Periodic Reporting for period 1 - SYMBIOSE (Unaided Sharp and Continuous Vision in All Daily Activities) Reporting period: 2020-10-01 to 2021-09-30 Summary of the context and overall objectives of the project CRISTALENS INDUSTRIE - a French SME specialized in intraocular implants for cataract and refractive surgery - joined in October 2020 the club of companies chosen by the European Commission in its “HORIZON 2020” project.The natural crystalline lens, which is located behind the iris of the human eye, ensures focus for sharp vision. As the lens ages, it hardens and becomes opaque, gradually losing its transparency. The person then suffers from cataract and his/her vision deteriorates: blurred vision, poor contrasts perception, altered vision of colours, among other effects. Cataract is the first cause of blindness in the world.As for presbyopia, all people over the age of 50 are more or less affected! Presbyopia is caused by a loss of elasticity of the lens. The symptoms are mainly a growing difficulty in seeing close objects. Presbyopia can be partially corrected with corrective lenses (glasses or contact lenses), while cataracts can only be treated by surgery to replace the natural lens with an Intraocular Lense, making then all patients operated from cataract becoming presbyopic.Current Intraocular Lenses suffer from important limitations. Patients must use glasses after surgery and have to adapt their activities to their vision. They can’t deal with the multiple visual signals that surround us all day long.CRISTALENS product portfolio aims to give back a sharp and continuous vision, from near to intermediate, to people being operated for cataracts. The goal is - as much as possible - to help the patients to break free from their glasses and to enjoy their daily activities without the need to adapt to their distance of vision.Symbiose®, thanks to its “Binocular Phase Continuity” patented technology, is designed to restore clear binocular vision to cataract patients for continuous sight from 40 to 90 cm, without any compromises on distance vision.This project aims to allow the Breton SME CRISTALENS INDUSTRIE to ease its international expansion strategy built upon its Artis Symbiose® by demonstrating the performance of the complete system through several clinical studies, preparing the scale-up to ensure volumes and capacity to supply the stocks, passing regulatory barriers and securing the appropriate intellectual property. Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far Since the start of the H2020 program, we have launched a total of 3 clinical studies. The first clinical study has started with already 10 patients enrolled. The clinical protocol for a second study is being reviewed while for the third study, the protocol has been signed and the initiation visit has been completed, with patient enrollment on the verge of starting.Our Industrialization team is currently working on the automation aspect of the machining, on the development of applications to automate the monitoring and the validation of the process, and on a new method of manufacturing Intraocular Lenses.Regarding intellectual property, our first patent [“Assembly consisting of a pair of multifocal ocular implants”] has been filed in 12 countries worldwide and 15 countries in Europe.Our concept SYMBIOSE is now registered and distributed in 27 countries. Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far) By 2024, a total of 6 clinical studies will be launched, all the applications currently underway will be implemented and we will be in a phase of trials and qualifications on the new method of IOLs manufacturing.SYMBIOSE will be registered and distributed in approximately 55 countries around the world. Détail ARTIS SYMBIOSE Vision binoculaire ARTIS SYMBIOSE Logo entreprise ARTIS SYMBIOSE
