Pixium Vision Announces Publication of Peer-Reviewed Clinical Data of the Prima System in Dry AMD in the Journal of Neural Engineering

/EIN News/ — Vision Pixium announces the publication of peer-reviewed clinical data of the Prima system in dry AMD in the Neural Engineering Journal

• The distance between the implant and the target cells was stable on long-term follow-up
• No significant change in retinal thickness after an initial phase of minor thinning

Paris, France, October 11, 2022 – 07:00 CET – Pixium Vision SA (Euronext Growth Paris – FR0011950641; Mnemo: ALPIX), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live a more independent life, announces today today the publication of a paper in the Neural Engineering Journal describing further data from its Prima system, a photoreceptor photoreceptor surrogate enabling simultaneous use of central and peripheral prosthetic natural vision, implanted in human patients with atrophic dry age-related macular degeneration (AMD) to restore partially their vision.

The peer-reviewed article in the Neural Engineering Journal, titled “Long-term Observations of Macular Thickness after Subretinal Implantation of a Photovoltaic Electronic Prosthesis in Patients with Dry Age-related Macular Degeneration”, authored by Mahiul MK Muqit, Yannick Le Mer, Frank Holz and José-Alain Sahel, describes the changes in sensorineural macular structures associated with subretinal implantation in geographic atrophy secondary to AMD. It was important to assess retinal changes with PRIMA implants because the success of retinal stimulation with micro-electrodes is largely dependent on the distance between the stimulation electrode (in the implant) and the target cells.

Spectral domain optical coherence tomography (SD-OCT) images of three patients with subretinal implantations included in the French feasibility study were analyzed to [1] measure the thickness of the retina, [2] measure the distance between the grating and the inner nuclear layer (INL, the layer of the retina made up of a number of tightly packed cells, including bipolar cells) and [3] assess any potential macular changes due to surgical trauma.

The analysis revealed that surgical placement of the photovoltaic subretinal implant led to stable retinal thickness over 36 months with no adverse structural or functional events after causing minor changes in retinal thickness that set in after three months.

“We are very pleased to announce the publication of these Peer-reviewed Data in the highly respected Journal of Neural Engineering To displaying that surgical implantation of the Prima system in patients with dry AMD leads to stable retinal thickness three months after implantation“, said Lloyd Diamond, CEO of Pixium Vision. “The small size and wireless design of the PRIMA implant enable minimally invasive surgery. Preturnexactly, the data from the French feasibility study already demonstrated that the Prima system is well tolerated. Ee given in this article now further demonstrate the stability and minimal impact of the implant once in positionnm We are in complete confidence looking forward to reading our crucial PRIMAvera study on the Prima system due late next year and planning filing for marketing authorization in Europe shortly after.”

Key points to remember
The main conclusions of the data published in the Neural Engineering Journal are:

• No significant change in the distance between the implant surface and the INL (the inner nuclear layer, the layer of the retina composed of a number of tightly packed cells, including bipolar cells) was detected
• The total thickness of the retina above the implant decreased by an average of 39 µm during the 3 months following implantation, but no significant changes were observed after that, up to 36 months of follow-up
• The observations support the hypothesis that the retina of the different areas of the implant is also supplied with nutrients and oxygen

Pixium Vision’s pivotal PRIMAvera study, which aims to demonstrate the safety and benefits of the Prima system, is ongoing in Europe, with readout expected towards the end of 2023 and regulatory submission for market approval expected shortly thereafter. . In the United States, a feasibility study is also underway.

The full peer review Neural Engineering Journal the paper is available online here.

About Vision Pixium

Vision Pixium creates a world of bionic vision for those who have lost their sight, allowing them to regain visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with surgery and a period of rehabilitation. The Prima System subretinal wireless miniature photovoltaic implant is in clinical trial for patients who have lost sight due to outer retinal degeneration, initially for dry age-related atrophic macular degeneration (dry AMD). Pixium Vision works closely with academic and research partners, including some of the most prestigious vision research institutions in the world, such as Stanford University in California, Institut de la Vision in Paris, Moorfields Eye Hospital in London, the Institute of Ocular Microsurgery (IMO) in Barcelona, ​​the University Hospital of Bonn and UPMC in Pittsburgh, PA. The company is EN ISO 13485 certified and qualified as an “Innovative Company” by Bpifrance.

Forward-Looking Statements. This press release contains certain forward-looking statements. Although the Company believes that its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. For a discussion of the risks and uncertainties that could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors section (” Risk factors”) of the Company’s 2021 report. Half-year financial report and other documents filed by the Company with the AMF, available on the AMF’s website (www.amf-france.org) or on the Company’s website.

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