Pixium Vision SA

Pixium Vision SA is a company that specializes in sensorial neuromodulation. Co. is also collaborating with scientific groups and clinicians at research institutes and clinical centers around the world, including Stanford University (USA). Co. is developing and aims to commercialize Bionic Vision Systems (BVS) – namely active implantable medical devices to treat blindness caused by degeneration of photoreceptor cells in the retina.
  • TickerALPIX
  • ISINFR0011950641
  • ExchangeEuronext Paris
  • SectorHealth Care Equipment & Services
  • CountryFrance

Pixium Vision - ANSM approval to start PRIMAvera pivotal study

Pixium Vision announced on 20 November that it has received approval from the French regulatory health authority, ANSM, to start its PRIMAvera European pivotal study of its Prima Bionic Vision System (BVS) in patients with dry age-related macular degeneration with geographic atrophy (GA-AMD), a largely unmet market indication. This is an important milestone for Pixium as we believe the PRIMAvera European registration study may provide top-line 12-month data in H222, supporting our estimate of potential CE mark and European launch in H223.

Pixium Vision - ANSM approval to start PRIMAvera pivotal study

Pixium Vision announced on 20 November that it has received approval from the French regulatory health authority, ANSM, to start its PRIMAvera European pivotal study of its Prima Bionic Vision System (BVS) in patients with dry age-related macular degeneration with geographic atrophy (GA-AMD), a largely unmet market indication. This is an important milestone for Pixium as we believe the PRIMAvera European registration study may provide top-line 12-month data in H222, supporting our estimate of potential CE mark and European launch in H223.

Pixium Vision - Q3 results in line, awaiting pivotal study approval

Pixium Vision provided an update on its 9M20 cash flow results, which are broadly in line with H120 trends. The company reported a 9M20 operating cash outflow of €4.2m and a gross cash position of €13.3m at the end of the quarter. We believe Pixium’s funds on hand should be sufficient to support its ongoing operations into Q421, thus including at least several months of initial ramp-up of the upcoming PRIMAvera pivotal study on the Prima bionic vision system (BVS).

Pixium Vision - H120 results broadly in line

Pixium Vision recently reported H120 results that were broadly in line with our forecasts. The operating loss of €3.27m was mildly above our €2.77m forecast, with the difference primarily due to R&D costs (€2.86m) coming in €0.26m higher than anticipated. Free cash outflow was €2.81m compared to our estimate of €2.83m. Gross cash at 30 June was €5.0m and given that gross debt (excluding €1.2m in lease liabilities) was €5.86m, we calculate net debt of €0.86m.

Pixium Vision - €7.3m capital increase completed

Pixium on 6 July reported that it has raised €7.3m through its shareholder rights offering initiative. The subscription rate was >94% and 14.68m new shares have been issued on 8 July at a subscription price of €0.50/share, resulting in €7.3m in gross proceeds. This financing round should enable Pixium to start the PRIMAvera pivotal study on Prima, which we expect will begin recruitment in H121. We estimate Pixium’s cash on hand should now extend its cash runway into Q421. Our enterprise value of €105.9m is unchanged but our equity value per share (inclusive of net cash) decreases to ...

Pixium Vision - Restoring eyesight in advanced Dry-AMD

Pixium Vision is developing Prima 2, a potentially breakthrough wireless bionic vision system (BVS) that generates electrical impulses at the retinal bipolar cell level to restore a form of central visual perception. It is on track to file to start a pivotal study in H220 for the treatment of advanced dry age-related macular degeneration (dry-AMD) involving geographic atrophy (GA). We obtain an enterprise value valuation of €105.9m, vs €98.0m previously. A rights offering is underway, expiring in July, which could raise €7.8m and increase the number of shares outstanding by 57.7%.

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