PARIS--(BUSINESS WIRE)--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.
Pixium Vision is qualified “Entreprise Innovante” par Bpifrance
For more information, please visit: www.pixium-vision.com;
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Pixium Vision is listed on Euronext Paris (Compartment C). Pixium Vision shares are eligible for the French tax incentivized PEA-PME and FCPI investment vehicles.
Pixium Vision is included in the Euronext CAC All Shares index
Euronext ticker: PIX - ISIN: FR0011950641 – Reuters: PIX.PA – Bloomberg: PIX:FP
Disclaimer:
This press release may expressly or implicitly contain forward-looking statements relating to Pixium Vision and its activity. Such statements are related to known or unknown risks, uncertainties and other factors that could lead actual results, financial conditions, performance or achievements to differ materially from Vision Pixium results, financial conditions, performance or achievements expressed or implied by such forward looking statements.
Pixium Vision provides this press release as of the aforementioned date and does not commit to update forward looking statements contained herein, whether as a result of new information, future events or otherwise.
For a description of risks and uncertainties which could lead to discrepancies between actual results, financial condition, performance or achievements and those contained in the forward-looking statements, please refer to Chapter 4 "Risk Factors" of the company’s Registration Document filed with the AMF under number R16-033 on April 28, 2016 which can be found on the websites of the AMF - AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).
IRIS® is a trademark of Pixium-Vision SA
1 https://www.henryford.com/hcp/research/vision/research-congress/eye-chip