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TriSalus Life Sciences, Inc. (symbol: TLSI) is engaged in the research, development, and sale of groundbreaking drug delivery technology and immuno-oncology therapeutics. The company's mission is to improve outcomes for patients with difficult-to-treat liver and pancreatic cancers.
Core Business: TriSalus focuses on two main product lines: the Pressure Enabled Drug Delivery (PEDD) infusion systems and an investigational agent called SD-101 (nelitolimod). The PEDD infusion systems are already in use and are designed to enhance the delivery of therapeutic agents to tumors. The investigational agent SD-101 aims to stimulate the immune system to better combat hepatocellular cancer, pancreatic cancer, and other solid tumors located in the liver.
Recent Achievements: One of the company's major advancements is the development of TriNav, a new therapy delivery device that incorporates SmartValve technology to optimize the PEDD approach. This innovative device has the potential to significantly improve treatment efficacy and patient outcomes.
Current Projects: TriSalus is actively involved in clinical trials to evaluate the effectiveness of SD-101 in various types of liver and pancreatic cancers. These trials are crucial for securing future regulatory approvals and bringing new treatments to market.
Financial Condition: While detailed financial information is not provided, the company's ongoing research and development initiatives, coupled with its active market presence, indicate a robust commitment to transforming cancer treatment.
Partnerships: TriSalus collaborates with leading academic and medical institutions to advance its research and bring innovative therapies to patients. These partnerships are essential for the clinical validation and widespread adoption of its technologies.
Products:
- PEDD Infusion Systems: These systems enhance drug delivery to tumors, increasing the efficacy of cancer treatments.
- SD-101 (nelitolimod): An investigational agent designed to boost the immune system's response to liver and pancreatic cancers.
- TriNav: The latest innovation in therapy delivery devices, featuring SmartValve technology to improve drug delivery efficiency.
TriSalus Life Sciences (Nasdaq: TLSI) has appointed two healthcare industry veterans to its Board of Directors, effective January 29, 2025. William J. Valle, former CEO of Fresenius Medical Care North America, brings expertise in medical device commercialization and reimbursement. Dr. Gary B. Gordon, former Vice President of Oncology at AbbVie, contributes extensive experience in oncology drug development.
Valle previously managed over 2,400 outpatient facilities and led the integration of critical business functions at Fresenius. Gordon played a key role in developing AbbVie's oncology franchise, including overseeing venetoclax approval and leading major acquisitions. Both appointments aim to advance TriSalus' Pressure-Enabled Drug Delivery™ (PEDD™) technology and Pancreatic Retrograde Venous Infusion (PRVI™) System for improved therapeutic delivery to solid tumors.
TriSalus Life Sciences (Nasdaq: TLSI) has announced a $10 million drawdown from its existing $50 million credit agreement with OrbiMed, a healthcare investment firm. This drawdown was triggered by achieving a product revenue-based milestone of $30 million for the trailing 12-months ending January 31, 2025. With this latest tranche, TriSalus has now accessed a total of $35 million from the credit facility provided by OrbiMed.
TriSalus Life Sciences (NASDAQ: TLSI) reported strong preliminary Q4 2024 results, with revenue reaching $8.3 million, up 44% year-over-year. Full-year 2024 revenue grew 59% to $29.4 million, driven by the TriNav® Infusion System.
Operating Cash Flow improved to ($5.6) million in Q4 2024 from ($10.8) million in Q3. The company ended 2024 with $8.5 million in cash and expects to secure an additional $10 million from OrbiMed in Q1 2025. Management projects over 50% revenue growth in 2025, anticipating positive full-year EBITDA and positive cash flow in H2 2025.
TriSalus Life Sciences (NASDAQ: TLSI) has published research demonstrating the superior performance of their TriNav Infusion System using Pressure-Enabled Drug Delivery (PEDD) technology in delivering Embospheres to liver tumors. The study, published in the Journal of Vascular and Interventional Radiology, showed significant improvements compared to traditional microcatheters:
- 227% increase in Embospheres concentration within tumor tissue
- Improved tumor-to-normal ratio from 2.7 to 4.2
- 209% increase in peritumoral delivery
The research was conducted using a transgenic porcine liver tumor model, utilizing fluorescent imaging and deep-learning algorithms for precise quantification. These results support PEDD's potential to enhance therapeutic delivery while protecting healthy tissue in liver cancer treatments.
