Currency in EUR
Last close As at 25/03/2023
EUR0.05
▲ −0.01 (−16.67%)
Market capitalisation
EUR5m
Research: Healthcare
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 primary endpoint data at around year-end 2023. The PRIMAvera study is the final clinical trial needed before European market authorisation can be sought, and we continue to estimate that Pixium could receive potential European market approval and launch the product in H125.
Pixium Vision |
First Prima implantation in Italy |
14 September 2022 |
Share price performance Business description
Analysts
Pixium Vision is a research client of Edison Investment Research Limited |
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 primary endpoint data at around year-end 2023. The PRIMAvera study is the final clinical trial needed before European market authorisation can be sought, and we continue to estimate that Pixium could receive potential European market approval and launch the product in H125.
Clinical trial update |
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 designed to enrol 38 patients with severe GA-AMD, with the first implantation occurring in France in March 2021. The first study implantation in Italy follows the study’s approval by the Italian Ministry of Health and the opening of the first Italy-based clinical study site, the San Giovanni Addolorata Hospital in Rome.
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 visual acuity (VA) exceeding 20/100. While assisted by magnification, these measures are markedly superior to the baseline pre-implantation VA levels. We view this data as highly supportive of the potential utility and benefit of the Prima System in GA-AMD patients with severely compromised vision and for which no alternative treatment is available. The company’s recent announcement of an approved remote rehabilitation system with apps designed to improve patient engagement may further optimise the realisation of the functional benefits of the PRIMA system.
|
|
Research: Metals & Mining
Lithium Power International (LPI) has announced a successful equity placement, raising c A$25m in gross proceeds. This brings its proforma 30 June 2022 cash position to a comfortable level of A$31.5m. The funds will be used to advance LPI’s flagship Maricunga project. We have updated our model to reflect the news and LPI’s (now less dilutive) higher share price, increasing our valuation from A$1.0/share to A$1.24/share. Despite the backdrop of slowing global economic growth, lithium prices remain high reflecting tight supply/demand fundamentals and the sector’s attractive long-term growth potential.
Get access to the very latest content matched to your personal investment style.