Company Summary: TriSalus Life Sciences, Inc.

##Overview TriSalus Life Sciences is a growing oncology-focused medical technology company dedicated to improving treatment outcomes for patients with solid tumors. The company aims to transform the treatment paradigm by integrating an innovative delivery technology platform with standard-of-care therapies and investigational immunotherapeutic agents, specifically nelitolimod, a Toll-like receptor 9 ("TLR9") agonist.

##Core Technologies and Products

• Pressure-Enabled Drug Delivery (PEDD): A platform technology designed to enhance the delivery of therapeutics into tumors by modulating pressure and flow within blood vessels.
• TriNav Infusion System: An FDA-cleared, 510(k) approved device used for localized drug delivery in interventional radiology procedures, primarily in liver cancer treatments.
• PRVI Device: A separate pressure-enabled device for infusions into pancreatic tumors, currently in clinical trials with commercialization not expected before 2026.
• Nelitolimod: An investigational, Class C TLR9 agonist acquired from Dynavax Technologies in July 2020, in early-stage clinical trials for various indications including uveal melanoma, intrahepatic cholangiocarcinoma ("ICC"), hepatocellular carcinoma ("HCC"), and pancreatic cancer.

##Business Focus

• Market Penetration:
  • TriNav's revenue was $29.4 million in 2024, representing 59% growth over the previous year.
  • The device is used primarily for liver cancer treatments such as Transarterial Radioembolization ("TARE") and Transarterial Chemoembolization ("TACE"), with over 21,000 procedures performed to date.
• Clinical Development:
  • One product candidate, nelitolimod, in early clinical phases (Phase 1 and 1b).
  • Enrolled clinical trials for pancreatic cancer (Phase 1/1b, data anticipated end of 2025).
  • Trials for uveal melanoma liver metastases, ICC, and HCC.
• Market Opportunity:
  • Estimated at over $1.6 billion annually in the U.S., with existing and expanding markets in liver cancers, liver metastases, and procedures like Uterine Fibroid Embolization ("UFE") and prostate embolization.
  • Potential applications include treatment for benign goiter, UFE, osteoarthritis, and prostate hyperplasia.

##Employees and Customers

• Employees: Approximately 110 full-time employees as of December 31, 2024.
• Customers:
  • The business primarily generates revenue from hospitals and interventional radiologists performing procedures like TARE and TACE.
  • The company has sales and marketing teams with 53 professionals focused on promoting TriNav to hospitals and academic medical centers nationwide.
  • Reimbursement codes (HCPCS) established for procedures using TriNav help facilitate billing and payments.

##Revenue & Income

• 2024 Revenue: $29.4 million from TriNav device sales.
• 2024 Net Loss: $30.0 million.
• 2023 Net Loss: $59.4 million.
• Accumulated Deficit (as of December 31, 2024): approximately $279.5 million.

##Regulatory Status

• TriNav is FDA-cleared with permanent HCPCS codes assigned for procedures using the device.
• PRVI device is FDA-cleared but not yet marketed, with commercialization expected in 2026.
• Nelitolimod is in clinical development, with multiple ongoing trials.

##Strategic Collaborations

• Long-term partnership with MD Anderson Cancer Center for clinical studies.
• Licensing and asset purchase agreements with Dynavax Technologies for nelitolimod.

##Summary TriSalus Life Sciences develops innovative pressure-modulating devices for targeted drug delivery in oncology, primarily for liver and pancreatic cancers. The company is in early clinical development for nelitolimod, with a focus on transforming immune responses in resistant tumors. It employs a direct sales and marketing model, has generated significant revenue through its TriNav device, and is actively expanding its product pipeline and market presence.