Descrizione del progetto
Un nuovo trattamento mira all’origine della fibrillazione atriale
La fibrillazione atriale è un tipo di aritmia cardiaca in cui la frequenza cardiaca rapida provocata da impulsi elettrici caotici negli atri provoca contrazioni rapide e non coordinate. Si tratta di una condizione pericolosa per la vita con gravi complicazioni, quali l’ictus, e un’alta prevalenza in tutto il mondo. Il trattamento attualmente più efficace disponibile è l’ablazione cardiaca che distrugge specificamente il tessuto cardiaco che innesca un ritmo anormale. Tuttavia, questo trattamento richiede personale altamente qualificato e comporta un rischio significativo di complicanze. AtriAN Medical ha sviluppato un nuovo trattamento per colpire specificamente l’origine del segnale che provoca la fibrillazione atriale e previene l’aritmia. Questo trattamento promette alti tassi di successo e riduzione del rischio di complicanze. L’attuale progetto Neuron-AFib, finanziato dall’UE, finalizzerà i test e la convalida della tecnologia al fine di soddisfare i requisiti normativi, per poi procedere alla sperimentazione clinica sulla sicurezza e l’efficacia del trattamento con ampio arruolamento di pazienti.
Obiettivo
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.
Campo scientifico
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Programma(i)
Argomento(i)
Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEInst-2018-2020-2
Meccanismo di finanziamento
SME - SME instrumentCoordinatore
H91W60E GALWAY
Irlanda
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.