Periodic Reporting for period 2 - Neuron-AFib (Commercialising cardiac autonomic modulation to treat Atrial Fibrillation)
Période du rapport: 2021-02-01 au 2022-07-31
Atrial Fibrillation (AFib) is a debilitating and life-threatening condition with a high and increasing prevalence worldwide. The irregular heart-beat of AF causes the patient to have palpitations, weakness, fatigue and dizziness. In addition, patients with AFib are five times more likely to have a stroke due to the formation of clots. 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. Between 20-40% of patients that receive a cardiac ablation will need a repeat treatment after 2-3 years.
The economic burden of atrial fibrillation is substantial – it is estimated that approximately 2.6% of all healthcare expenditure in Europe is spent on AFib. The annual cost of dealing with stoke that originates from AFib is estimated to be €45 billion a year in the EU.
AtriAN Medical is bringing a revolutionary treatment to market that is the first to specifically target the autonomic origin of the signal that causes AFib, thus eliminating the arrhythmia early and preventing 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.
AtriAN's technology uses specialized catheters delivering short pulses of low energy electrical fields to discrete sites of autonomic hyperactive nerves located on the outside surface of the heart. This pulsed electric field selectively ablates these autonomic nerve structures, providing a long-term resolution to AFib. The treatment may be used as a stand-alone approach in certain patients or can be used in conjunction with conventional treatments to improve outcomes.
The overall objective of the Neuron-AFib project was to complete a first-in-human (FIH) trial to evaluate this technology; to provide data on safety and feasibility data. This trial was successfully completed with safety and feasibility data obtained for 24 patients as well as promising acute measures of longer term efficacy. This now enables AtriAN to progress to further trials in order to get regulatory approvals for sale of the device in Europe and the US. In parallel with the FIH trial development on a next generation of the device, for minimally invasive access, was also performed.
The economic burden of atrial fibrillation is substantial – it is estimated that approximately 2.6% of all healthcare expenditure in Europe is spent on AFib. The annual cost of dealing with stoke that originates from AFib is estimated to be €45 billion a year in the EU.
AtriAN Medical is bringing a revolutionary treatment to market that is the first to specifically target the autonomic origin of the signal that causes AFib, thus eliminating the arrhythmia early and preventing 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.
AtriAN's technology uses specialized catheters delivering short pulses of low energy electrical fields to discrete sites of autonomic hyperactive nerves located on the outside surface of the heart. This pulsed electric field selectively ablates these autonomic nerve structures, providing a long-term resolution to AFib. The treatment may be used as a stand-alone approach in certain patients or can be used in conjunction with conventional treatments to improve outcomes.
The overall objective of the Neuron-AFib project was to complete a first-in-human (FIH) trial to evaluate this technology; to provide data on safety and feasibility data. This trial was successfully completed with safety and feasibility data obtained for 24 patients as well as promising acute measures of longer term efficacy. This now enables AtriAN to progress to further trials in order to get regulatory approvals for sale of the device in Europe and the US. In parallel with the FIH trial development on a next generation of the device, for minimally invasive access, was also performed.
The planned first-in-human (FIH) clinical trial has now been completed with 24 patients enrolled at two different sites. This trial was performed on patients going for open-chest surgeries, such as coronary bypass, and demonstrated acutely that ablation of these neuronal sites is both feasible and safe. The patients continue to be monitored from a safety perspective and all are doing well. The study did also show that the AtriAN treatment increased the inherent resistance of the heart tissue to atrial fibrillation. This was a promising finding, helping to verify that it may indeed be an effective treatment for AFib patients – having already demonstrated safety and feasibility. Therefore the study was extended to treat an additional 12 patients – specifically patients going for open-chest surgery but who also had a medical history of AFib. The treatments went well and these patients are now being followed to see if the AFib will recur during the next 12 months.
In parallel with the open-chest FIH study, work was also performed on developing a minimally invasive version of the device. This has been designed to gain access to the outside of the heart using a small needle access pathway just beneath the chest. Bench testing of the device progressed well and the design was finalized, with prototypes being manufactured for testing in an animal model setting. These pre-clinical studies showed good performance in terms of being able to achieve minimally invasive access and navigate around the outside of the heart – as well as being able to successfully deliver the ablation energy. With some final manufacturing optimization, this device will be ready for clinical evaluation as the next step towards commercialisation.
In parallel with the open-chest FIH study, work was also performed on developing a minimally invasive version of the device. This has been designed to gain access to the outside of the heart using a small needle access pathway just beneath the chest. Bench testing of the device progressed well and the design was finalized, with prototypes being manufactured for testing in an animal model setting. These pre-clinical studies showed good performance in terms of being able to achieve minimally invasive access and navigate around the outside of the heart – as well as being able to successfully deliver the ablation energy. With some final manufacturing optimization, this device will be ready for clinical evaluation as the next step towards commercialisation.
AtriAN’s device and technology is the first developed specifically for ablating these nerve structures on the outside of the heart – importantly without damaging the healthy heart muscle tissue. Existing ablation technology has attempted to ablate these from the inside of the heart, but has only had limited success and caused a lot of unnecessary ablation damage to healthy heart tissue. The AtriAN technology is unique in that it selectively ablates the nerve structures while sparing the heart muscle tissue.
The clinical work completed within the Neuron-AFib project now positions AtriAN strongly for moving forward with further studies that will ultimately allow the device to be approved for sale in Europe and the US. This will provide clinicians with an option for improving long term outcomes – this will save cost on avoiding repeat ablations and will also make it more likely that people will opt for treatment – reducing the overall healthcare burden and improving patient wellbeing.
The clinical work completed within the Neuron-AFib project now positions AtriAN strongly for moving forward with further studies that will ultimately allow the device to be approved for sale in Europe and the US. This will provide clinicians with an option for improving long term outcomes – this will save cost on avoiding repeat ablations and will also make it more likely that people will opt for treatment – reducing the overall healthcare burden and improving patient wellbeing.