TriSalus Life Sciences (NASDAQ: TLSI) announced key changes to its executive leadership team, effective January 6, 2025. James Young, previously Senior Vice President of Investor Relations and Treasurer, has been appointed as Chief Financial Officer, succeeding Sean Murphy who will continue as Chief Manufacturing, Strategy and Business Development Officer and Board member.
The company also promoted Dr. Richard B. Marshak to Chief Commercial Officer and Jodi Devlin to Chief of Clinical Strategy and Operations. Young brings 33 years of experience from Abbott Laboratories, Marshak has extensive leadership experience including CEO roles, and Devlin brings over 30 years of experience in biotech, medical devices, and pharmaceuticals.
CEO Mary Szela emphasized that these changes reflect the company's momentum and position TriSalus to achieve its 2025 goals, highlighting the 18-month transition planning between Young and Murphy to ensure operational continuity.
TriSalus Life Sciences reported strong Q3 2024 results with revenues of $7.3 million, up 42% year-over-year, and nine-month revenues of $21.2 million, up 66%. The company launched the TriNav LV Infusion System and TriGuide Guiding Catheter for larger vessels, expanding into the $375 million embolization market. For 2025, TriSalus projects over 50% sales growth, 20%+ reduction in operating expenses, and expects positive EBITDA and cash flow in H2 2025. The company presented positive Phase 1 data from the PERIO-01 trial in uveal melanoma patients and is seeking strategic partnerships for further development.
TriSalus Life Sciences (Nasdaq: TLSI) has launched the TriNav® LV Infusion System and TriGuide™ Guiding Catheter, expanding its portfolio of Pressure-Enabled Drug Delivery (PEDD™) devices for liver and pancreatic tumor treatment. The TriNav LV Infusion System, designed for vessels 3.5-5.0 mm in diameter, broadens patient eligibility for PEDD technology. The TriGuide Guiding Catheters feature a larger inner diameter and reverse curve design, facilitating femoral access and improving procedural efficiency. Early users reported a 97% satisfaction rate. The devices are eligible for existing HCPCS codes, ensuring seamless reimbursement. CEO Mary Szela emphasized the company's commitment to advancing their pipeline and improving patient outcomes.
TriSalus Life Sciences (Nasdaq: TLSI) has scheduled its third quarter 2024 financial results conference call for Thursday, November 14, 2024, at 9:00 a.m. ET. The company, which focuses on improving outcomes for liver and pancreatic cancer patients through advanced delivery technology and immunotherapy, will discuss Q3 2024 results and provide a business update. The financial results press release will be issued before the call. The event will be accessible via webcast on the company's investor relations website, with a replay available afterward. Interested parties can register online to receive dial-in details.
TriSalus Life Sciences (Nasdaq: TLSI), an oncology company focused on improving outcomes for liver and pancreatic cancer patients, has announced its participation in the 2024 Maxim Healthcare Virtual Summit. Mary Szela, CEO and President of TriSalus, will engage in a fireside chat on Thursday, October 17, 2024, at 12:30 p.m. EDT / 11:30 a.m. CDT.
TriSalus specializes in advanced delivery technology and a novel immunotherapy called nelitolimod. The company aims to enhance treatment outcomes for patients with liver and pancreatic cancer. Interested parties can register for the event through the provided link and find more information about TriSalus and its innovative technologies on the company's website.
TriSalus Life Sciences (Nasdaq: TLSI) has announced the appointment of Dr. Riad Salem to its Scientific Advisory Board. Dr. Salem, the Chief of Interventional Radiology and a Professor at a Chicago institution, brings expertise in radiological research and innovative liver cancer treatments. His addition is expected to support TriSalus's mission in advancing its Pressure Enabled Drug Delivery™ (PEDD™) technology and nelitolimod, a TLR9 agonist.
CEO Mary Szela highlighted Dr. Salem's role in the LEGACY study, which demonstrated significant improvements in response rates and survival using y90 treatment. Dr. Salem will play a important role in the company's DELIVER program, aimed at providing data support for PEDD and nelitolimod in challenging patient populations with liver and pancreatic cancer.
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