LOS ANGELES –(BUSINESS WIRE)
Second Sight Medical Products, Inc. (NASDAQ: EYES) (“Second Sight” or “the Company”), a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision to blind individuals, today announced that the Company has received a $1.6 million grant (with the intent to fund $6.3 million over five years subject to annual review and approval) from the National Institutes of Health (NIH) to fund the “Early Feasibility Clinical Trial of a Visual Cortical Prosthesis” that commenced in January 2018.
The NIH grant funds ongoing and planned clinical activities and will be used to:
Conduct and support clinical testing of five subjects implanted with the Orion™ Cortical Visual Prosthesis (Orion);
Submit and obtain Investigational Device Exemption approval from the U.S Food and Drug Administration (FDA), and Institutional Review Board approval for a larger and final clinical study as approved by FDA;
Evaluate Orion reliability;
Create and test spatial maps with multiple spatial mapping methods in up to five patients;
Establish and validate a fitting process for Orion; and
Demonstrate improvements in the Functional Low-Vision Observer Rated Assessment (FLORA).
“We are delighted to be working with the researchers at the NIH and are deeply appreciative of this grant as we aim to advance Orion and work toward commencing a final clinical study to gain FDA approval. With this grant, we are one step closer to bringing Orion to a broader market that potentially treats a segment of the millions of blind individuals worldwide who have no other option,” stated Will McGuire, President and CEO of Second Sight.
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