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Pixium Vision Appoints Karine Chevrie, PhD, as Regulatory Affairs and Quality Director

July 8, 2015 1:00 AM EDT
  • Pixium Vision reinforces its team to prepare the launch of its bionic vision systems

PARIS--(BUSINESS WIRE)-- Regulatory News :

Pixium Vision (Paris: PIX) (FR0011950641 - PIX), a company developing innovative bionic vision systems to allow patients who have lost their sight to lead more independent lives, today announced the appointment of Karine Chevrie as Regulatory Affairs and Quality Director. Karine will lead the teams in charge of Regulatory Affairs and Quality to conduct the regulatory process prior to the commercial launches of the company’s products.

Khalid Ishaque, CEO of Pixium Vision, comments: « We are pleased to welcome Karine Chevrie at Pixium Vision. Karine’s exhaustive experience in regulatory affairs and her ability to prepare medical device launches are strong assets to successfully launch IRIS and establish Pixium Vision as a leader of vision restoration systems.”

Karine Chevrie has a PhD in Biochemistry and 20 years’ experience in the field of medical devices. During her career, she was notably in charge of regulatory strategies which contributed to obtaining CE marks and FDA approvals. She also built and managed quality management systems complying to ISO 13485 and 21CFR820 US regulation.

From 2006 to 2015, Karine Chevrie held the position of Regulatory Affairs and Quality Director at EOS Imaging. Previously, she was for 7 years in charge of medical devices that hold a biological risk at AFSSAPS (now ANSM). In that framework, she participated in several work groups at the European Commission.

About Pixium Vision (www.pixium-vision.com, @PixiumVision)

Pixium Vision is developing innovative Vision Restoration Systems (VRS) that aim to significantly improve the independence, mobility and quality of life of patients who have lost their sight. The Company harnesses the rapid advances in visual processing, microelectronics / nanoelectronics, optoelectronics, neurobiology and intelligent software algorithms. Pixium Vision’s VRS are associated with a surgical intervention as well as a rehabilitation period.

Clinical trials are currently underway with the VRS IRIS® in several centers in Europe. Patients have tolerated their implants well so far and improvements in visual perception have been observed. The results of these studies will be used to apply for CE mark. The approval of IRIS® is expected in 2015.

Pixium Vision is also developing PRIMA, a sub retinal implant currently in preclinical trial. The Company plans to begin clinical trials of PRIMA in Europe in 2016.

Pixium Vision is listed on Euronext (Compartment C) in Paris.ISIN: FR0011950641; Mnemo: PIXIRIS® is a trademark of Pixium-Vision SA

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 Documents de Base filed with the AMF under number I. 14-030 on May 12, 2014 and Chapter 2 "Risk Factors related to the Offer" in the prospectus, which can be found on the websites of the AMF - AMF (www.amf-france.org) and of Pixium Vision (www.pixium-vision.com).

Pixium Vision
Pierre Kemula, CFO, +33 1 76 21 47 30
[email protected]
@PixiumVision
or
Investor Relations
Citigate Dewe Rogerson
Lucie Larguier – Laurence Bault, +33 1 53 32 84 78
[email protected]
or
Relations Presse hors investisseurs
Newcap Media
Annie-Florence Loyer – Nadège Le Lezec
[email protected]
[email protected]

Source: Pixium Vision



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