Pixium Vision announces the first implantation of the Prima System in a patient in Italy as part of the PRIMAvera European pivotal study – 09/13/2022 at 07:00

Pixium Vision announces the first implantation of the Prima System in a patient in Italy as part of the European PRIMAvera pivotal study

• The clinical site for the PRIMAvera study in Rome (Italy) treated its first patient

• This establishment is in line with the success of previous establishments in France, Germany, the United Kingdom and the Netherlands.

• PRIMAvera results expected to be announced as expected in late 2023

Paris, France, September 13, 202

2

– 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 more independently, today announces the success of the first implantation in a patient in Italy as part of the PRIMAvera pivotal study on the dry form of age-related macular degeneration (AMD).

This follows the approval of the PRIMAvera study by the Italian Ministry of Public Health and the opening of the first clinical site in Italy in

Complesso

Ospedaliero

San Giovanni

Addolorata

(San Giovanni Addolorata Hospital Center). The PRIMAvera study, which aims to confirm the safety and benefits of the Prima System, represents the last clinical step before applying for marketing authorization in Europe. The study was launched in France in the fourth quarter of 2020. Since then, Pixium Vision has opened several new clinical sites and placed implants in patients in Germany, the United Kingdom and the Netherlands.

”

We are very satisfied with the success of this implantation in a first patient in Italy, as part of the pivotal PRIMAvera study.

in the open

leave

. »,

entrusted the

Teacher. andrea

Cusumano

,

co

-investigator of the PRIMAvera study for Italy.

“From the start, we followed the development

nt of the Prima System and have witnessed its promising results for patients suffering from dry AMD, a disease for which it is difficult to offer an acceptable solution, a source of hope, for patients and their families. Thanks to its small size and wireless design, PRIMA offers simple implantation with minimal surgery. We will now proceed with further implantations and we look forward to joining our efforts in the clinical evaluation of this innovative technology. »

The design of the PRIMAvera study is based on the positive data generated by a French feasibility study, showing the ability of the Prima System to improve the visual acuity of patients with dry AMD.

A total of 38 patients will participate in the PRIMAvera study, an open-label, prospective, multicenter, non-randomized, controlled pivotal trial. The primary efficacy endpoint is the proportion of subjects experiencing an improvement in visual acuity of at least 0.2 logMAR from baseline to the end of Month 12, and the primary endpoint of Safety rating is the number and severity of device- and procedure-related adverse events after 12 months of follow-up. The study will include three years of follow-up, with assessment of the main endpoints 12 months after implantation.

The implantations were carried out in five sites in France, four in Germany, as well as at Moorfields Eye Hospital in the United Kingdom, at Rotterdam Eye Hospital in the Netherlands and finally at Complesso Ospedaliero San Giovanni Addolorata in Italy. Pixium Vision expects recruitment to be complete by the end of 2022, allowing to announce the results of the PRIMAvera study towards the end of 2023.

About Pixium Vision

Pixium Vision

creates a world of bionic vision to allow those who have lost their sight to recover their visual perception and gain autonomy. Pixium Vision’s bionic vision systems are associated with surgery and a period of rehabilitation. The Prima System’s wireless photovoltaic subretinal micro-implant is in clinical testing in patients who initially lost sight due to retinal degeneration 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 about 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. of the Company’s 2021 half-year financial report and other documents that the Company files with the AMF, available on the AMF’s website (www.amf-france.org) or on the Company’s website.

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