Summary: Treating patients with longstanding persistent atrial fibrillation (LSPAF) is expensive, time-consuming and in the majority of cases ineffective. LSPAF affects millions of patients in Europe and the US. The incidence of this arrhythmia is rising rapidly as western populations age, urgently necessitating better treatment options. Recent research suggests that a leading source of arrhythmia generation in LSPAF is the left atrial appendage (LAA), ablating this region reduces risk of future arrhythmia’s (BELIEF Trial) however this is a very time-consuming procedure, the benefit is usually temporary and the procedure can significantly increase the patient’s stroke risk. The AuriGen device can both electrically and physically isolate the LAA, making it the first minimally invasive implant which reduces both arrhythmia and stroke risk in AF. The AuriGen device can be implanted during PVI (pulmonary vein isolation) ablation or as a standalone procedure, using the same access sheath as used in PVI, thereby adding only minutes to the combined procedure time. The AuriGen device can increase the long-term efficacy of PVI ablation by over 50% and simultaneously eliminating the need for anti-arrythmics and anti-coagulant medicines. Our target market are highly symptomatic LSPAF patients, of which there are over 3M in US and the EU, having 400K procedures per year. The market opportunity for our device is over $5B per year & growing.
Need: Atrial Fibrillation (AF) is the most common heart rhythm disorder worldwide; a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke and heart failure. There are 16 million AF patients across Europe and the US of which 4 million have highly symptomatic and medication resistant LSPAF. Standard surgical treatment for AF is by a minimally invasive electrical therapy, catheter ablation, which destroys small areas of heart tissue causing the abnormal electrical pulses. For resistant LSPAF patients, ablations work only 30% of the time, with many being repeated at a significant cost. The incidence of AF is rising rapidly, urgently necessitating better treatment options.
Value: Extensive clinical research combined with competitive and market analysis and validation interviews with clinicians and health-service payers has ensured AuriGen’s value proposition meets all end user performance and cost benefit requirements. The Aurigen device works by permanently disrupting abnormal electrical signaling, restoring a normal sinus heart rhythm, doubling the effectiveness of existing interventions, while also filtering out blood clots from going to brain reducing the risk of a stroke. Once approved we believe the Aurigen device will eliminate the need for anti-coagulants and anti-arrhythmic medicines for the majority of patients treated, resulting in significant improvements in patient outcomes and significant long-term cost reductions associated with the management of AF.