Bionic Sight, Inc.

Expanded Access Intelligence

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Reagan-Udall Foundation Insights

Company
Bionic Sight, Inc.
Expanded Access Website
Additional Information

Available Therapies via Single-Patient EA Bionic Sight’s technology focuses on restoring sight to patients with advanced stage blindness due to retinal degenerative diseases. Our lead product, BS01, is currently being investigated in a Phase I/II, open label study in patients with retinitis pigmentosa. Currently, Bionic Sight does not offer an expanded access program for BS01 for retinitis pigmentosa. Given the current stage of our development program, we believe that participation in our clinical trial is the most appropriate way to access our investigational therapy. We believe that access to BS01 should be limited to controlled clinical trials until such time as its safety and efficacy have been determined and confirmed by regulatory authorities. Consistent with the 21st Century Cures Act, Bionic Sight may revise this policy at any time. Last updated: January 2025

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