Report

Pixium Vision - ANSM approval to start PRIMAvera pivotal study

Pixium Vision announced on 20 November that it has received approval from the French regulatory health authority, ANSM, to start its PRIMAvera European pivotal study of its Prima Bionic Vision System (BVS) in patients with dry age-related macular degeneration with geographic atrophy (GA-AMD), a largely unmet market indication. This is an important milestone for Pixium as we believe the PRIMAvera European registration study may provide top-line 12-month data in H222, supporting our estimate of potential CE mark and European launch in H223.
Underlying
Pixium Vision SA

Pixium Vision SA is a company that specializes in sensorial neuromodulation. Co. is also collaborating with scientific groups and clinicians at research institutes and clinical centers around the world, including Stanford University (USA). Co. is developing and aims to commercialize Bionic Vision Systems (BVS) – namely active implantable medical devices to treat blindness caused by degeneration of photoreceptor cells in the retina.

Provider
Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Sean Conroy

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