TRICOL BIOMEDICAL, INC — Department of Health and Human Services SBIR Phase II: 200

Description

AbstractSerious non variceal upper gastrointestinal bleedingNVUGIBis a major cause of morbidity and mortality worldwideIncidence of NVUGIB in the US is close toevents peradultswith approximatelyhospital admissions annuallyUS treatment and prevention of NVUGIB continues to be a major medical emergencycostingmillion dollars every yearFailure in standard of care for NVUGIB results in mortality rates fromin the USAn improved hemostatic approach to NVUGIB will significantly reduce hemorrhage related morbidity and mortality with reduced cost of hospital careThe ideal device would be nontoxicable to be stored foryears without refrigerationbe easily deployedprovide immediate hemostasis for difficult to control brisk andamppulsatile bleedingallow successful low accuracy acuity placement in a bleeding obscured surgical fieldnot require significant follow up or removaland dissolve or be digested in the gastric cavity in underdaysThis proposal addresses finalization in development of such a deviceTo address serious NVUGIBTricol Biomedical andampOregon Health andampScience University propose to finalize development of a foldablehighly efficaciouschitosan gastrointestinal hemostatic dressingCGHDwith wire deliveryWDvia a standard endoscope working channelThe primary objective of this research proposal is to complete development of a novel efficacious CGHD DW and its management of challenging acute GI bleeding in the gastric environment that can be left in place to be fully digested or dissolved in less thanhoursThe final CGHD WD device will be validated in aday study of a large animal model of briskpulsatile UGIB to support an investigational device exemptionIDEfor a Phase I clinical studyThe central hypothesis of this Phase II proposal is that the finalized CGHD DW with delivery through the standard endoscope working channel will provide effectiveimmediate and sustained hemostasis for brisk NVUGIB NarrativeSerious non variceal upper gastrointestinal bleedingNVUGIBis a major cause of morbidity and mortality worldwide with incidence of NVUGIB in the US close toevents peradultswith approximatelyhospital admissions annuallyThe chitosan gastrointestinal hemostatic dressingCGHDdelivered by wireWDvia the working channel of a standard endoscope will provide for rapid deployment of an advancedtissue adherenthemostatic dressing to provide immediate hemostasis for difficult to control NVUGIB and allow for successful low accuracy acuity placement in an obscured surgical field without need for significant follow up or removalThe successfully completed CGHD DW device will significantly reduce NVUGIB hemorrhage related morbidity and mortality with reduced cost of hospital care