For many cancer patients, the biggest challenge is not always finding a treatment. Sometimes, it is making sure that treatment reaches the tumor effectively. Doctors have long known that solid tumors can create physical barriers that prevent therapies from penetrating deep into cancer tissue. This problem is especially common in liver and pancreatic cancers, two of the most difficult forms of cancer to treat. Even promising therapies can struggle to reach their intended target, limiting their impact on patient outcomes.
TriSalus Life Sciences was founded with a mission to address this challenge. Instead of focusing solely on developing new drugs, the company set out to improve how therapies are delivered to tumors. Through its Smart Drug Delivery Systems and proprietary Pressure-Enabled Drug Delivery (PEDD) technology, TriSalus is working to transform treatment for patients with liver and pancreatic tumors. Today, the company combines innovative delivery devices with immunotherapy research in an effort to improve therapeutic effectiveness while reducing unnecessary exposure to healthy tissue.
Addressing a Critical Barrier in Cancer Care
One of the major obstacles in treating solid tumors is intratumoral pressure. As tumors grow, they often develop high internal pressure that acts as a barrier against incoming therapies. This pressure can limit the ability of drugs to penetrate tumor tissue, reducing treatment effectiveness. TriSalus developed its Pressure-Enabled Drug Delivery technology specifically to overcome this challenge.
The PEDD approach uses controlled pressure and flow dynamics to help therapeutic agents move into tumor tissue more effectively. By modifying how therapies are delivered, the technology is designed to improve drug distribution within tumors while limiting delivery to surrounding healthy tissue. The company believes that overcoming these mechanical barriers may help enhance the effectiveness of existing therapies and create new opportunities for future cancer treatments.
The Technology Behind Smart Drug Delivery Systems
At the center of TriSalus’ platform is its SmartValve technology, which is incorporated into the company’s FDA-cleared delivery systems. These devices are designed for use by interventional radiologists, allowing therapies to be delivered directly to targeted areas through minimally invasive procedures.
Unlike conventional infusion approaches, PEDD technology focuses on controlling pressure and flow during treatment delivery. This method aims to improve therapeutic penetration into tumors while maintaining precision during the procedure. The technology has become the foundation of TriSalus’ strategy for treating liver and pancreatic cancers, where effective drug delivery remains a significant challenge.
The TriNav Infusion System
One of the company’s most important commercial products is the TriNav Infusion System. The FDA-cleared device incorporates SmartValve technology and utilizes the PEDD method to support the delivery of therapeutic agents to selected areas of the peripheral vascular system, including liver tumors.
The liver is a common site for both primary cancers and metastatic disease. Because tumors in the liver can be difficult to treat effectively, physicians often seek delivery methods that improve the concentration of therapy reaching cancerous tissue. TriNav was developed to help address this need. The system is currently used in interventional radiology procedures involving liver-directed therapies and represents the company’s leading commercial-stage technology.
Research published in the Journal of Vascular and Interventional Radiology has demonstrated improved therapeutic delivery using the PEDD approach compared with traditional delivery methods. These findings have contributed to growing interest in pressure-enabled drug delivery among physicians and researchers focused on liver cancer treatment. The published research also received recognition within the interventional radiology community, highlighting the potential importance of delivery innovation in cancer care.
Expanding Treatment Options for Pancreatic Cancer
TriSalus Life Sciences has also focused on developing solutions for pancreatic cancer, one of the most aggressive and difficult-to-treat forms of cancer. To address the unique challenges associated with pancreatic tumors, the company developed the Pancreatic Retrograde Venous Infusion (PRVI) System.
The PRVI System is an FDA-cleared device that uses SmartValve technology to support the targeted delivery of therapeutic agents to the pancreas. Unlike liver-directed therapies that often use arterial access, pancreatic treatment can be complicated by the organ’s vascular structure. The PRVI approach utilizes venous access to create a potentially more controlled and targeted delivery pathway.
The company believes this strategy may help improve therapeutic delivery to pancreatic tumors while supporting future immunotherapy applications. As research continues, the PRVI platform may play an important role in expanding treatment options for patients facing limited therapeutic choices.
Combining Drug Delivery With Immunotherapy
Beyond medical devices, TriSalus Life Sciences is advancing an investigational immunotherapy program designed to work alongside its delivery technologies. The company’s lead investigational therapy, SD-101, also known as nelitolimod, is being studied as a potential treatment for multiple solid tumor types. Many tumors create an immunosuppressive environment that prevents the body’s immune system from mounting an effective response. SD-101 is designed to stimulate immune activity and help overcome some of these challenges.
