Financial Data and Key Metrics - Q4 2023 R&D revenue was 5.3M,downfrom6.1M in Q4 2022, reflecting reduced activity as the BARDA Burn 2 contract neared completion [27] - Full-year 2023 R&D revenue was 18.1M,a28.825.4M in 2022, due to the wind-down of the BARDA Burn 2 contract [30] - Gross margin in Q4 2023 rose to 46.1% from 41.1% in Q4 2022, driven by higher reimbursement rates under the new BARDA PBS contract [29] - Full-year 2023 gross margin increased to 43.6% from 42.7% in 2022, despite a decrease in gross profit, due to the higher reimbursement rate under the BARDA PBS contract [31] - As of December 31, 2023, cash and cash equivalents totaled 4.8M,withnolong−termdebt[34]BusinessLineDataandKeyMetrics−TheDeepViewSystemforburnwoundshasaclinicallyvalidatedaccuracyof92150M multiyear nondilutive contract from the U.S. government under Project BioShield, with an initial award of 54.9M to fund R&D through Q1 2026 [18] - Enrollment for the pivotal study to validate the DeepView System for burn wounds commenced in January 2024, with a target of 240 subjects, including both adult and pediatric patients [19] - The company received UKCA authorization to commence sales of the DeepView System for burn in the UK in February 2024, with the first device deployed in March 2024 [20] - A new 500K contract was awarded in March 2024 to support the development of the handheld version of the DeepView System, bringing total nondilutive support for this project to over 6M[21]MarketDataandKeyMetrics−Thereareapproximately125burncentersintheU.S.,makingthemalimitedandscatteredresource[7]−Thecompanyexpectstogeneratecommercialrevenuesacrossfourplatforms(burnintheU.S.andUK,anddiabeticfootulcerintheU.S.andUK)by2026[22]−Thecompanyhas20allowedU.S.andinternationalpatentsand34pendingpatents,withkeypatentprotectionexceeding14years[23]CompanyStrategyandIndustryCompetition−ThecompanyaimstointegratetheDeepViewSystemintotheclinicaltreatmentflowatemergencydepartments,hospitals,burncenters,andclinicsforbothdiabeticfootulcersandburnwounds[17]−TheDeepViewSystemisdesignedtoprovideimmediateandaccuratewoundcareassessment,reducingpainandsufferingforpatientsandimprovingresourceallocationforinstitutions[5][6][7]−Thecompanyformedawholly−ownedsubsidiary,SpectralIP,tofocusondevelopingoracquiringIPapplicabletothebroaderAIecosystemwithinhealthcare,witha1M investment from an affiliate of its largest shareholder [24] Management Commentary on Operating Environment and Future Outlook - The company expects 2024 revenue guidance of approximately 28M,a5555M BARDA funding and billing process - The company bills the U.S. government monthly for R&D expenses, with payments typically received within a few weeks [60] - The funding covers clinical trial costs, including overhead [61][62] Question: Regulatory hurdles for broader expansion in the UK - The UKCA mark allows for UK-wide deployment, with no significant additional regulatory hurdles [65] Question: Revenue structure for the DeepView System - Revenue includes device sales, annual license fees for the AI, and service/maintenance components [66] - The AI model is updated annually, with a robust dataset of 340 billion data points [69][70] Question: Potential for Middle East market expansion and 2024 margin expectations - The company is actively pursuing opportunities in the Middle East, leveraging the UKCA mark for regulatory access [78] - Margins for 2024 are expected to be consistent with Q4 2023, potentially slightly higher due to the BARDA PBS contract [79][80]