NASA SBIR 2019-II Solicitation

Proposal Summary

 19-2- H8.01-3699
 Low Earth Orbit Platform Utilization and Microgravity Research
 Implementation of a Layer-by-Layer Manufacturing Apparatus for the Assembly of Protein-Based Retinal Implants in Low Earth Orbit
SMALL BUSINESS CONCERN (Firm Name, Mail Address, City/State/Zip, Phone)
LambdaVision, Inc.
400 Farmington Avenue
Farmington, CT 06032
(860) 679-2558

PRINCIPAL INVESTIGATOR (Name, E-mail, Mail Address, City/State/Zip, Phone)
Nicole Wagner
400 Farmington Avenue
Farmington, CT 06032, CT 06032 - 1913
(774) 280-0525

BUSINESS OFFICIAL (Name, E-mail, Mail Address, City/State/Zip, Phone)
Dr. Jordan Greco
400 Farmington Avenue
Farmington, CT 06032, CT 06032 - 1913
(860) 690-5713

Estimated Technology Readiness Level (TRL) :
Begin: 4
End: 6
Technical Abstract (Limit 2000 characters, approximately 200 words)

LambdaVision has developed a protein-based retinal implant to restore vision to the millions of people blinded by retinal degenerative diseases, including retinitis pigmentosa and age-related macular degeneration. Preclinical evaluation of the technology demonstrated the ability to reproducibly stimulate degenerated retinal tissue and safely insert the implant into the subretinal space of both rats and pigs. The implants are manufactured using a layer-by-layer (LBL) assembly technique, in which alternating layers of the light-activated protein, bacteriorhodopsin, and a polycation are sequentially deposited onto a film. However, the current terrestrial LBL approach is influenced by gravity, in which sedimentation and gradients of solutions interfere with the quality of the implants. We hypothesize that manufacturing in a microgravity environment will improve the quality of the films and, as a result, will enhance stability and performance for future preclinical and clinical trials. A pilot manufacturing trial was carried out on the ISS via SpaceX CRS-16, which resulted in the proof of concept of creating multilayered thin films using a LEO platform. Subsequently, a Phase I SBIR effort allowed us to perform a series of parameterization experiments for follow-on spaceflight optimization. In this Phase II proposal, we will build on the terrestrial-based findings to achieve the following: (1) the completion of a LBL prototype with optimized parameters for implementation in microgravity, (2) the design of a chamber configuration that supports scale up for nonclinical non-GLP toxicity studies in a large animal model, and (3) a proof of concept of utilizing the LBL microgravity device for additional applications beyond the proposed use in vision restoration. This Phase II effort fits in to NASA’s strategic plan for commercialization in LEO to build a sustainable production pipeline for this technology and for forthcoming technologies in the biomedical sector.

Potential NASA Applications (Limit 1500 characters, approximately 150 words)

This Phase II SBIR establishes the capabilities required to support LEO commercialization of protein-based retinal implants. The implant targets patients with retinal degeneration, a leading cause of blindness for millions around the globe, including astronauts exposed to extended-duration spaceflight. The work outlined will support a new sector in the Space economy, which utilizes the impact of microgravity on physical systems to improve current production methods for patient therapies. 

Potential Non-NASA Applications (Limit 1500 characters, approximately 150 words)

An enhanced layer-by-layer manufacturing process can improve the homogeneity, orientation, and stability of multilayered thin films for broad applications, including retinal implants, photovoltaic cells, chemical sensors, drug delivery systems, and tissue engineering. Efficient ordering of biomaterials is of interest to scientists with technologies across therapeutic and biomedical sectors.

Duration: 24

Form Generated on 05/04/2020 06:31:12