MEDTECH ACQUISIT(MTAC) - 2024 Q4 - Annual Report

Financial Performance - TriNav achieved $29.4 million in revenue in 2024, representing a growth of 59.0$30.0 million and $59.4 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of$279.5 million as of December 31, 2024[183]. - As of December 31, 2024, the company had $8.5 million in cash and cash equivalents, which is expected to be insufficient to fund operations for at least the next 12 months[184]. - The company anticipates needing substantial additional funding to finance operations and product development, with potential capital needs influenced by various factors including revenue growth and regulatory approval processes[185]. - Sales of the TriNav device account for primarily all of the company's revenue since its launch in 2020, and future growth depends on physician adoption for various conditions[205]. Market Opportunities - The market opportunity for TACE and TARE procedures is estimated at approximately 62,000 units, representing a potential market value of about$494.0 million[39]. - The TriNav LV is estimated to be applicable for 20,000 uterine fibroid embolizations annually, representing a market opportunity of approximately $160.0 million[41]. - The PROTECT registry study aims to enroll 100 patients, potentially expanding the addressable market for TriNav by 50,000 procedures, equating to an incremental$400.0 million opportunity[43]. - The pancreas infusion technology could treat 2,000 patients annually, adding another market expansion of $400.0 million[44]. - The total addressable market for TriSalus PEDD technology in the U.S. is projected to exceed$1.6 billion annually, with a current market valued at $900.0 million and an additional opportunity of$700.0 million[46]. Product Development and Clinical Trials - The PRVI device for pancreatic tumor treatment is currently in a Phase 1 clinical trial, with commercialization not anticipated before 2026[24]. - The Phase I PERIO-03 clinical trial in pancreatic cancer is enrolled, with data expected by the end of 2025[27]. - The combination of PEDD with nelitolimod aims to improve therapeutic response and patient outcomes across various cancer indications[26]. - Pre-clinical studies indicated that the PRVI method improved drug delivery by 3.6-7.0-fold compared to standard methods, significantly increasing intra-tumoral drug concentrations[68]. - Three Phase 1/1b PERIO studies initiated for nelitolimod targeting pancreatic cancer, ICC, and HCC[74]. Regulatory and Reimbursement - TriNav received a unique HCPCS code (C9797) with a payment rate of 17,957 for calendar year 2025, enhancing reimbursement clarity and integration into billing structures[50]. - A new Technology HCPCS code (C9797) for TriNav procedures became effective on January 1, 2024, with a second unique code (C8004) assigned effective April 1, 2025[170][171]. - The Centers for Medicare & Medicaid Services (CMS) granted a new HCPCS code for TriNav effective January 1, 2024, which may enhance reimbursement clarity[215]. Intellectual Property - The company owns at least 79 registered patents expiring between 2030 and 2040, with an additional 86 pending patent applications, indicating a strong intellectual property position[104]. - For the TriNav device, the company holds five granted U.S. patents and eight foreign patents, with expiration dates ranging from 2031 to 2038[105]. - The company is awaiting three pending U.S. patent applications and 16 foreign patent applications related to nelitolimod, which is a CPG-C type oligonucleotide[107]. Strategic Partnerships and Collaborations - Collaboration with MD Anderson Cancer Center includes a 10 million funding agreement for preclinical and clinical studies[92]. - The company is exploring partnerships to advance the treatment of uveal melanoma due to the changing landscape of second-line therapies[91]. Challenges and Risks - The company faces risks related to its ability to raise additional capital, which could impact its business operations and growth strategy[187]. - The company may need to seek collaborators for its product candidates earlier than desired, potentially on less favorable terms[189]. - The company faces risks related to potential disruptions in the supply of materials necessary for TriNav production, which could increase costs and affect margins[219]. - Any reduction in reimbursement rates for TriNav could negatively impact sales and overall financial condition[216]. Employee and Organizational Development - As of December 31, 2024, the company had approximately 110 full-time employees, including six with Ph.D. or M.D. degrees[178]. - The company actively engages with managers to collect feedback and improve the working environment[179]. - The company’s equity and cash incentive plans aim to attract, retain, and reward personnel to increase stockholder value[179].