Project description DEENESFRITPL Novel treatment targets the origin of atrial fibrillation Atrial fibrillation is a type of heart arrhythmia when rapid heart rate caused by chaotic electrical impulses in the atria result in rapid, uncoordinated contractions. This is a life-threatening condition with serious complications, such as stroke, and high worldwide prevalence. The most effective currently available treatment is cardiac ablation that specifically destroys heart tissue that triggers abnormal rhythm. However, this treatment requires highly trained personnel and carries significant risk of complications. AtriAN Medical has developed a novel treatment to target specifically the origin of the signal that causes atrial fibrillation and prevents the arrhythmia. This treatment promises high success rates and reduced risk of complications. The current EU-funded Neuron-AFib project will finalise testing and validation of the technology in order to meet regulatory requirements, followed by a safety and treatment efficacy clinical trial with broad patient enrolment. Show the project objective Hide the project objective Objective 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. Fields of science medical and health sciencesclinical medicinecardiologycardiovascular diseasescardiac arrhythmia Keywords Atrial Fibrillation Ablation Arrhythmia Programme(s) H2020-EU.2.3. - INDUSTRIAL LEADERSHIP - Innovation In SMEs Main Programme H2020-EU.3. - PRIORITY 'Societal challenges H2020-EU.2.1. - INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies Topic(s) EIC-SMEInst-2018-2020 - SME instrument Call for proposal H2020-EIC-SMEInst-2018-2020 See other projects for this call Sub call H2020-SMEInst-2018-2020-2 Funding Scheme SME - SME instrument Coordinator ATRIAN MEDICAL LIMITED Net EU contribution € 2 348 941,00 Address UNIT 204 NUIG BUSINESS INNOVATION CENTRE UPPER NEWCASTLE H91W60E GALWAY Ireland See on map SME The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed. Yes Region Ireland Northern and Western West Activity type Private for-profit entities (excluding Higher or Secondary Education Establishments) Links Contact the organisation Opens in new window Participation in EU R&I programmes Opens in new window HORIZON collaboration network Opens in new window Total cost € 3 358 205,00
