Mynosys Cellular Devices, Inc. — Department of Health and Human Services SBIR Phase II: NEI

Description

PROJECT SUMMARYABSTRACTThis project seeks to obtain regulatory approval and to conduct pre commercialization manufacturing RandD activities for an innovative microtechnology enhanced surgical device that solves a significant therapeutic bottleneck in the treatment of lens cataract in children and adultsAs the leading cause of childhood blindnesslens cataract interferes with the optical performance of the eye and if untreatedcan result in lifelong deficits in visual perception or blindnessCataract surgery in adultswithmillion plus cases per yearis the most common surgical procedure in the United States thatwith the aging demographicswill continue to add to our healthcare burdenThe first step in pediatric and adult cataract surgery is technically the most challenging and involves the creation of a hole in the thin lens capsulecapsulotomyto provide access for the subsequent removal of the diseased lens and if neededthe implantation of an artificial intraocular lensDue to the unique biomechanical properties of the immature lens capsulecurrent adult procedures for creating the capsulotomy openingif applied to infants and young childrenonly have achance of successAs a resultpediatric cataract surgeons must make do using devices with tissue chopping functions originally designed for non cataract surgical usesresulting in suboptimal capsulotomiesIn adultscapsulotomy complications manifest ascases of capsule tears each yearwhich alter the surgical plan and can produce suboptimal vision correctionRecent studies show that perfectly sized and circular capsulotomies produced by femtosecond lasers potentially lead to better clinical outcomesHowever femtolasers are extremely expensive for physicians to acquire and cost patients an extra$out of pocket per eyethus limiting the benefits of this technology to a small fraction of themillion cataract surgery patients each yearThe overall goal of this project is to provide physicians with a low cost device that automatically delivers dimensionally perfect capsuotomies for all pediatric and adult patients undergoing cataract surgeryIn Phase IIIand IIBwe developed an easy to use disposable capsulotomy device that uses a novel microscale tissue cutting technology to provide quickconsistent capsulotomies across a range of surgical skillsThe device is based on a microfabricated nitinol capsulotomy ring element housed within a collapsible elastomeric housing to produce precise capsulotomies on a millisecond time scale using a multipulse electrical energy algorithmThe device is inserted through a small corneal incision and re expands to produce amm diameter capsulotomyUnder the CRP programwe will perform a FDA mandated clincial trial needed for device approvalIn additionwe will conduct late stage RandD in collaboration with manufacturing partners to develop new technology for efficient high volume manufacturingThe successful completion of these activities will position this product for successful market entry and thereby provide low costinnovative vision care to all