SBIR-STTR Award

The broader/commercial impact of this SBIR Phase I project will study and improve the process of corneal graft preparation in eye banks for use in vision-restoring transplant procedures to treat corneal diseases, affect more than over 4 million people in the United States. Descemets membrane endothelial keratoplasty (DMEK) is an advanced procedure involving transplantation of a thin layer of the cornea with outstanding clinical outcomes. However, this places a significant burden on eye banks as they use a difficult, time- and cost-intensive process to isolate the thin layer of the donor cornea (DMEK graft), subsequently provided to a surgeon for transplantation. The proposed research will enable development and evaluation of a novel to decrease the difficulty of DMEK graft preparation, reduce the time required, and expand the eligible donor pool. Improving the graft preparation process will result in increased economic efficiency within eye banks, and help enable greater access to vision-restoring DMEK procedures to individuals in the United States. This project seeks to develop and evaluate a novel, first-in-class graft preparation device that standardizes, de-skills, and improves the viability of the liquid bubble technique (LBT) for DMEK graft preparation. The proposed device overcomes the major barriers to LBT adoption: (1) consistent needle insertion into the correct tissue plane and (2) endothelial cell loss (ECL) due to high pressure in the cornea. It does so via a stabilizing corneal base in conjunction with a needle insertion system to allow for simple, standardized DMEK preparation in under 5 minutes with less than 5% failure rates at appropriate graft viability, even in diabetic and obese donor corneas.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project relates to the significant, unmet clinical and commercial need of more than 25 million individuals waiting for a corneal transplant to restore their vision. Corneal blindness leads to an increased risk of physical harm, mental disorders, social isolation, and cognitive decline, resulting in an over 15-year reduction in life expectancy. Fortunately, 95% of corneal diseases can be treated via a transplant. Partial thickness corneal transplants are innovative procedures that provide the best clinical outcomes for over 90% of patients with corneal disorders; however, the difficulty of safely and efficiently separating the layers of the cornea to prepare corneal grafts and perform transplants has led to under-utilization of these procedures. This project seeks to commercialize single-use, assistive devices for tissue separation in corneal graft preparation and corneal transplant surgery with the potential to improve the efficiency of eye banks and ophthalmologists, increase access to corneal transplants, and improve the outcomes of these procedures. These devices have a time- and capital-efficient path to improving patient outcomes and entering the $340 million global market, annually. This Small Business Innovation Research (SBIR) Phase II project involves development of novel, first-in-class graft preparation and assistive surgical devices that standardize, de-skill, and improve the viability of the liquid bubble (LBT) and big bubble techniques (BBT) in corneal transplantation. LBT is a graft preparation technique shown to prepare grafts in minutes from all donor eyes; however, it is more difficult and rarely used by eye banks. BBT is a surgical technique shown to provide efficient, precise separation of layers of the cornea in transplant patients; however, it is extremely challenging and leads to high rates of tissue perforation, with even experienced surgeons reporting 5?39% failure rates. This project leverages a technology for controlled separation of tissue layers to overcome the major barriers of LBT and BBT and enable adoption of partial thickness corneal transplant procedures. This proposal will test the hypotheses that this technology can provide high quality grafts that fit into existing clinical workflows and can enable safe, efficient, and standardized separation of corneal layers without complications. These studies, in collaboration with leading eye banks/corneal specialists, will advance device designs to ensure functionality, usability, manufacturability, and efficacy in human donor eyes.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.