CLEARSIGHT, LLC — Department of Health and Human Services SBIR Phase II: N

Description

AbstractThe exponential increase of diabetics and the elderly in the U Shas more than tripled the number of cataract surgeries performed in just two decadesAs many as half of these surgeries will lead to posterior capsular opacificationPCOwhich requires follow up Nd YAG laser capsulotomy surgeryWithout this additional procedurepatients can suffer permanent vision loss and disabilityIn many countries laser capsulotomy is not availableand PCO results in blindnessAs the primary complication of cataract surgeryPCO results in andgt $million in annual costs for the U SMedicare system aloneCosts are expected to exceed $billion byThe number of diagnosed diabetics in the U Shas far out paced predictionsThis group experiences high rates of cataract formation with more difficult recovery from surgeryIf current trends continueas many as one out of three Americans could be diabetic by mid centurywhich will place increasing financial stress on our healthcare systemIt is estimated that overof the world s visually impaired are living in developing countries and follow up laser capsulotomy surgery is rarely an option in these areasthereforepatients experience vision loss and or blindness due to lack of resourcesIt is thus important to eradicate PCO globallyIdeallyno follow up surgery would be required after the initial cataract removalAn IOL that eliminates PCO would greatly reduce health risks and costs associated with cataract surgeriesPCO results from migration of lens epithelial cellsLECsbehind the intraocular lensIOLThese cells cause the opacification of the posterior lens capsule that impairs visionSharklet Technologies proposes to continue development of a next generation IOL that will prevent PCOand to team with an industry partner to market the device in the U Sand worldwideThe market is continually seeking improvements in IOL materialsespecially in elimination of glistenings that cause decreased contrast sensitivity and result in loss of vision qualityThis ClearSight IOL will be the first IOL to thus provide truly clear vision via three key featuresan outer ring and membrane that maintain capsular bag expansion and prevent equatorial LECs from migrating along the posterior surface of the capsular bagthe Sharklet pattern that further inhibits migration of LECs into the visual axisanda novel material formulation that is free of glisteningsOur Phase I SBIR studies exceeded milestonesdemonstrating statistically significant reduction in LEC migration in vitroreductionand PCO in rabbitsreduction in visually significant PCOWe are making rapid progress in our Phase II project to manufacture ClearSight IOLs and an accompanying injector and validate the safety and efficacy of these designs in anticipation of submitting a regulatory package for an Investigational Device Exemption for human clinical studies on the ClearSight IOLPhase I and II success and the broad based technicalclinicaland business skills of our expertmulti disciplinary team sets the stage for a successful commercialization project to complete pilot clinical studies and obtain a CE Mark for our deviceallowing us to move into post market studies to support regulatory approval in the U S Project Narrative A serious complicationwhich causes a secondary blindness eventoccurs intoof cataract surgeriesThissecondary cataractrequires follow up laser surgery that increases patient risk and represents over $million in added medical costs per year in the U S aloneSharklet Technologies proposes to commercialize a next generation intraocular lens that has a novel protective membrane design incorporating a micro patterned surface to prevent secondary cataract formation and is made in a novel material to eliminate glisteningschanges in material structure that lead to visual disturbancesSuccessful completion of this SBIR project will enable commercialization of a device that will have a significant impact on improving vision quality and reducing healthcare costswhich are rising steadily in the U Sdue to growing patient populations with increased cataract susceptibility