PARIS--(BUSINESS WIRE)--Regulatory News:
Pixium Vision (Paris:PIX) (FR0011950641 - PIX), a company developing innovative bionic vision systems to enable patients who have lost their sight to lead more independent lives, announces today the world’s first successful human implantation and activation of PRIMA, its new generation miniaturized wireless photovoltaic sub-retinal implant, in a patient with severe vision loss from atrophic dry Age-related Macular Degeneration (AMD). The PRIMA Bionic Vision System successfully elicited visual perception. This enables the patient to start the re-education phase as per the trial protocol, which includes a 6-month follow-up and progress update.
This study is designed to evaluate the safety and performance of PRIMA in eliciting central visual perception among patients who have lost their central sight due to atrophic advanced dry-AMD. The study will recruit up to 5 patients with evaluation at 6-month follow-up, and longer-term follow-up to 36 months. Dr. Yannick Le Mer, pioneering ophthalmologist and retinal surgeon, performed the first PRIMA implantation as part of the feasibility clinical study1 of PRIMA in France being conducted at Fondation Ophtalmologique Rothschild and Hôpital des Quinze-Vingt in Paris.
“This first successful PRIMA implantation results from its rigorous development and its testing phases. The smooth recovery of the patient was enabled also by the elegance of the surgical technique. Successful activation was achieved one-month post implantation as per the protocol,” stated Dr. Le Mer, principal investigator of the study. “Following activation, the patient reported a first perception of light from the central zone where there was none previously. The patient now proceeds to the important re-education phase to learn to interpret the elicited light signals and evaluate the performance of the PRIMA system.”
Prof. Daniel Palanker, Stanford University, Dept. of Ophthalmology and inventor of PRIMA, said: “This first successful activation is a major milestone, validating PRIMA’s concept in patients with advanced dry AMD. The close collaboration between our team at Stanford University and Pixium Vision has been critical for successful development and testing of PRIMA. We will continue to advance the photovoltaic implants in our lab, seeking further increases in resolution and in quality of the visual perception.”
Khalid Ishaque, Chief Executive Officer of Pixium Vision, said: “In Pixium’s mission to create a world of bionic vision for those with vision loss from retinal dystrophies, the team and partners have delivered a major milestone in the development of its new generation bionic vision system. PRIMA harnesses breakthrough innovations and new possibilities to address a significant unmet need, for which we are concentrating initially in atrophic dry-AMD. We look forward to completing the feasibility phase in France and starting the FDA approved US feasibility study.”
ABOUT PRIMA
PRIMA is a miniaturized new generation totally wireless sub-retinal implant. The PRIMA implant is a micro photovoltaic chip of 2x2 millimeters and 30 microns thick, and is equipped with 378 electrodes. Implanted under the retina via a less invasive surgical procedure, it acts like a tiny solar panel that is powered by pulsed near infrared light through a miniaturized projector integrated the pair of glasses along with a mini-camera, worn by the implanted subject. PRIMA is designed to treat retinal dystrophies, initially atrophic dry Age-related Macular Degeneration (dry AMD), a significant unmet medical need with currently no proven therapeutic solution, and at later stage also Retinitis Pigmentosa (RP).
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 a clinical study1 in Human 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, the Hansen Experimental Physics Laboratory at Stanford University, 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.
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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
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Document filed with the AMF under number R16-033 on April 28, 2016 which
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IRIS®
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1 Feasibility 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
