SBIR Phase I: Corneal Tissue Restoration with Engineered Tissue

这个小型企业创新研究(SBIR)第一阶段项目包括减少角膜失明的经济负担，并推动美国的医疗器械制造业。视力丧失给社区造成了工资和医疗费用的损失。2018年，在北美，失明和MSVI(中重度视力障碍)的总成本为555.1亿美元。通过提供一种相当于S捐献角膜的治疗角膜失明的方法，这一创新将有助于恢复受角膜失明影响的患者的视力，提高他们贡献社会的能力，并减轻他们照顾者的负担。此外，通过为组织工程的一般过程做出贡献，工程化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。工程化角膜的发展还将有助于提升美国在角膜替代材料领域以及更广泛地说在工程组织研究领域的地位，并可能在医疗器械制造行业带来增长机会，从而提高美国的竞争力。这个小型企业创新研究(SBIR)第一阶段项目创造了一种新型的无细胞聚合物膜，用作角膜替代品。人工角膜将通过提供一种真正的替代供体角膜来替代全厚度角膜置换(也称为穿透性角膜移植)，从而将自己与其他人工角膜选择区分开来。人工角膜将由一种交联型聚合物膜组成，它将提供与眼组织的生物兼容性和类似于供体角膜的缝合性。此外，还将对薄膜进行特定的表面修饰，以防止环境和生物污染物的附着，从而保持其光学清晰度。这些改进将能够安全地整合到患者的眼睛中。新材料将在美学上等同于现有的供体角膜。与目前的人工角膜方案不同，人工角膜旨在提供一种真正的供体角膜替代品，可用作全厚度角膜置换的护理治疗标准，不存在通常与供体角膜组织相关的风险，也不需要冷藏或复杂的运输物流。该奖项反映了NSF的法定使命，并通过使用基金会的智力优势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.