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Press Release

Pixium Vision: presentation of the first clinical results with PRIMA, its wireless implant, in patients with Dry-AMD

Pixium Vision
Posted on: 18 Sep 18

  Pixium Vision announces the presentation of the first clinical results with PRIMA, its wireless implant, in patients with atrophic Dry-AMD

EURETINA Annual Conference

Vienna, Austria 20 - 23 September 2018

Paris, France. September 18, 2018 - 7.00 AM CEST - Pixium Vision (FR0011950641 - PIX), a bioelectronics company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, today announced that the first clinical results from the French feasibility trial of PRIMA, its novel miniature wireless photovoltaic sub-retinal implant, will be presented during the 18 th annual congress EURETINA (European Society of Retina Specialists), to be held in Vienna (Austria) from September 20 to 23, 2018.

The presentation will be given by the principal investigator of the feasibility study, Dr. Yannick Le Mer (Fondation Ophtalmologique A. de Rothschild, Paris - France) on Friday, September 21st, from 5.40PM.

The abstract is accessible through the EURETINA conference website:

  « Subretinal implantations of PRIMA wireless photovoltaic chip, a new surgical technique for atrophic dry age-related macular degeneration: Technical feasibility and early results .  »

Pixium Vision recently announced that PRIMA has been successfully activated in all consecutive five implanted patients afflicted by vision loss due to atrophic Dry-AMD and included in the French feasibility study. This study [1] with PRIMA is a 36-month, 5-patient clinical feasibility study, designed to evaluate the safety and function of the wireless photovoltaic sub-retinal PRIMA chip in eliciting visual light perception.

The full set of 6-month interim results of the French feasibility study with all 5 patients (currently with follow-up period between 2 and 9 months) are expected by the end of 2018. This will enable the design of the protocol for the larger multi-centric European pivotal study to commence in 2019, required for the CE-mark.


Contacts

Pixium Vision

 

Didier Laurens, CFO
investors@pixium-vision.com
+33 1 76 21 47 68
Media Relations
Newcap Media
Annie-Florence Loyer - afloyer@newcap.fr
+33 1 44 71 00 12 / +33 6 88 20 35 59
Léa Jacquin - ljacquin@newcap.fr
+33 1 44 71 94 94
US Investor Relations
ICR
David Clair
david.clair@icrinc.com
+1 646 277 12 66

 

ABOUT PRIMA

PRIMA is a new generation miniaturized and totally wireless sub-retinal implant. The PRIMA implant is a micro photovoltaic chip of 2x2 millimeters wide and 30 microns thick, equipped with 378 electrodes. Implanted under the retina via a minimal invasive surgical procedure, it acts like a tiny solar panel that is powered by pulsed near infrared light through a miniaturized projector integrated in a pair of augmented reality-like glasses, along with a mini-camera, worn by the implanted subject. PRIMA is designed to compensate for severe vision loss from retinal dystrophies, initially atrophic dry Age-related Macular Degeneration (dry AMD), a significant unmet medical need with currently no curative therapeutic solution, and at later stage also Retinitis Pigmentosa (RP).

ABOUT AGE-RELATED MACULAR DEGENERATION (AMD)

Age-related macular degeneration is the leading cause of severe vision loss and legal blindness in people over the age of 65 in North America and Europe, impacting an estimated 12 to 15 million people worldwide which is continuously growing due to ageing population. There are two forms of AMD, the wet form, representing ~20% of AMD, where treatment like anti-VEGF injections is available slow down the disease progression, and the dry form, representing ~80% of AMD, where there is currently no curative treatment available. More than 4 million patients are afflicted with advanced dry AMD In Europe and the United States. Patients suffering from this retinal disorder start by losing their central vision (responsible for visual precision and details, for example, required for reading and face recognition) and progressively become blind.

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. Following the CE mark for its first bionic retinal implant systems, IRIS ® II, Pixium Vision is now conducting clinical studies with PRIMA, its new generation sub-retinal miniaturized photovoltaic wireless implant system, for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates closely with academic and research partners spanning across the prestigious Vision research institutions including the Institut de la Vision in Paris, Stanford University in California, Moorfields Eye Hospital in London, and Institute of Ocular Microsurgery (IMO) in Barcelona. The company is EN ISO 13485 certified and qualifies as "Entreprise Innovante" par Bpifrance.


For more information, please visit:   www.pixium-vision.com ;
And follow us on: @PixiumVision;   www.facebook.com/pixiumvision
               www.linkedin.com/company/pixium-vision

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] Study of Compensation for Blindness with the PRIMA System in Patients with Dry Age-Related Macular Degeneration (PRIMA FS) https://www.clinicaltrials.gov/ct2/show/NCT03333954

Euretine GB


This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.

The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Pixium Vision via GlobeNewswire
HUG#2216525
GlobeNewswire
globenewswire.com

Last updated on: 19/09/2018

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