(BFM Bourse) – The US health authority has just awarded Breakthrough Device status to Prima, the bionic vision system for the visually impaired developed by Pixium Vision. The stock soared on the Paris Stock Exchange.
A fanfare weekend for Pixium Vision. The title of the company specializing in innovative bionic vision systems allowing patients who have lost their sight to live more independently, soared by nearly 400% to 0.1500 euro, faced with a market for the moment reassured by the slowdown in inflation in the euro zone.
The reason for this sudden surge in the course of the penny stock? The company announced on Friday morning that it had obtained the status Breakthrough Device from the Food and Drug Administration, the health authority in the United States, for the Prima system in the treatment of age-related macular degeneration (AMD) in its dry atrophic form.
“Revolutionary Technology”
The statute Breakthrough Device aims to provide patients and healthcare providers with rapid access to new medical devices that enable more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions, by accelerating their development, evaluation and investigation .
“To obtain it, the device must have breakthrough technology, there must be no FDA-approved or cleared alternatives to the device, it must have significant advantages over existing approved or cleared alternatives, or , its application must serve the best interests of patients”, recalls Pixium Vision.
Reimbursement paths potentially facilitated in the United States
And this is the case of the world’s unique bionic vision system designed by the firm founded by Bernard Gilly and now managed by Lloyd Diamond (a veteran of the sector who participated in the marketing of various disruptive “orthobiology” technologies ). The Prima system brings hope for people suffering from severe visual impairment linked to AMD. Age-related macular degeneration is a degenerative disease affecting the eye, the leading cause of visual impairment and blindness in people over 65 in developed countries.
The system developed by Pixium Vision is a photovoltaic device 2 millimeters thick which should restore some visual perception to visually impaired patients suffering from the dry atrophic form of AMD. Concretely, this device converts an infrared signal received from an external visual interface fitted with a micro-camera into an electrical signal transmitted to the brain via the optic nerve. It thus allows patients suffering from age-related macular degeneration (AMD) in its dry atrophic form, to partially recover their sight.
The company recalls having finalized in December 2022 the implementation of its European pivotal study PRIMAvera and confirmed the announcement of the main study evaluation criteria by the end of 2023 as well as the regulatory submission in Europe in the first half of 2024.
“This status [Breakthrough Device] allows us not only to accelerate the development of the Prima System, but also to work closely with the FDA to improve the Prima System for regulatory submission in the United States. In addition, after marketing authorization, obtaining Breakthrough Device status facilitates access to reimbursement channels for outpatients and hospitalized patients,” said Lloyd Diamond, CEO of Pixium Vision.
Sabrina Sadgui – ©2023 BFM Bourse
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