[October 19, 2017] |
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Pixium Vision Receives Approval for First-in-Human Clinical Trial of PRIMA, Its Miniaturized Sub-Retinal Implant
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 that its
next-generation miniaturized wireless sub-retinal implant, PRIMA, to
restore vision in patients affected by retinal dystrophies, received
authorization from the French regulatory agency, Agence Nationale de
Sécurité du Médicament et des Produits de santé (ANSM), to
start a feasibility clinical study in patients with advanced dry
age-related macular degeneration (dry-AMD (News - Alert)).
Khalid Ishaque, Chief Executive Officer of Pixium Vision,
commented: "The approval of the clinical study is a
significant advance for the PRIMA system, our next generation wireless
sub-retinal implant system, as well as for Pixium Vision. Conceived
initially by the researchers at Stanford University, and successfully
developed through to clinical stage by our team at Pixium Vision in
close collaboration with numerous physicians and scientists, PRIMA
enters an exciting phase of its development, with a first patient
expected to be implanted before year end. With aging population
dynamics, advanced dry-AMD is a leading cause of irreversible vision loss1
with currently estimated over 4 million people without approved
treatment option making it a significant unmet medical need."
The clinical study entitled "Feasibility Study of Compensation for
blindness with the PRIMA system in patients with dry age related macular
degeneration", is designed to evaluate the tolerance of PRIMA and to
demonstrate the evoked central visual perception among patients who have
lost their sight due to atrophic advanced dry-AMD. The study is planned
to recruit 5 patients with interim evaluation at 6-month follow-up and
longer term follow-up to 36 months. The study will be conducted at Fondation
Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in
Paris with Dr. Yannick Le Mer, vitreoretinal surgeon and
ophthalmologist, as principal investigator.
In parallel, Pixium Vision actively pursues its constructive discussions
with the US Food and Drug Administration (FDA), in order to also prepare
the feasibility study with PRIMA in the US.
ABOUT PRIMA
PRIMA is a miniaturized new generation implant totally wireless. The
PRIMA implant is a micro photovoltaic chip of 2 millimeters and 30
microns thick, PRIMA is equipped with 378 electrodes. Implanted under
the retina via a less invasive surgical procedure, implant converts
pulsed near infra-red invisible light signal received from the external
glasses with an integrated mini-camera into electrical signals
transmitted to the brain via the optic nerve. PRIMA is designed to treat
retinal dystrophies, prticularly aiming to treat advanced atrophic
dry-AMD, the most prevalent form of Age-related Macular Degeneration,
thanks to miniaturization and aimed to preserve patient's residual
peripheral vision. Prima is also intended to be evaluated at a later
stage for treatment of vision loss from Retinitis Pigmentosa.
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 has been authorized to start
clinical study in Human for PRIMA, a sub-retinal miniaturized wireless
implant system. 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; And
follow us on: Twitter (News - Alert) @PixiumVision;
Facebook (News - Alert) www.facebook.com/pixiumvision LinkedIn (News - Alert)
www.linkedin.com/company/pixium-vision
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 (News - Alert): 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 http://www.thelancet.com/journals/langlo/article/PIIS2214-109X(17)30393-5/fulltext
View source version on businesswire.com: http://www.businesswire.com/news/home/20171018006357/en/
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