Pixium Vision announces FDA Breakthrough Device Designation for the Prima System in Dry AMD

Pixium Vision announces FDA Breakthrough Device Designation for the Prima System in Dry AMD

• Pixium Vision to receive interactive communication with FDA through premarket review phase of Prima System and potential prioritized regulatory review
• Breakthrough Device Designation aims to expedite development of medical devices that can treat or diagnose life-threatening or debilitating conditions
• PRIMAvera European pivotal trial in dry AMD fully recruited and on track to report primary endpoints around the end of 2023
• Streamlined reimbursement options available upon approval in the United-States

Paris, France, March 31, 2023 – 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 independent lives, announces today the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company's Prima System, a photovoltaic substitute of photoreceptors providing simultaneous use of the central prosthetic and peripheral natural vision implanted in human patients with atrophic dry age-related macular degeneration (AMD) to partially restore their vision.

The Breakthrough Device Designation aims to supply patients and healthcare providers with timely access to new medical devices that offer more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions by speeding up their development, assessment and review. To receive the designation, a device must also have either breakthrough technology, or no approved or cleared alternatives, or significant advantages over existing approved or cleared alternatives, or its availability must be in the best interest of patients.

Under the program, Pixium Vision will have the opportunity to interact with the FDA's experts during the premarket review phase of the Prima System to identify areas of agreement in a timely way and could also receive prioritized review of the regulatory submission.

"To receive this Breakthrough Device Designation and have the FDA recognize the therapeutic potential of our Prima System is a significant achievement for Pixium Vision, especially as only a small proportion of devices awarded the designation are intended to treat ophthalmologic conditions¹," said Lloyd Diamond, Chief Executive Officer of Pixium Vision. "Our Prima System is making great progress in the clinic with a read-out on the primary endpoints due toward the end of this year. This designation not only helps us to expedite the development of the Prima System but also affords us the opportunity of working closely with the FDA in refining the Prima System for its US regulatory submission. In addition, after receiving market authorization, there are outpatient and inpatient reimbursement pathways that are more readily accessible as a result of receiving Breakthrough Device Designation."