Financial Performance - TriNav achieved $45.2 million in revenue in 2025, representing growth of 53.4% compared to the previous year[24]. - The company incurred net losses of $39.2 million and $30.0 million for the years ended December 31, 2025 and 2024, respectively, with an accumulated deficit of $330.6 million as of December 31, 2025[168]. - The company anticipates incurring increased sales and general administrative expenses for the foreseeable future, which may lead to continued losses[168]. - The company is highly dependent on the sales of its TriNav device, and any decline in market acceptance could adversely affect its business[166]. - The company may require substantial additional capital to finance operations and product development, and there is uncertainty regarding the availability of such financing[169]. - The company has borrowed $35.0 million under the OrbiMed Credit Agreement, which is secured by substantially all of its assets[176]. - The company is required to maintain at least $5.0 million of unrestricted cash and cash equivalents at all times under the OrbiMed Credit Agreement[177]. Product Development and Clinical Trials - The PRVI device for pancreatic tumors is currently in a Phase I trial and is expected to be commercialized by 2026[28]. - TriSalus is supporting two Investigator Initiated Trials of nelitolimod, with results expected in 2026[31]. - The combination of PEDD with nelitolimod aims to improve patient outcomes by addressing immunosuppressive properties in solid tumors[30]. - TriSalus is collaborating with leading academic sites to expand clinical evidence for PEDD in TACE and TARE procedures[42]. - Three Phase 1/1b Pressure Enabled Regional Immuno-oncology (PERIO) studies have been initiated, with results expected in 2026[80]. - The company has completed Phase 1 and Phase 1b clinical trials for nelitolimod, focusing on various cancers[198]. - The company has multiple investigator-initiated trials at major medical centers exploring the benefit of TriNav and the PEDD method in TARE, TACE, and uterine fibroid embolization[76]. Market Opportunity - The estimated market opportunity for TriNav's current portfolio is approximately 62,000 units, translating to about $494 million based on a unit price of $7,983[46]. - The total addressable market for TriSalus PEDD technology in the U.S. is projected to exceed $2.3 billion annually, with a current market valued at $1 billion and an additional opportunity of $1.3 billion[54]. - The market opportunity for nelitolimod includes approximately 137,000 new cases of liver cancers and over 60,000 cases of pancreatic cancer diagnosed annually in the U.S.[86]. - The company estimates potential applications for TriNav in treating uterine artery embolization, thyroid artery embolization, and prostate artery embolization, representing significant market opportunities[49]. Regulatory Environment - The company is subject to extensive regulation by the FDA, impacting the cost and time needed for product approvals[106]. - TriSalus's clinical trials must comply with FDA's Good Clinical Practice (GCP) requirements and are subject to the Bioresearch Monitoring (BIMO) program[122]. - The FDA's review process for an NDA typically takes ten months for non-priority reviews and six months for priority reviews, with a 60-day acceptance period[131]. - The Orphan Drug Act provides seven years of exclusivity for drugs treating rare diseases, with benefits including tax credits and exemption from user fees[145]. - The FDA has expedited programs like Fast Track and Priority Review to facilitate the development and review of drugs for serious conditions[146]. - The company is subject to numerous complex regulatory requirements, and failure to comply may harm its business[166]. Competitive Landscape - Intense competition in the biopharmaceutical and medical device industries poses risks to market share and business operations[218]. - Changes in third-party coverage and reimbursement could materially impact the ability to sell products profitably[213]. - The healthcare industry trend towards cost containment may affect reimbursement levels for products[217]. Strategic Partnerships and Collaborations - The company has entered into a five-year collaboration agreement with MD Anderson Cancer Center, committing $10 million for preclinical and clinical studies[89]. - TriSalus is exploring potential partnerships to advance nelitolimod development to Phase II trials following data analysis from early studies[31]. - The company is seeking potential partners for funding to advance nelitolimod development in Phase II trials, with results expected in 2026[198]. Technology and Innovation - The PEDD technology has been used in over 31,000 procedures, primarily for TACE and TARE[24]. - In clinical studies, PEDD devices demonstrated a 33% to 90% increase in tumor deposition and a 24% to 89% decrease in non-target embolization compared to standard catheters[39]. - The SmartValve technology in PEDD devices preserves over 70% of forward blood flow, enhancing therapeutic delivery[34]. - TriNav has launched new devices, including TriNav FLX and TriNav XP, aimed at enhancing therapeutic delivery and expanding applications, eligible for existing reimbursement codes[47]. Employee Relations and Company Culture - The company considers its relationship with employees to be good, healthy, and transparent, actively engaging with managers for feedback[162]. - The company has approximately 102 full-time employees as of December 31, 2025, with no labor union representation[161].
MEDTECH ACQUISIT(MTAC) - 2025 Q4 - Annual Report