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

SBIR II 期：开发新型高效后弹力层内皮角膜移植术准备装置，扩大供体库

• 批准号: 2212687
• 负责人: Katherine Solley
• 金额: $ 100万
• 依托单位: EYEDEA MEDICAL, INC
• 依托单位国家: 美国
• 项目类别: Cooperative Agreement
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2212687&HistoricalAwards=false
• 关键词: SBIR; Phase; II; Development; novel

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.

该小企业创新研究 (SBIR) 第二阶段项目的更广泛影响/商业潜力涉及超过 2500 万人等待角膜移植以恢复视力的重大、未满足的临床和商业需求，导致角膜失明率增加。身体伤害、精神障碍、社会孤立和认知能力下降的风险，导致预期寿命缩短 15 年以上。幸运的是，95% 的角膜疾病可以通过移植进行治疗。为超过 90% 的角膜疾病患者提供最佳的临床结果；然而，安全有效地分离角膜层以准备角膜移植物和进行移植的难度导致了这些手术的利用不足。将用于角膜移植准备和角膜移植手术中组织分离的一次性辅助装置商业化，有可能提高眼库和眼科医生的效率，增加角膜移植的机会，并改善这些手术的结果。该小型企业创新研究 (SBIR) 第二阶段项目涉及开发新型、一流的标准化移植物准备和辅助手术设备，以节省时间和资本，改善患者治疗效果并进入每年价值 3.4 亿美元的全球市场。角膜移植中的液泡 (LBT) 和大泡技术 (BBT) 是一种移植物准备技术，可在几分钟内从所有供体眼睛中准备好移植物，但难度更大；并且很少被眼睛使用BBT 是一种可以为移植患者提供高效、精确的角膜层分离的手术技术；然而，它极具挑战性，并且会导致较高的组织穿孔率，即使是经验丰富的外科医生也报告失败率为 5-39%。该项目利用组织层受控分离技术来克服 LBT 和 BBT 的主要障碍，并实现部分厚度角膜移植手术的采用。该提案将测试该技术可以提供适合现有临床工作流程的高质量移植物的假设。并且可以使安全，这些研究与领先的眼库/角膜专家合作，将推进设备设计，以确保人类捐赠眼睛的功能、可用性、可制造性和功效。该奖项反映了 NSF 的法定使命和通过使用基金会的智力价值和更广泛的影响审查标准进行评估，该项目被认为值得支持。