Last close As at 05/08/2026
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Research: Healthcare
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 implantation procedures of the Prima sub-retinal photovoltaic device by year-end FY22, and to report primary endpoint data at around year-end 2023.
Pixium Vision |
PRIMAvera reaches full enrolment |
20 September 2022 |
Share price performance
Business description
Analysts
Pixium Vision is a research client of Edison Investment Research Limited |
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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 implantation procedures of the Prima sub-retinal photovoltaic device by year-end FY22, and to report primary endpoint data at around year-end 2023.
Clinical trial |
Healthcare equipment |
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
2.1 |
(8.7) |
(0.26) |
0.0 |
N/A |
N/A |
12/21 |
2.7 |
(10.9) |
(0.23) |
0.0 |
N/A |
N/A |
12/22e |
1.8 |
(12.3) |
(0.22) |
0.0 |
N/A |
N/A |
12/23e |
0.8 |
(18.2) |
(0.29) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
The PRIMAvera study began in Q420, and is the final clinical trial needed before Pixium can seek European market authorisation. Patients have been enrolled in clinical sites in France, Germany, the UK, the Netherlands and, most recently, Italy.
The primary efficacy endpoint of the study is the proportion of subjects with an improvement of visual acuity (VA) of logMAR 0.2 or greater from baseline 12 months following implantation. The PRIMAvera study will include three years of follow-up, but we expect the company can submit a CE mark regulatory approval application in Europe following the 12-month primary efficacy data. We continue to estimate that Pixium could receive potential European market approval and launch the product in H125.
As a reminder, 18–24 month interim data from the five-patient, 36-month European feasibility study (PRIMA-FS) confirmed the safety and stability of the Prima System over the PRIMA-FS study period. Study authors noted that all patients with subretinal implantation and electronic magnification could demonstrate VA exceeding 20/100. While assisted by magnification, these measures are markedly superior to the baseline pre-implantation VA levels. We view this PRIMA-FS data as highly supportive of the potential utility and benefit of the Prima System in GA-AMD patients with severely compromised vision for which no alternative treatment is available.
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Research: Industrials
The memorandum of understanding (MOU) signed with energy heavyweight Total Eren gives real credibility to Provaris Energy’s compressed green hydrogen transportation solution and may also lead to funding options that make it a reality. The timing of the MOU is perfect as it comes at a time when the EU is introducing initiatives and investment to accelerate the introduction of green hydrogen into the energy mix, to improve energy reliability and push its zero-carbon agenda. Approval for construction of vessels could be the next key announcement that makes Provaris the genuine first mover in the space.