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Home>Pixium Vision Announces Updates on Its Epi-retinal IRIS®II Bionic Vision System

Pixium Vision Announces Updates on Its Epi-retinal IRIS®II Bionic Vision System

Pixium Vision Announces Updates on Its Epi-retinal IRIS®II Bionic Vision System

09/27/2017

Pixium Vision Announces Updates on Its Epi-retinal IRIS ® II Bionic Vision System

Regulatory News:

Pixium Vision (FR0011950641 - PIX) (Paris:PIX), a company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, today announces updates on its epi-retinal IRIS®II system, CE marked for outer retinal degeneration, including Retinitis Pigmentosa.

  • The 6-month follow-up of clinical safety and performance further demonstrates that IRIS®II improves visual performance of the implanted patients and has a favorable safety profile. A full set of interim 6 months results was presented during the 10th International Eye & the Chip1 Conference in Detroit (USA), 24-26 September 2017,
  • A shorter than expected lifespan of the device was noticed in this set of patients. This presents no risk to the implanted patients as the innovative exchangeable design of IRIS®II allows for a replacement of the device. A first replacement was already completed successfully during the clinical study. Pixium Vision has nonetheless decided to temporarily halt new implantations in order to validate corrective measures with regulatory bodies, including a revision to the surgical method already identified as a potential solution,
  • The first commercial IRIS®II implant carried out in Spain was successfully activated recently,
  • In France, IRIS®II was granted Forfait Innovation by the French Haute Autorité de Santé (HAS) on September 20, 2017.

ABOUT PIXIUM VISION

Pixium Vision’s Mission is to create a world of bionic vision for those who have lost their sight, enabling them to regain partial visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention as well as a rehabilitation period.

The company is developing two bionic retinal implant systems. IRIS®II, the company first bionic system, obtained CE mark in July 2016. In parallel, Pixium Vision has recently completed the pre-clinical study phases for PRIMA, a sub-retinal miniaturized wireless photovoltaic implant platform, and is planning to initiate first-in-human trials.

Pixium Vision collaborates closely with academic and research partners spanning across the prestigious Vision research institutions including the Institut de la Vision in Paris, the Hansen Experimental Physics Laboratory at Stanford University, and Moorfields Eye Hospital in London. The company is EN ISO 13485 certified.

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