Pixium Vision announces the publication in the Journal of Neural Engineering of peer-reviewed clinical data on the efficacy of the Prima System in patients with dry AMD – 10/11/2022 at 07:00

Pixium Vision announces the publication in the

Journal of Neural Engineering

of peer-reviewed clinical data on the efficacy of the Prima System in patients with dry AMD

• Stability of distance between implant and target cells in long-term follow-up

• No significant change in the thickness of the retina observed following a first phase of slight retinal thinning

Paris, France,

11

october 202

2

– 07:00 CET – Pixium Vision SA (Euronext Growth Paris – FR0011950641; Mnemo: ALPIX), a bioelectronics company developing innovative bionic vision systems enabling patients who have lost their sight to live more independently, today announces the publication of an article in the scientific journal

Journal of Neural Engineering

presenting new data on its Prima System, a photovoltaic substitute for photoreceptors that allows simultaneous use of prosthetic central vision and natural peripheral vision. Implanted in patients suffering from dry age-related macular degeneration (AMD) in its dry atrophic form, it allows them to partially recover their sight.

The peer-reviewed article published in the

Journal of Neural Engineering

entitled ”

Long-term Observations of Macular Thickness after Subretinal Implantation of a Photovoltaic Electronic Prosthesis in Patients with Dry Age-related Macular Degeneration

(or “Long-term observations of macular thickness after subretinal implantation of a photovoltaic electronic prosthesis in patients with dry age-related macular degeneration”), and written by Mahiul MK Muqit, Yannick Le Mer , Frank Holz and José-Alain Sahel, describes the changes in neurosensory macular structures associated with subretinal implantation in geographic atrophy produced by AMD. It was important to evaluate the retinal changes after implantation of the PRIMA system because the success of retinal stimulation by micro-electrodes depends, to a large extent, on the distance between the stimulation electrode (placed on the implant) and the target cells.

The images obtained via spectral domain optical coherence tomography (SD-OCT) of three patients who had been implanted with a subretinal device and participated in the French feasibility study were analyzed. These analyzes had three objectives: [1] measure the thickness of the retina, [2] measure the distance between the group of electrodes and the inner nuclear layer (or “INL” for “

Inner Nuclear Layer

“: this is the layer of the retina composed of a number of tightly packed cells, including bipolar cells) and [3] assess any potential macular changes related to operative trauma.

Results revealed that surgical implantation of the photovoltaic subretinal device led to stable retinal thickness over 36 months, with no adverse events of a structural or functional nature, after causing minor changes in retinal thickness that subsided after three months.

”

We are very pleased to announce the publication of this peer-reviewed data in the renowned

Journal of Neural Engineering

demonstrating that surgical implantation of the Prima System in patients with dry AMD leads to stable retinal thickness three months after implantation

“, said

Lloyd Diamond, Managing Director of Pixium Vision

. ”

Thanks to its small size and wireless design, the PRIMA implant

guarantees minimally invasive surgery. Previous data from the French feasibility study had already demonstrated that the Prima system was well tolerated. The data in this paper provide further evidence for the stability

and minimal impact

of the implant once in place. We are confidently awaiting the results of our pivotal PRIMAvera study on the Prima system, scheduled for the end of next year, and the European marketing authorization application shortly thereafter. »

Main findings



The main conclusions of the results published in the

Journal of Neural Engineering

are the following :

• No significant change in the distance between the implant surface and the INL was recorded.

• 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 thereafter, up to 36 months of follow-up .

• These observations confirm the hypothesis that the different areas of the retina covering the implant are equally supplied with nutrients and oxygen.

Pixium Vision’s pivotal PRIMAvera study to demonstrate the safety and benefits of the Prima System continues in Europe. The results are expected by the end of 2023, while the marketing authorization application will be submitted shortly thereafter. In the United States, a feasibility study is also underway.

The full peer-reviewed article published in the

Journal of Neural Engineering

is available online here.

About Pixium Vision

Pixium Vision

creates a world of bionic vision to allow those who have lost their sight to regain visual perception and gain autonomy. Pixium Vision’s bionic vision systems are associated with surgery and a period of rehabilitation. The Prima System wireless photovoltaic subretinal micro-implant is in clinical testing in patients who have lost their sight due to retinal degeneration, initially due to the dry form of age-related macular degeneration (dry AMD ). Pixium Vision works closely with academic partners and 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 in Bonn and the UPMC in Pittsburgh (Pennsylvania, USA). The Company is EN ISO 13485 certified and has received the “Innovative Company” qualification from Bpifrance.

Forward-looking statements. This press release contains 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 more information on the risks and uncertainties that could cause the results, financial situation, performance or achievements actually obtained by the Company to differ from those contained in the forward-looking statements, please refer to the section “Factors risks” of the Company’s 2021 half-year financial report and the other documents that the Company files with the AMF, available on the AMF’s website (www.amf-france.org) or on the website of the Company.

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http://www.pixium-vision.com/en

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