ISENSE, LLC — Department of Health and Human Services SBIR Phase II: NIAID

Description

Sepsis is the leading cause of deaths in US hospitals contributing to or causingof all UShospital deaths and is the most expensive condition treated in US hospitalscosting more than $billion annuallyMore thanmillion blood culture bottles are produced annuallywith a marketsize greater than $B in the US and EU aloneThe two year phase II period spanned Februaryto FebruaryRAIThedevelopmentsfunded in part by this granthave created a new paradigm to diagnose blood streaminfection causing sepsisThe work of this grant has assisted in creating the SpecID blood culturesystemwhich the company is now commercializingThe SpecID solution replaces the presentstepprocess for characterization of blood samplescurrently divided intodetection of infectionan obligatory Gram stain for all positive cultures performed on the bench by trained technicianand thenspecies ID by MALDI TOFagain requiring skilled sample preparationThe SpecIDsolution combines faster detectionmore accurate Gram status determination than the benchtopstainand ID more accurate than MALDIin a single fully automated step which reduces the time toIDstreamlines lab workflowand saves significant costThe result is improved patient outcomesand improved lab operating performanceThe objectives of this Commercialization Readiness PilotCRPProgram proposal reflect the keygoalsnot supported by the Phase II or Phase IIB programs but required to achieve commercialmarket entry of the SpecID blood culture system includingdevelopment of blood culture mediamanufacturing processesdevelopment of quality control and documentation systemsFDA strategy toachievekapproval and development of the SpecID blood culture instrument and blood culturebottle sensor attachment Sepsis is the leading cause of deaths in US hospitals contributing to or causingof all UShospital deaths and is the most expensive condition treated in US hospitals costing for than $billion annuallyRapid identification of the infection is critical for effective treatmentTheultimate goal of this project is to bring hospitals a new technology solution that reduces the timeto identification in a single automated instrumentThe result is improved patient outcomes andimportantly in today s cost critical healthcare system the solution is less expensive than currentpractice