SBIR Phase I: Corneal Tissue Restoration with Engineered Tissue

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.