ALEO BME INC — Department of Health and Human Services SBIR Phase I: 300

Description

The global cerebral spinal fluidCSFmanagement market is anticipated to reach $B byProblems related to CSF leaks and intracranial infectionssuch as meningitiscan be caused bytraumaneurosurgical proceduresand pre existing defects in various regions of the skullThese problems are a major cause of neurosurgical morbidity and have limited treatment optionsThe median cost of fixing a CSF leak was over $Currently available commercial dural sealants include fibrin glues and biopolymerssuchas BioGlue and DuraSealrespectivelyThese products are limited by their poor performance inaqueous environmentsweak adhesion on wet tissuesshort degradation timedangerouslyhigh swelling ratiosand cytotoxicityClinical outcomes are often unsatisfactory andpost operative CSF leakage risk remains highoften incurring significant additional health carecostsThe primary goal of the Phase I proposal is to develop Aleo BMEandapos s proprietary biphasic glueBP Gluefor the repair of compromised dura in the brainLeveraging the natural plantadhesion mechanisms utilized by English ivy to adhere to diverse substrates and particle packingtheory in developing mechanically strong composite materials in cement industryBP Glue isnature inspiredfastcuring biomaterial capable of forming strong adhesive sealingin an aqueous environmentbacterial impermeabledegradableand may be easilyapplied in a medical settingBP Glue mitigates serious risks associated withpost surgical leaksinfectionsand its predictable degradation process accelerateshealthy tissue repair and integrationallowing surgeons to successfully treat patientsthat would otherwise endure lengthy recoveries fraught with serious complicationsThe noveltyof BP Glue lies in the unique combination of plant inspired bioadhesion strategy and particlepacking theory borrowed from cement industry for biomimetic wet tissue adhesivesdevelopmentThe BP Glue system is composed of two WPU components with opposite chargesFigThe scientific premise of the proposal is as followsBP Gluedemonstrates afold greater wet tissue lap shear strengthfold greater burst strength andfolder greater T pull strength than the commercial gold standardsfibrin glue and DuraSealBPGlue is effective to prevent CSF leakage in a preclinical animal modelandBP Glue adhesionmechanism simulates that of English Ivy in which nanoparticles secreted by English Ivy areionically crosslinked to form an inter locking film capable of binding to rough surfacessuchas buildingstrees or biological tissues in combination with that of particle packingtheory under which compositing particles with optimal size difference maximizes the cohesivestrength of the resultant composite materialsThe expected outcome of this proposal is that wewill develop a new type of fully synthetic bioinspired biodegradable adhesive sealant andvalidate the feasibility for CSF leak prevention and dura repair in a rat CSF leak model andlay a foundation for large animal studies in Phase II Each yearmillion people in the US experience a traumatic brain injurythe primary cause ofdural damage and subsequent CSF leaksThe global CSF management market is anticipated to reachbillion USO byThe primary goal of this SBIR Phase I proposal is to develop Aleo BMEandapos sproprietarybiphasic glueBP Gluefor the dura repair and CSF leak prevention in a rat CSF leakmodel