Submission of the Clinical Investigation Protocol to Ethics Committee and the AEMPS

30 November 2023

Submission of the Clinical Investigation Protocol and all documents needed for authorization to conduct the First In Human Clinical trial to Ethics Committee and the AEMPS.

Working with the Institute of Micro Ocular Surgery (IMO), the hospital where the First In Human clinical trial will be conducted, the Clinical Investigation Study Protocol “REMKERA Version 1.0” and all the other documents related to the GROSSO implant have been submitted to the Comité de ética de la Investigación del Hospital Universitario de Bellvitge (IDIBELL) Ethics Committee on November 24, 2023 and to Spanish regulatory authority “AEMPS” on November 28, 2023.

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