SBIR Phase I: Corneal Tissue Restoration with Engineered Tissue

这个小企业创新研究（SBIR）一期项目包括减轻角膜失明的经济负担和推动美国医疗器械制造业的发展。视力丧失使社区损失了工资和医疗费用。2018年，北美失明和中度和重度视力障碍（MSVI）的总成本为555.1亿美元。通过提供一种相当于捐赠角膜的治疗角膜失明的方法，这项创新将有助于角膜失明患者恢复视力，提高他们为社会做出贡献的能力，并减轻照顾他们的人的负担。此外，通过促进组织工程的一般进程，工程角膜将有助于促进供体组织替代品领域的研究，这将有助于整个社会个人的福祉。工程角膜的发展也将有助于提升美国在角膜替代材料领域的地位，更广泛地说，在工程组织研究领域，并可能为医疗器械制造业带来增长机会，从而提高美国的竞争力。这个小企业创新研究（SBIR）的第一阶段项目创造了一种新型的无细胞聚合物膜，用于角膜替代品。人工角膜将区别于其他人工角膜选择，因为它提供了一种真正的替代供体角膜的全层角膜置换术（也称为穿透性角膜移植术）。人造角膜将由交联聚合物膜组成，它将提供与眼部组织的生物相容性和类似于供体角膜的可缝合性。此外，特定的表面修饰将被添加到膜上，通过防止环境和生物污染物的粘附来保持其光学清晰度。这些改进将使其能够安全地集成到患者的眼睛中。这种新材料在美学上与现有的供体角膜相当。与目前的人工角膜选择相比，人工角膜旨在提供一个真正的替代供体角膜，可以作为全层角膜替代的标准护理治疗，没有供体角膜组织通常相关的风险，不需要冷藏或复杂的运输物流。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

This Small Business Innovation Research (SBIR) Phase I project includes reduces the financial burden of cornea blindness and advances the medical device manufacturing industry in the US. Vision loss costs communities in lost wages and medical expenses. In 2018, the combined cost for blindness and MSVI (moderate and severe vision impairment) was $55.51 billion in North America. By providing a treatment for cornea blindness equivalent to s donor cornea, this innovation would help restore the vision of patients affected by corneal blindness, improve their ability to contribute to society, and lower the burden on their caretakers. In addition, by contributing to the general process of tissue engineering, the engineered cornea will help foster research in the field of alternatives to donor tissues, which will contribute to the well-being of individuals in society as a whole. The development of engineered cornea would also help advance the position of the US in the cornea replacement material field and more generally in the engineered tissue research field and could result in growth opportunities in the medical device manufacturing industry, therefore increasing US competitiveness.This Small Business Innovation Research (SBIR) Phase I project creates a novel acellular polymer membrane for use as a cornea substitute. The artificial cornea will differentiate itself from other artificial cornea options by offering a true alternative to donor cornea for full thickness cornea replacement (also known as penetrating keratoplasty). The artificial cornea will consist of a crosslinked polymer membrane that will provide biocompatibility with ocular tissues and suturability similar to a donor cornea. In addition, specific surface modifications will be added to the membrane to maintain its optical clarity, by preventing the adhesion of environmental and biological contaminants. These modifications will enable secure integration into the patient’s eye. The new materials will be aesthetically equivalent to existing donor cornea. By contrast to current artificial cornea options, the artificial cornea aims to provide a true replacement to donor cornea that can be used as a standard of care treatment for full thickness cornea replacement, without the risks generally associated with donor cornea tissue and without the need for refrigeration or complicated transport logistics.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.