Pixium Vision announces FDA approval of clinical trial expansion of Prima System US feasibility study to Stanford Medicine

Pixium Vision announces FDA approval of clinical trial expansion of Prima System US feasibility study to Stanford Medicine

• FDA approves new additional study location at Stanford Medicine
  
  

Paris, France, January 19, 2022 – 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, announces today the approval by US FDA of the expansion of the Prima System* US feasibility study to include Stanford Medicine as a clinical site.

This third location for the study at the Byers Eye Institute at Stanford Medicine joins the original two locations at the UPMC Eye Center in Pittsburgh and the Bascom Palmer Eye Institute in Miami.

The US feasibility study aims to evaluate the safety and performance of the Prima System in patients with dry AMD and will recruit 5 patients. The primary endpoint is Near Visual Acuity assessment measured at 12 months. Data readout is expected in 2023. A separate feasibility study conducted in France showed improved visual acuity in patients with dry AMD with use of the Prima System. A pivotal study of the Prima System is underway in several European countries.

Pixium licensed technology from Stanford University.

"We are very pleased to be expanding the number of sites of our Prima System US feasibility study," said Lloyd Diamond, Chief Executive Officer of Pixium Vision. "We know that the medical team is very familiar with the design of the implants and we look forward to observing the results of their procedures first hand."

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 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.

Forward-Looking Statements. This press release contains certain forward-looking statements. Although the Company believes 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 a discussion of risks and uncertainties which 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 (“Facteurs de Risques”) section of the Company’s 2021 Half-Year Financial Report and other documents the Company files with the AMF, which is available on the AMF website (www.amf- france.org) or on the Company’s website.

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

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* CAUTION - Investigational device. Limited by United States law to investigational use.