Pixium Vision announces business update and key upcoming milestones to deliver on its business plan

Pixium Vision announces business update and key upcoming milestones to deliver on its business plan

• 1^st patient successful implant activation in PRIMAvera pivotal EU study
• On track to report PRIMAvera data in early 2023 and submit CE mark in H1 2023
• Aims to capitalize on enhanced interest from US investors
• Options includes potential Nasdaq listing; US Investment bank hired

Paris, France, June 2, 2021 – 07.00 CET– Pixium Vision SA (Euronext Growth Paris - FR0011950641), a bioelectronics company that develops innovative bionic vision systems to enable patients who have lost their sight to live more independent lives, provides a full business update and announces an active exploration of several options to ensure the development of the Prima System, including a potential listing on the NASDAQ stock exchange in the US, while retaining its existing primary listing on Euronext Growth Paris.

Lloyd Diamond, CEO of Pixium Vision, commented "Pixium Vision has remained laser focused on its objectives and has continued to deliver on its promises, despite the challenging environment for the Company and the overall industry through 2020 and the early months of 2021. The revolutionary Prima System for bionic vision continues to advance through clinical development with the PRIMAvera pivotal study having recently activated its first implanted patient. Our fruitful discussions with US investors over the last 6 months have indicated strong interest in Pixium Vision and its technology. To capitalize on these discussions and gain an easier access to US investors, Pixium Vision has hired a leading US investment bank to advise on possible options, including the best route to a possible IPO on US NASDAQ. Accessing this large investment pool will provide a tremendous opportunity to Pixium Vision to accelerate clinical development and prepare for the commercial launch of Prima System in late 2023."

PRIMAvera European pivotal trial – On track for CE Mark submission in H1 2023

The pivotal PRIMAvera clinical trial is under way with the first patient enrolled and implanted. The first implanted patient was recently activated and the training phase has been initiated. Patients continue to be screened and the study remains on track to report data early 2023 for a CE Mark submission in Europe in H1 2023, leading to a potential European approval in late 2023.

Prima System in the US – Feasibility study ongoing - data expected in H2 2022

In the US, the early feasibility study is ongoing with data expected in H2 2022. While discussions have slowed due to the COVID-19 pandemic, Pixium Vision is hopeful of gaining further visibility on this process towards the end of 2021. Should the data generated by PRIMAvera be accepted by the FDA as sufficient to file for regulatory approval, an FDA submission could take place sooner than expected.

US NASDAQ listing considered – US Investment bank hired

Accessing the US market is a key priority and could bring significant benefits to Pixium Vision, by broadening physical and financial presence in this key market. There has been increased interest from US investors in Pixium Vision and its technology in the last six months. In order to facilitate this interest, Pixium Vision’s Board of Directors has decided to analyze the various options, including a potential listing on the US NASDAQ stock exchange, and has hired a leading US Investment bank to advise on this process.

Following Second Sight’s decision to unilaterally terminate the planned business combination, Pixium Vision has attempted to reach common agreement outside court but Second Sight has failed to respond. To defend the interest of its shareholders, Pixium Vision filed a legal action in France against Second Sight. As with any ongoing legal proceeding, Pixium Vision will update the market whenever legally required.

About Pixium Vision

Pixium Vision is creating a world of bionic vision for those who have lost their sight, enabling them to regain visual perception and greater autonomy. Pixium Vision’s bionic vision systems are associated with a surgical intervention and a rehabilitation period. Prima System sub-retinal miniature photovoltaic wireless implant is in clinical testing for patients who have lost their sight due to outer retinal degeneration, initially for atrophic dry age-related macular degeneration (dry AMD). Pixium Vision collaborates 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, Institute of Ocular Microsurgery (IMO) in Barcelona, University hospital in Bonn, and UPMC in Pittsburgh, PA. The company is EN ISO 13485 certified and qualifies as "Entreprise Innovante” by Bpifrance.

For more information:  http://www.pixium-vision.com/fr

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Contacts

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