Minimally Invasive Glaucoma Surgical Instrument

DESCRIPTION (provided by applicant): Glaucoma remains a major public health problem in America and worldwide. It is estimated that about 3 million Americans and over 67 million people in foreign countries suffer from this debilitating disease. Blindness from glaucoma and treatment of glaucoma impose significant annual costs to the United States Government in Medicare, Medicaid, Social Security, and other healthcare expenditures. Current approaches to glaucoma management include pharmaceuticals, surgical methodologies, and surgical drainage implants. Although each of these treatment approaches provides some positive results among certain subsets of patients, there exists a need for a treatment approach that is more universally efficacious and cost-effective. NeoMedix Corporation is developing an innovative, proprietary Atraumatic Goniectomy System (AGS) technology as a surgical treatment for glaucoma. AGS is the first technology to offer the potential for a cost-effective, user-friendly, ab interno surgical procedure to effectively and permanently reduce IOP in glaucoma patients by atraumatically removing a 90x sector of trabecular meshwork overlaying Schlemm's canal in order to re-establish outflow of aqueous humor through the collective channels. Preliminary studies with an early AGS prototype system have demonstrated that sectors of the trabecular meshwork can be rapidly and readily removed without trauma to the underlying tissues of Schlemm's canal. The specific aims of this proposed research for advancing AGS toward commercialization are as follows: 1) design and build an advanced instrument prototype, 2) perform experimental studies to select and optimize design and operating parameters, and 3) evaluate the basic safety and effectiveness of the AGS technology in the freshly harvested human cornea model.