ENDOMIMETICS LLC — Department of Health and Human Services SBIR Phase II: 400

Description

More thanU Spatients have end stage renal disease and overutilize hemodialysis as their renal replacement modality of choiceThe Achilles Heel in the care of dialysis patients is the development of a functioning and durable vascular accesspreferably an arteriovenous fistulaAVFThe annual cost of treating vascular access dysfunction totals over one billion US dollarsThis is largely due to the high proportion of AVFs that fail to matureAfter creationsixty percent of AVFs fail to mature successfully for dialysis usedue to early venous neointimal development and inadequate vasodilationAt presentthere are no effective therapies to promote vascular access maturationEndomimetics has developed a nitric oxideNOreleasing nanomatrix gel that mimics the characteristic properties of native endotheliumThis nanomatrix can be applied on the dialysis AVF at the time of creationIn our Phase I SBIRthe nanomatrix gel demonstrated release of NO overdaysinhibited neointimal hyperplasiaand reduced expression of inflammatory markers in a rat AVF modelThe Endomimetics nanomatrix gel is a biocompatible peptide based material and minimizes the risk of inflammatory responsesIn this Phase II SBIRwe propose to evaluate the efficacy of the nanomatrix gel for AVF maturation at a clinically relevant time pointAimwill include evaluation of gelation propertiesex vivo blood vessel dilationand assessment of NO effects on inhibition of inflammationIn collaboration with DrLee at the University of Alabama at BirminghamAimsandwill evaluate the efficacy of the Endomimetics nanomatrix gel in an established rodent AVF modeland in a porcine modelDevelopment of the Endomimetics NO releasing nanomatrix gel that promotes AVF maturation may have significant impact in the treatment of patients requiring dialysisWith successful completion of Phase IIwe plan to move forward in discussion with the FDA