losses: The adjusted EBITDA loss was $5.8 million, an increase from $5.5 million in the same period of 2025, primarily driven by higher stock-based compensation and increased operating expenses, indicating challenges in cost management.
- Future Outlook: TriSalus reaffirms its revenue guidance of $60 million to $62 million for 2026, and despite current financial struggles, the company is expanding its PEDD portfolio, demonstrating confidence in future growth.
See More
TriSalus Initiates PREDICTT Clinical Trial for Liver Tumors
- Clinical Trial Launch: TriSalus Life Sciences has announced the initiation of the PREDICTT clinical trial, aimed at evaluating its innovative Pressure-Enabled Drug Delivery™ (PEDD™) technology in liver tumor patients, with plans to enroll approximately 20 patients, thereby advancing precision in liver cancer treatment.
- Technological Innovation: The trial will utilize the TriNav® Infusion System in conjunction with Y90 radioembolization therapy, focusing on assessing changes in CT-based tumor-to-normal liver enhancement ratios, with the goal of optimizing drug delivery to maximize tumor dose while minimizing exposure to healthy liver tissue.
- Strengthened Collaboration: The launch of the PREDICTT trial underscores the ongoing collaboration between TriSalus and The University of Texas MD Anderson Cancer Center, as both parties are committed to optimizing locoregional therapies through advanced delivery technologies, which could redefine the implementation of Y90 therapies.
- Future Outlook: TriSalus plans to explore partnership opportunities for further development of its PEDD technology and investigational immunotherapy candidate nelitolimod after completing data from several phase 1 clinical trials, aiming to enhance patient treatment outcomes.
See More
TriSalus Appoints New Chief Medical Officer
- Executive Change: TriSalus Life Sciences announced the appointment of Richard Marshall as Chief Medical Officer, effective June 29, 2026, transitioning from his current role as Medical Director since January 2025, indicating the company's ongoing development in medical leadership.
- Professional Background: Marshall is an interventional radiologist with extensive experience in interventional oncology, hepatobiliary interventions, and trauma care, which may enhance TriSalus's expertise in these medical fields, thereby improving the company's competitive position in the market.
- Stock Price Movement: TriSalus Life Sciences shares closed at $3.98 on Monday, down 2.45% from the previous trading day, reflecting market caution regarding the executive change, which could impact investor confidence.
- Future Outlook: With Marshall's appointment, TriSalus may benefit in future medical innovations and strategic developments, particularly in further expanding and optimizing its core business areas.
See More
TriSalus Appoints New Chief Medical Officer
- Leadership Change: TriSalus Life Sciences announces the appointment of Dr. Richard Marshall as Chief Medical Officer effective June 29, 2026, transitioning from his role as Medical Director since January 2025, which is expected to enhance the company's medical strategy and clinical leadership.
- Extensive Clinical Experience: Dr. Marshall brings a wealth of experience in interventional radiology and oncology, having developed Louisiana's first Interventional Radiology Residency at LSU and served on faculty at Tulane University, showcasing his potential to drive medical innovation.
- Platform Development: Under Dr. Marshall's leadership, TriSalus aims to advance its Pressure-Enabled Drug Delivery (PEDD) platform's clinical and economic advantage data, targeting improved treatment outcomes for patients with solid tumors and enhancing the company's competitive position in oncology.
- Clear Strategic Goals: Dr. Marshall expressed his commitment to addressing significant challenges in liver and pancreatic tumor treatments, leveraging the potential of the PEDD approach to provide safer and more effective therapies, thereby solidifying TriSalus's leadership in cancer treatment technologies.
See More
TriSalus Publishes Liver Tumor Research Findings
- Drug Delivery Innovation: TriSalus's research indicates that the Pressure-Enabled Drug Delivery™ (PEDD™) technology using the TriNav® Infusion System significantly enhances the intratumoral distribution of nelitolimod in liver tumor models compared to conventional microcatheter delivery, potentially transforming tumor treatment strategies.
- Enhanced Immune Activity: The application of PEDD was associated with reduced levels of immunosuppressive myeloid-derived suppressor cells (MDSCs) and increased infiltration of cytotoxic CD8+ T cells within the tumor microenvironment, demonstrating the technology's potential in activating local immune responses.
- Tumor Growth Suppression: In murine liver metastasis models, nelitolimod delivered via PEDD significantly reduced tumor growth rates, indicating the effectiveness of this technology in enhancing immunotherapy outcomes.
- Strategic Implications: The findings support TriSalus's strategy of combining PEDD with locoregional immunotherapy, potentially offering new treatment options for patients with difficult-to-treat solid tumors and further solidifying the company's leadership position in oncology.
See More
