Pixium Vision announces the implantation of the first patient in Italy in Prima System’s pivotal PRIMAvera European study
- First patient treated at PRIMAvera clinical site in Rome, Italy
- Tracks successful implantations at clinical sites in France, Germany, UK and the Netherlands
- PRIMAvera should be read out at the end of 2023
Paris, France, September 13, 2022 – 07:00 CET – Pixium Vision SA (Euronext Growth Paris – FR0011950641; Mnemonic: ALPIX), a bioelectronics company developing innovative bionic vision systems to enable patients with vision loss to live more independently, today announces the successful first-time implantation of a patient in Italy in the pivotal PRIMAvera study in atrophic dry age-related macular degeneration (dry AMD).
This follows the approval of the PRIMAvera study by the Italian Ministry of Health and the opening of the first clinical site in Italy at the Complesso Ospedaliero San Giovanni Addolorata. The PRIMAvera study aims to confirm the safety and benefits of the Prima system and is the final clinical step prior to filing for marketing approval in Europe. The study was initiated in France in the fourth quarter of 2020. Since then, Pixium Vision has established additional clinical sites and implanted patients in Germany, the UK and the Netherlands.
“We are very happy to have successfully implanted the first patient in Italy with the Prima system as part of the expansion PRIMAvera pivotal study”, said prof. Andrea Cusumano, With-Investigator of the PRIMAvera study for Italy. “We followed the development of the Prima system since its inception and we’ve seen the significant promise it shows for those suffering from dry AMDa disease for which we strive to offer patients and their families an acceptable solution and hope. Primate small size and wireless design means implantation is a simple procedure that can be completed with minimal surgical intervention. we will now proceed implantations aand we are happy to Addeng our…
