Description du projet
Un nouveau traitement cible l’origine de la fibrillation auriculaire
La fibrillation auriculaire est un type d’arythmie cardiaque qui survient lorsqu’une fréquence cardiaque élevée causée par des impulsions électriques désordonnées dans les oreillettes entraîne des contractions rapides et non coordonnées. Il s’agit d’un état dangereux ayant de graves complications, comme un accident vasculaire cérébral, et dont la prévalence dans le monde est élevée. Le traitement le plus efficace actuellement disponible est une ablation cardiaque qui détruit précisément le tissu cardiaque qui déclenche le rythme anormal. Toutefois, ce traitement nécessite du personnel hautement formé et comporte un risque considérable de complications. AtriAN Medical a mis au point un nouveau traitement pour cibler spécifiquement l’origine du signal qui cause la fibrillation auriculaire et prévenir l’arythmie. Ce traitement promet des taux élevés de réussite et diminue le risque de complications. Le projet Neuron-AFib actuel, financé par l’UE, achèvera les essais et la validation de cette technologie afin de répondre aux exigences réglementaires, avant de réaliser un essai clinique de sécurité et d’efficacité du traitement auprès de nombreux patients.
Objectif
Atrial Fibrillation (AFib) is a debilitating and life-threatening condition with a high and increasing prevalence worldwide. However current treatments have low success rates and have significant risks and complications. Moreover, the most widely used treatment – cardiac ablation - still has limited adoption with the majority of patients hesitant to be treated knowing the potential for poor outcomes and complications. In addition, current treatments have even lower success rates and higher complications in women.
AtriAN Medical is bringing a revolutionary treatment to market that is the first to specifically target the origin of the signal that causes AFib, thus eliminating the arrhythmia and disease progression. In addition to increased success rates, the AtriAN technology will reduce the risk of complications and the procedure will be done in a fraction of the time needed for current treatments; approximately 2 hours compared to 6-8 hours. The treatment will work equally well in women and men.
AtriAN conservatively estimates that it will have turnovers of €85M per annum within one year of regulatory approvals. AtriAN has a senior management team in place with significant medical device industry experience in technology development, manufacturing and scale up from start-up to multinational size.
AtriAN needs to perform a clinical trial in order to gain CE-marking to allow sales in Europe. AtriAN is planning for CE approvals by 2022 and FDA approval by 2026.
The proposed Neuron AFib project will first finalise the device testing and validation needed in order to meet regulatory requirements and will then perform the clinical trial, with equal female and male enrolment, in order to demonstrate safety and efficacy of the treatment. AtriAN has already raised €3.8 million of funds needed to close out research activities but needs another €2.4 million to execute on the testing, validation and clinical trial needed to reach CE approval and commercial launch.
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SME - SME instrumentCoordinateur
H91W60E GALWAY
Irlande
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.