Forfait Innovation decision postponed
Pixium announced on 24 May 2017 that the French Haute Autorité de Santé (HAS) has requested additional clinical data before agreeing to provide exceptional reimbursement under the Forfait Innovation (FI) programme for Pixium’s Iris II implant system. The HAS agreed that the Iris II meets the critical FI eligibility criteria of providing a sufficiently novel and innovative treatment for a significantly unmet medical need (patients severely visually impacted by retinitis pigmentosa). Pixium now plans to provide interim six-month data from its ongoing 10-patient European Iris-II study, which should be available in Q317, to fulfil this requirement. Hence we believe a decision from HAS on potential Iris-II reimbursement under FI is not likely before late Q317 or early Q417.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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