Financial Performance - TriNav achieved 18.5millioninrevenuein2023,withfourthquartergrowthof77368 million based on current pricing[52]. - TriNav received a unique and permanent HCPCS code (C9797) with a payment rate of 16,724.70forcalendaryear2024,enhancingreimbursementoptions[55].ProductDevelopmentandClinicalTrials−ThePRVIdeviceforpancreatictumorsiscurrentlyinclinicaltrials,withcommercializationnotanticipatedbefore2025[29].−ThecompanyisadvancingitsPancreaticRetrogradeVenousInfusionDevice(PRVI),currentlyinPhase1clinicaltrialsforlocallyadvancedpancreaticcancer[77].−ThePhase1PERIOstudiesaretestingthenelitolimod/PEDDtherapeuticplatforminindicationssuchaslocallyadvancedpancreaticcarcinomaanduvealmelanomawithlivermetastases[90].−ThecompanyhasinitiatedthreePhase1/1bstudiesfocusedonenhancingimmunotherapyresponsesinliverandpancreatictumorsusingnelitolimod[90].−ThecompanyanticipatesreportingfullPhase1experienceinthesecondhalfof2024,withPhase1benrollmentbeginningifdataremainssupportive[120].−ThecompanyisstudyingthePRVIdeviceincombinationwithnelitolimodinthePERIO−03trial,whichhasreceived510(k)clearance[186].MarketOpportunityandPatientDemographics−Theincidenceofprimarylivertumorsisover41,000casesannuallyintheU.S.,withanadditional96,000individualsdiagnosedwithlivermetastases[48].−Approximately40286 million[49]. - Approximately 137,000 new cases of liver cancers and over 60,000 cases of pancreatic cancer are diagnosed annually in the U.S., with more than 80,000 potentially addressable through the nelitolimod/PEDD platform[106]. - The five-year survival rate for pancreatic ductal adenocarcinoma (PDAC) is only 13%, highlighting the high unmet medical need in this area[108]. Technology and Innovation - The unique SmartValve on the PEDD device preserves more than 70% of forward blood flow, enhancing therapeutic delivery[37]. - PEDD has demonstrated a median increase of 24% in the tumor-to-normal liver ratio (T/N ratio) and a median increase of 23% in tumor dose delivery compared to standard catheters[45]. - The proprietary PEDD technology addresses the limitations of current cancer immunotherapy approaches by overcoming intra-tumoral pressure barriers, enabling effective therapeutic delivery[102]. - The SmartValve technology in TriNav allows for greater therapeutic delivery to tumors while minimizing exposure to healthy tissue[53]. - TriNav's competitive advantage lies in its ability to modulate pressure and flow, unlike standard microcatheters, which lack clinical evidence for improved therapeutic delivery[70]. Regulatory and Compliance - The company plans to seek FDA approval for nelitolimod through a 505(b)(1) regulatory pathway, which requires data demonstrating its contribution to the efficacy of the therapeutic regimen[185]. - The FDA's goal for a non-priority review of an NDA is ten months, but this can be extended by requests for additional information[190]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a new product outweigh its risks prior to approval[189]. - The company is subject to various healthcare laws and regulations, which may impose significant penalties if non-compliance is determined[221]. - The company is required to report annually to CMS information related to payments and transfers of value to healthcare professionals under the Physician Payments Sunshine Act[223]. Collaborations and Partnerships - The collaboration with MD Anderson Cancer Center includes a 10millionfundingagreementforpreclinicalandclinicalstudies,with6 million already paid[129]. - The company is exploring collaborations with therapeutic partners to enhance the uptake of various therapeutics using the PEDD approach[86]. - Collaboration with Hangzhou for PEDD combination therapies includes a milestone payment of $2.5 million for each therapy receiving regulatory approval[146]. Manufacturing and Operations - Manufacturing of TriNav is conducted in Westminster, Colorado, with adequate capacity for future demands[141]. - The principal office is located in Westminster, Colorado, leasing approximately 21,000 square feet of office, manufacturing, and warehouse space, with the lease expiring on December 31, 2026[223]. - The company has approximately 112 full-time employees, including 10 with Ph.D. or M.D. degrees, as of March 5, 2024[225]. Employee Relations and Corporate Governance - The company has not experienced any material work stoppages and maintains a good relationship with its employees[225]. - The company actively engages with managers to collect feedback on improving the working environment[225]. - The company may need to negotiate new leases or evaluate additional space for operations in the future[224].
