Event in Progress:
Discover the latest content that has just been published on Research Tree
Pixium Vision announced that safeguard proceedings have been opened by the Commercial Court of Paris. Despite the company’s best efforts in seeking financing options to extend its funding runway, it has determined that it may not be able to satisfy its financial obligations after the end of November 2023 without the protection of such proceedings. Given its liquidity risk and the absence of new financing to date, Pixium requested that the Commercial Court of Paris open safeguard proceedings. As
Companies: Pixium Vision
Edison
Pixium Vision recently announced that it has received a €3m bridge financing loan from shareholders Sofinnova (€1m) and Bpifrance (€2m), which extend its cash runway through to the end of November. The loan will bear interest at 12% pa and mature on 31 July 2023. The loan is a positive step and signal of confidence from these two institutional investors as Pixium works towards securing broader additional financing to bring it past the conclusion of the PRIMAvera European pivotal study, for which
Having completed the required 38 implantations in late 2022, Pixium Vision’s key upcoming clinical milestone is the primary efficacy data, expected in or around year-end 2023, from the PRIMAvera European pivotal study assessing the safety and clinical benefits of the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The company’s FY22 results showed a milder operating loss than expected, coming in at €11.9m, below our €12.5m estimate. Pix
The US Food and Drug Administration (FDA) has granted Breakthrough Device designation (BDD) to Pixium’s wireless Prima bionic vision system (BVS), which is currently being assessed in the European PRIMAvera pivotal study in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). This achievement suggests that the FDA recognises GA-AMD is an irreversibly debilitating human disease and that Prima BVS has the potential to provide an effective treatment in this area of unm
Pixium has terminated its convertible note financing arrangement with the European Select Growth Opportunities Fund (ESGO) without any penalties. The termination is not surprising, given the arrangement required a minimum share price of €0.25 for Pixium to be permitted to issue any additional convertible notes beyond the initial 550 (representing €5.5m; each note had a nominal value of €10,000) that formed part of the first (and only) tranche issued. Pixium’s share price had remained below this
Pixium has announced the publication of data in three peer reviewed journals highlighting that its second-generation (2G) Prima sub-retinal implant chip has the potential to restore vision at an up to five times higher spatial resolution than the current-generation (1G) implant chip. While the 1G implant is being advanced for patients with severe vision loss due to dry age-related macular degeneration (dry AMD), we believe the 2G Prima, if successful, can significantly expand the addressable tar
Meeting its prior guidance, Pixium Vision has now completed all of the implantations required as part of the PRIMAvera pivotal trial assessing the safety and clinical benefits of the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). In total, 38 patients have been implanted with the Prima sub-retinal photovoltaic device and Pixium expects to report primary endpoint data around the end of 2023, filing for European approval in H124. We cont
Meeting its prior guidance, Pixium Vision announced that it has now reached its enrolment target of 38 patients for the PRIMAvera pivotal trial assessing the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The company has also established a waiting list for additional patients in the event that any of the currently enrolled 38 patients become ineligible for implantation or drop out of the study. Pixium expects to complete all implantati
Pixium Vision announced the successful first implantation of a patient in Italy as part of the PRIMAvera pivotal trial assessing the wireless Prima System in patients with geographic atrophy due to age-related macular degeneration (GA-AMD). The expansion of PRIMAvera to Italy follows implantations occurring at sites in France, Germany, the UK and the Netherlands. The company reiterated its guidance that it expects to complete PRIMAvera study patient enrolment by year-end FY22, and to report prim
Research Tree provides access to ongoing research coverage, media content and regulatory news on Pixium Vision. We currently have 10 research reports from 2 professional analysts.
Share: