Wednesday, August 29, 2018 4:19:21 PM
"Based on progress made to-date, the Company currently expects the completion of the Functional Unit phase in calendar 4Q 2018 and the Verified Unit phase in calendar 1Q 2019. The Company believes that the miniaturization, imaging quality and cost reduction goals for the i/Blue Imaging System will be achieved as Optel optimizes the system and works toward commercialization."
"Necessary documents to begin the FDA process, including clinical study recommendation, are being prepared for submission. The timing of the clinical studies is tied to the final verification of the i/Blue Imaging System and is currently anticipated to begin late calendar 1Q 2019 or during calendar 2Q 2019. Depending on the FDA device classification and schedule, the Company is planning for potential commercialization in calendar year 2020."
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