Exoflo Extracellular Vesicles Medicine 03 December 2024 Extended indication Exoflo extracellular vesicles monotherapy for treatment of moderate to severe Acute respiratory distress syndrome in hospitalized adults and elderly Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Exoflo Extracellular Vesicles Domain Lung diseases Reason of inclusion New medicine (specialité) Main indication Unknown Extended indication Exoflo extracellular vesicles monotherapy for treatment of moderate to severe Acute respiratory distress syndrome in hospitalized adults and elderly Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Direct Biologics Portfolio holder Mechanism of action Unknown Route of administration Unknown Therapeutical formulation Unknown Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP No Submission date June 2025 Expected Registration July 2026 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks NCT05354141 Therapeutic value Current treatment options Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Duration of treatment Frequency of administration Dosage per administration References Additional remarks Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions Unknown Indication extensions References Additional remarks Other information Additional remarks