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SBIR Phase II: Development of a novel, highly efficient Descemet's Membrane Endothelial Keratoplasty preparation device expands the donor pool

Award Information
Agency: National Science Foundation
Branch: N/A
Contract: 2212687
Agency Tracking Number: 2212687
Amount: $1,000,000.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: BM
Solicitation Number: NSF 21-565
Solicitation Year: 2021
Award Year: 2023
Award Start Date (Proposal Award Date): 2022-12-01
Award End Date (Contract End Date): 2024-11-30
Small Business Information
3361 Chestnut Ave
Baltimore, MD 21211
United States
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: Yes
Principal Investigator
 Katherine Solley
 (860) 248-1624
Business Contact
 Katherine Solley
Phone: (860) 248-1624
Research Institution

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. _x000D_
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._x000D_
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.

* Information listed above is at the time of submission. *

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