Enhanced endothelialization of nanomatrix coated flow diverter for intracranial aneurysms

Approximatelyof the population has unruptured cerebral aneurysmsapproximatelymillion people in the USAboutrupture per yearwith devastating consequencesAboutof patients with ruptured aneurysms dieandofwho survive have significant disabilitiesCoil embolization therapy is associated with a high rate of recurrenceFlow diverters are increasingly being used to cover the neck of the aneurysm providing more durable occlusionHoweveruntil endothelialization and aneurysm occlusion has occurred patients are at increased risk of thromboembolic complications and increased intracranial hemorrhage due to necessary dual antiplatelet therapyWe have developed a nanomatrix coating that mimics the characteristic properties of native endotheliumThuswe hypothesize that the nanomatrix coating on the flow diverter can enhance endothelial coverage and accelerate aneurysm closureThe coating provides sustained release of nitric oxideNOovermonthsthus recruiting and retaining endothelial cellsIt also incorporates an endothelial cell adhesive ligand that promotes endothelial cell retention and migrationThe bionanomatrix is a biocompatable peptide based material and is coated on the coils by simple water evaporationThis coating method minimizes the risk of inflammatory responsesIn this Phase I SBIRwe propose to evaluate the coating for flow diverters for treatment of brain aneurysmsThis will includecharacterization of nanomatrix coatingassessment of coating structural integrityevaluation of endothelial cell attachmentgrowth and migrationevaluation of platelet adhesionandevaluation of monocyte adhesion to endothelial cells and expression of monocyte inflammatory genesIn collaboration with DrKadirvelandapos s group at the Mayo Clinicin vivo assessment will verify that the nanomatrix coating improves endothelial coverage of flow diverters compared to a standard flow diverter in a rabbit aneurysm modelDevelopment of the nanomatrix coating that enhances occlusion of aneurysms and healing over the flow diverters may have significant impact in the treatment of patients with brain aneurysmsWith successful completion of Phase Iwe plan to move forward in Phase II towards IDE submission Brain aneurysms carry the devastating risk of ruptureleading to death or permanent disabilityCurrently available flow diverters used to treat aneurysms are limited by a significant risk of thromboembolic complications until endothelialization and aneurysm closure has occurredMedications to prevent clotting place patients at increased risk of bleeding during these several months awaiting endothelial coverageEndomimeticsLLC has developed a novel nanomatrixwhichwhen coated onto coilscould enhance endothelialization and reduce the risk of embolic stroke or brain hemmorhage