SBIR-STTR Award

Retinal diseases such as macular degeneration, retinal dystrophies, and retinitis pigmentosa (RP) afflict more than 8.5 million Americans. As the population ages, this number will grow significantly, and many people will suffer from vision loss due to degeneration of photoreceptors and/or retinal pigment epithelium (RPE). Although vitamin or gene therapies may be helpful in early-stage retinal diseases, once photoreceptors are lost, replacement via retinal transplantation or implantation of microchips is the only treatment option for the end stage. The overall goal of this fast-track project is to develop a retina implantation instrument kit that will allow retinal surgeons to harvest, dissect, and transplant sheets of undifferentiated fetal retinal tissue with its RPE and then transplant these cografts into the subretinal space. These tools consist of an implantation instrument (a hand piece and flexible, non-sticky nozzles), a special microscissors to allow easy harvest and dissection of consistently good preparations of retina/RPE sheets, and a dilator probe to allow easier and more accurate insertion of the implantation instrument into the eye. Phase I will focus on proving the capability of the implantation instrument to provide the precise handling required, while demonstrating nozzle sizes suitable for use in the transplant of retina/RPE sheets. The versatile tools in the kit will be readily adaptable and highly marketable for use in other transplant applications such as fundamental laboratory studies or for delivery of other material to the retina.

Thesaurus Terms:
biomedical equipment development, clinical biomedical equipment, embryo /fetus tissue transplantation, eye surgery, retina, surgery material /equipment biomedical equipment safety, implant, retinal pigment epithelium bioengineering /biomedical engineering, biotechnology, clinical research, human tissue, medical implant science

The overall goal of this project is to develop a retina implantation instrument kit that will allow: 1) retinal surgeons to harvest, dissect, and transplant sheets of undifferentiated fetal retinal tissue with its retinal pigment epithelium (RPE) and then transplant these cografts into the subretinal space, 2) other transplant protocols for microchips and RPE/choroid patches, and 3) delivery of encapsulated slow-releasing drugs or cell suspensions. The tools in the kit consist of an implantation instrument (a hand piece and nozzles that fit over mandrels), a special microscissors to allow easy harvest and dissection of consistently good preparations of retina/RPE sheets, and a dilator probe to allow easier and more accurate insertion of the implantation instrument into the eye. Results of the Phase I research demonstrate the implantation instrument provides the precise handling and maneuverability required for the transplant procedure and that the nozzles can load and unload tissue without damage to either the cograft sheets or recipient eye. The goal of Phase II is to develop a production-ready retina implantation instrument kit suitable for clinical trials and commercial manufacture and perform testing in preparation for Food and Drug Administration (FDA) approval. A production-ready hand piece will be developed, along with a standardized production process for disposable nozzles and mandrels for cograft implantation. In an extension of the design, prototypes of nozzles/mandrels suitable for other applications will be developed. The other tools in the kit, a furrowed-edge microscissors and a dilator probe, will also be developed. Testing will then be performed in preparation for FDA approval. Following a Phase III effort that includes FDA approval and multi-center clinical trials, a commercial retina implantation instrument kit will be available for transplant applications ranging from fetal cografts to microchips to RPE/choroid patches. Retinal diseases such as macular degeneration, retinal dystrophies, and retinitis pigmentosa (RP) afflict more than 8.5 million Americans. As the population ages, this number will grow significantly, and many people will suffer from vision loss due to degeneration of photoreceptors and/or RPE. With surgeons equipped with the versatile tools in this kit and trained in their use, retinal transplantation will emerge as a near-term, viable technique for the growing number of patients in need of vision preservation and restoration. Retinal diseases such as macular degeneration, retinal dystrophies, and retinitis pigmentosa afflict more than 8.5 million Americans. As the population ages, this number will grow significantly, and many people will suffer from vision loss due to degeneration of photoreceptors and/or retinal pigment epithelium. With surgeons equipped with the versatile tools in this kit and trained in their use, retinal transplantation will emerge as a near- term, viable technique for the growing number of patients in need of vision preservation and restoration