Pixium Vision announces that it has reached the recruitment targets for its European pivotal study PRIMAvera and the implantations should be completed by the end of 2022 – 09/19/2022 at 07:00

Pixium Vision

announce

what to have achieved

I

rec objectives

r

utely

of

its European pivotal study PRIMAvera

and

them

settlements should be completed

by the end of 2022

• In line with the set target, 38 patients were recruited from clinical sites in France, Germany, the United Kingdom, the Netherlands and Italy

• A waiting list has been set up to recruit patients in the event of withdrawal or ineligibility of recruited patients

• The implantations should be completed by the end of 2022 and the results of the PRIMAvera study presented by the end of 2023

Paris, France,

19

september 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 finalizing patient recruitment for its pivotal PRIMAvera study in the dry form of age-related macular degeneration (AMD), also known as geographic atrophy.

A total of 38 patients were recruited for the PRIMAvera study (NCT04676854), a pivotal, open-label, prospective, multicentre, non-randomized, controlled trial. A waiting list has also been set up to replace any patient among the 38 recruited who is no longer eligible for implantation or who decides to leave the study before implantation. The PRIMAvera study aims to confirm the safety and clinical benefits of the Prima System. It represents the last clinical step before applying for European marketing authorization.

The study started in the fourth quarter of 2020 in France, where the first patient was recruited in December 2020. Since then, Pixium Vision has opened several new clinical sites and implanted patients in France, Germany, the United Kingdom, the -Bas and Italy. All patients will be implanted by the end of 2022, which will allow the presentation of the main endpoints of the PRIMAvera study towards the end of 2023.

“We are very pleased to have finalized recruitment for our pivotal study PRIMAvera, which has progressed tremendously since its launch at the end of 2020”,

said the

Professor Frank Holz,

investigator

principal for Germany and scientific coordinator of the PRIMAvera study.

“We look forward to moving forward with bringing this innovative technology to market for the benefit of patients with dry AMD. We look forward to finalizing the implantations by the end of the year and announcing the first results of the study towards the end of 2023.”

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. The main efficacy endpoint of the PRIMAvera study concerns the proportion of subjects benefiting from an improvement in visual acuity of at least 0.2 log MAR compared to baseline after 12 months, and the The primary safety endpoint 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.

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.

For more information :

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

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