(1) To obtain FIH approval to be conducted in Taiwan

(2) To obtain the 1-year clinical data

(3) To obtain the approval of EFS IDE conducted in US

After obtaining 1-year outcome of EFS IDE study in US and with enough confidence gained, we'll launch the pivotal study (3 years) for US FDA approval (~6 months PMA review) of going into commercialization. We will go for the breakthrough device designation (BDD) in US FDA once we get good FIH effectiveness data to speed up the FDA review process.

The specification is for the initial EFS IDE application since the risk/benefit ratio needs to be controlled. (Patients with worse vision have less to lose in the EFS IDE trial.) Once the effectiveness data is obtained through EFS IDE, we’ll adjust accordingly for the pivotal study. Additionally, off-label application can be used if doctors are convinced that it’s beneficial to patients based on our clinical data. The device itself allows a visual acuity of 1.0 logMAR which covers ~48% GA patients, and it’s ~80,000 patients annually in the US alone.

The fitting process using the fitting console covers physical characterizations and perceptual characterizations; the former includes photonics and impedance characterizations to map out the in vivo characteristics of the implanted chip/tissue combination, and the perceptual characterization determines the threshold to induce visual percepts within each tested receptive field using psychophysical methods that involve subjective feedback of the patient. After completing the fitting process, a customized setting of 4,000 parameters will be generated for each patient, and stored in their own Eyeglasses to provide configurations suitable for them.