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Pixium Vision

Pixium completes 10th implantation of Iris II study

Flash note | Pharmaceutical & healthcare | 12 Jan 2017

Pixium announced this week that it has completed the 10th and final implantation as part of its ongoing European Iris-II study. This trial began in January 2016 and will assess the Iris II epi-retinal implant in patients with retinitis pigmentosa (RP) and certain other retinal dystrophies. While the study will assess the device for at least 18 months, interim data could be available in mid-2017 and would support reimbursement applications in European countries such as the UK, France and Germany.

Pixium Vision

Forfait Innovation decision postponed

Flash note | Pharmaceutical & healthcare | 26 May 2017

Pixium announced on 24 May 2017 that the French Haute Autorité de Santé (HAS) has requested additional clinical data before agreeing to provide exceptional reimbursement under the Forfait Innovation (FI) programme for Pixium's Iris II implant system. The HAS agreed that the Iris II meets the critical FI eligibility criteria of providing a sufficiently novel and innovative treatment for a significantly unmet medical need (patients severely visually impacted by retinitis pigmentosa). Pixium now plans to provide interim six-month data from its ongoing 10-patient European Iris-II study, which should be available in Q317, to fulfil this requirement. Hence we believe a decision from HAS on potential Iris-II reimbursement under FI is not likely before late Q317 or early Q417.

Pixium Vision

H118 update reflects continued Prima progress

Update | Pharmaceutical & healthcare | 09 Aug 2018

Pixium's Prima sub-retinal wireless implant continues to advance through human feasibility trials. The EU study recently reached full enrolment and a US study is slated to start implantations in Q318. Using a risk-adjusted NPV model, we obtain a pipeline rNPV of €90.6m, vs €77.4m previously.

Pixium Vision

Focus shifts to Prima as human trials proceed

Outlook | Pharmaceutical & healthcare | 08 Mar 2018

Pixium Vision is developing Prima, a potentially breakthrough wireless sub-retinal implant that generates electrical impulses at the retinal bipolar cell level to restore a form of central visual perception in patients with advanced retinal disease. While competing retinal implants generally target rare conditions involving near-total blindness, Prima seeks to address initially a larger unmet market indication, dry age-related macular degeneration (Dry-ARMD). Prima started human feasibility studies in late 2017 and could start EU pivotal trials in H119. Using a risk-adjusted NPV model, we obtain a pipeline rNPV of EUR 77.4m, down from EUR 82.6m previously.

Pixium Vision

Successful Prima activation in first patient

Flash note | Pharmaceutical & healthcare | 30 Jan 2018

Pixium announced on 25 January 2018 the first human activation of the Prima wireless photovoltaic sub-retinal implant, following successful implantation one month ago. These events occurred as per the protocol of the five-patient European Prima feasibility study, which was approved by regulators in October 2017 to assess the device in patients who have lost light perception in their central visual field due to atrophic damage from atrophic dry age-related macular degeneration. Following Prima activation, the patient reported light perception in the central visual field, where there had been none previously, and will now proceed to visual re-training, to learn how to interpret the elicited light signals emitted by the Prima system. The successful Prima activation in this first patient is encouraging as an early suggestion of proof-of-concept that the device can interface with retinal cells to restore some visual perception. Additional implantations, along with results from the six-month safety assessment in this study, may further validate the Prima approach and potential.

Pixium Vision

Pixium cleared to start EU Prima feasibility study

Update | Pharmaceutical & healthcare | 24 Oct 2017

Pixium has received clearance from the French regulatory agency (Agence Nationale de Sécurité du Médicament et des Produits de Santé, or ANSM) to start a feasibility study of its Prima sub-retinal bionic vision system (BVS) on up to five patients with advanced Dry-ARMD. It plans to complete the first implantation before YE17, and obtain six-month study data in H218. If results are positive, Pixium expects to start an EU pivotal study in H119. We have reinstated our Prima probability of success estimate in our model to 12.5% (from 10%), leading to an increase in our pipeline rNPV to EUR 82.6m (from EUR 63.0m, previously).

Pixium Vision

Pixium seeks to address short Iris II lifespan

Update | Pharmaceutical & healthcare | 05 Oct 2017

Pixium Vision recently reported data from its 10-patient Iris II study showing that it improves visual performance, but stops operating as intended at approximately nine to 12 months post-implantation. Pixium has halted new implantations as it plans to study a potential remedy to improve longevity. We have lowered our success probability estimates and delayed our launch dates for both Iris II and Prima. Our rNPV is reduced to EUR 63.0m, from EUR 129.3m previously.

Pixium Vision

Key Iris II and Prima catalysts for H217

Update | Pharmaceutical & healthcare | 22 Aug 2017

Pixium is building up a sales channel across Europe for its Iris II device, and is working on securing reimbursement and generating initial product sales in H217. It is also planning to start first-in-human trials for the next-generation Prima implant in H217. Using a risk-adjusted NPV model, we obtain a pipeline rNPV of EUR 129.3m, compared to EUR 131.4m, previously.

Pixium Vision

Key advancements for Iris II and Prima in 2017

Outlook | Pharmaceutical & healthcare | 30 Mar 2017

Pixium Vision is developing two different retinal implants that provide vision by electrically stimulating the retina. Commercialisation efforts for Iris II are starting in Europe. Prima intends to target a larger population, and human trials could start in H117. Using a risk-adjusted NPV model, we obtain a pipeline rNPV of EUR 131.4m, up from EUR 125.5m, previously.

Pixium Vision

Raises up to EUR11m in debt to extend runway

Update | Pharmaceutical & healthcare | 19 Oct 2016

Pixium entered an agreement to issue up to €11m in bonds bearing 11.5% interest, with warrants for up to 207,817 shares. The funding should support the firm's Iris II and Prima vision restoration system programmes. Our rNPV, inclusive of estimated Q316 net cash, is €10.78 per share.

Pixium Vision

Iris II receives CE mark clearance

Update | Pharmaceutical & healthcare | 27 Jul 2016

Pixium announced on 25 July that its Iris II epi-retinal implant has received CE mark clearance from European regulatory authorities. This pivotal step helps validate the device's safety and can enable the first stage of a commercial roll-out of this device in certain European markets. Our rNPV, inclusive of net cash, is €11.62 per share (vs €10.28 previously).

Pixium Vision

Iris II and Prima continue to advance

Update | Pharmaceutical & healthcare | 15 Jul 2016

Pixium Vision implanted its first Iris II epi-retinal implant in January 2016 as part of a 10-patient European study as it awaits clearance from a CE mark application. It also reported supportive animal data on its next-generation implant, Prima, slated to start human studies by YE16. Our rNPV valuation is €10.28 per share, down from €10.50 previously.