- Pixium cleared to start EU Prima feasibility study
Pixium has received clearance from the French regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé, or ANSM) to start a feasibility study of its Prima sub-retinal bionic vision system (BVS) on up to five patients with advanced Dry-ARMD. It plans to complete the first implantation before YE17, and obtain six-month study data in H218. If results are positive, Pixium expects to start an EU pivotal study in H119. We have reinstated our Prima probability of success estimate in our model to 12.5% (from 10%), leading to an increase in our pipeline rNPV to €82.6m (from €63.0m, previously).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.
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