TriSalus Life Sciences believes that combining improved therapeutic delivery with immune activation may offer advantages compared with addressing either challenge independently. This strategy reflects the company’s broader vision of integrating device innovation and immunotherapy into a unified treatment platform. By improving delivery to tumors while supporting immune response, the company hopes to enhance outcomes for patients with difficult-to-treat cancers.
Advancing Through Clinical Research
Clinical development remains a major focus for TriSalus.
The company is evaluating SD-101 and PEDD technology across multiple clinical studies involving liver and pancreatic cancers. These studies include patients with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, metastatic uveal melanoma involving the liver, and pancreatic ductal adenocarcinoma.
Early clinical observations have demonstrated encouraging signs related to safety, biological activity, and immune response. However, additional studies and larger patient populations will be necessary to further evaluate long-term clinical outcomes. The ongoing research program reflects the company’s commitment to developing evidence-based solutions for some of oncology’s most challenging diseases.
Reaching a Major Corporate Milestone
A significant chapter in the company’s history occurred in 2023 when TriSalus Life Sciences completed its merger with MedTech Acquisition Corporation. The transaction enabled TriSalus to become a publicly traded company and begin trading on the Nasdaq Global Market under the ticker symbol TLSI.
For the company, the merger represented more than a financial milestone. It provided increased visibility, expanded access to capital markets, and additional resources to support future growth. The transition to a public company also strengthened TriSalus’ position within the oncology and medical technology sectors as it continued advancing its clinical and commercial programs.
Building a Platform for Future Growth
Since its founding, TriSalus Life Sciences has focused on creating a comprehensive platform rather than a single product. In addition to the TriNav Infusion System and PRVI System, the company has continued expanding its portfolio of delivery technologies designed to address a variety of clinical needs.
This includes additional device innovations intended to support different vessel sizes and treatment scenarios. The company’s long-term strategy is to build a suite of technologies capable of improving therapeutic delivery across multiple solid tumor types. By focusing on delivery science, TriSalus seeks to address a challenge that affects many areas of cancer treatment rather than a single disease category.
Mary Szela’s Leadership and Contribution
A key force behind the company’s growth is Mary Szela, who serves as Chief Executive Officer, President, and Director of TriSalus Life Sciences. Szela joined the company in 2018 and brought extensive experience from the pharmaceutical and biotechnology industries.
Mary Szela earned a Bachelor of Science degree in Nursing and later completed a Master of Business Administration from the University of Illinois Chicago. Her educational background combines clinical healthcare knowledge with business leadership expertise, giving her a unique perspective on healthcare innovation.
Before joining TriSalus, Mary Szela held senior leadership positions at several healthcare organizations. She served as Chief Executive Officer of Novelion Therapeutics and previously led Melinta Therapeutics. Earlier in her career, she spent many years at Abbott Laboratories, where she held leadership roles within the pharmaceutical division and contributed to the commercialization of major healthcare products.
At TriSalus, her leadership has been instrumental in guiding the company’s evolution from a private organization to a publicly traded biotechnology and medical technology company. She has overseen the advancement of the PEDD platform, supported the development of the company’s immunotherapy programs, and helped establish TriSalus as a recognized innovator in targeted drug delivery. Her combination of commercial, operational, and clinical experience has helped position the company for continued growth in the oncology sector.
Looking Toward the Future
The need for better treatment options in liver and pancreatic cancer remains significant. While advances in oncology have improved outcomes for many patients, these cancers continue to present substantial treatment challenges. Effective delivery of therapeutics remains one of the most important barriers to overcoming these diseases.
TriSalus Life Sciences believes its Smart Drug Delivery Systems can help address this challenge by improving how therapies reach tumors. Through its PEDD technology, FDA-cleared delivery systems, and ongoing immunotherapy research, the company is pursuing a comprehensive approach to cancer treatment innovation. As clinical studies continue and new technologies enter the market, TriSalus remains focused on advancing solutions that improve therapeutic delivery and support better patient outcomes.
TriSalus Life Sciences has built its reputation around a simple but powerful idea: cancer treatments can only be effective if they reach their target. Through its proprietary Pressure-Enabled Drug Delivery technology, the TriNav Infusion System, the PRVI System, and its ongoing immunotherapy research, the company is working to overcome some of the most difficult barriers in cancer care.
Under the leadership of CEO Mary Szela, TriSalus has achieved important milestones, including FDA-cleared device commercialization and its successful transition to a publicly traded company. As research progresses, the company’s integrated approach to drug delivery and immunotherapy may help shape the future of treatment for liver, pancreatic, and other solid tumors. For patients and physicians seeking better ways to fight difficult cancers, TriSalus represents a company focused not only on developing treatments but also on ensuring those treatments reach the place where they are needed most.
