Sharklet Technologies Inc. — Department of Health and Human Services SBIR Phase II: N

Description

DESCRIPTION provided by applicant The exponential increase of diabetics and the elderly in the U S has more than tripled the number of cataract surgeries performed in just two decades As many as half of these surgeries will lead to posterior capsular opacification PCO which requires follow up Nd YAG laser capsulotomy surgery Without this additional procedure patients can suffer permanent vision loss and disability In many countries laser capsulotomy is not available and PCO results in blindness As the primary complication of cataract surgery PCO results in andgt $ million in annual costs for the U S Medicare system alone Costs are expected to exceed $ billion by The number of diagnosed diabetics in the U S has far out paced predictions This group experiences high rates of cataract formation with more difficult recovery from surgery If current trends continue as many as one out of three Americans could be diabetic by mid century which will place increasing financial stress on our healthcare system It is estimated that over of the worldandapos s visually impaired are living in developing countries and follow up laser capsulotomy surgery is rarely an option in these areas therefore patients experience vision loss and or blindness due to lack of resources It is thus important to eradicate PCO globally Ideally no follow up surgery would be required after the initial cataract removal An IOL that eliminates PCO would greatly reduce health risks and costs associated with cataract surgeries The ideal device would not use potentially harmful pharmacologic agents that can result in inflammation or other complications PCO results from migration of lens epithelial cells LECs behind the intraocular lens IOL These cells cause the opacification of the posterior lens capsule that impairs vision Sharklet Technologies proposes to continue development of a next generation IOL that will prevent PCO and to team with an industry partner to market the device in the U S and worldwide This membrane protected IOL the ClearSight IOL will be modified with the Sharklet pattern on the area surrounding the optic The ClearSight IOL provides two key features a dual square edge that maintains capsular bag expansion and prevents equatorial LECs from migrating along the posterior surface of the capsular bag and the Sharklet pattern that further inhibits migration of LECs into the visual axis Our Phase I SBIR studies exceeded milestones demonstrating statistically significant reduction in LEC migration in vitro reduction and PCO in rabbits reduction in visually significant PCO Phase II goals are to manufacture ClearSight IOLs and an accompanying injector validate the safety and efficacy of these designs and submit a regulatory package for an Investigational Device Exemption for human clinical studies on the ClearSight IOL by the end of Phase II Phase I success and the broad based technical and business skills of its expert multi disciplinary team sets the stage for a successful Phase II manufacturing and validation project designed to lead to post Phase II clinical trials in collaboration with a third party investor or industry partner PUBLIC HEALTH RELEVANCE A serious complication of cataract surgery called andquot secondary cataract andquot occurs in to of cataract surgeries and requires follow up laser surgery that represents an additional risk to patients and over $ million in added medical costs per year in the U S alone Sharklet Technologies proposes to develop a next generation intraocular lens that has a novel protective membrane design incorporating a micro patterned surface to ultimately prevent secondary cataract formation Successful results of this SBIR project will enable commercialization of a device envisioned to have a significant impact on improving patient care worldwide and reducing healthcare costs which are rising steadily in the U S due to growing patient populations with increased cataract susceptibility