The state-of-the-art is divided into devices which occlude/block the LAA (mitigate stroke-risk) and ablation-catheter therapy devices(restore normal heart-rhythm).LAA occlusion-devices are sub-categorized into 1) Minimally invasive intra-cardiac devices,placed by interventional-cardiologists &2)Epicardial-devices which close the LAA from outside the heart;deployed by cardio-thoracic surgeons (open-heart-surgery). Implantation-techniques are highly specialized,outside skill-sets of most interventional-cardiologists,must have a cardiologist and thoracic-surgeon present, and must be performed in specialist-cardiothoracic-centers, of which just 15-20 exist in the US, 2 in UK. Currently all devices are/have sought approval for AF-stroke-prevention and have not shown effectiveness treatment of AF arrhythmia.
AuriGen Benefits over State-of-the-Art:Environmental:Fewer procedures due to more effective treatment enable hospital energy-savings& hospital and patient travel emission reductions.Societal:Improved outcomes and quality-of-life for thousands of patients in Europe,USA and ultimately millions globally. AuriGen is the only fully percutaneous non-invasive device, enabling full electro-mechanical LAA isolation in one simple PAF procedure to reduce stroke-risk & address arrhythmia;increasing long-term procedural success from 28% to 56%min.
AuriGen device features exceed existing solutions; similar deployment to Watchman, facilitating rapid adoption; incorporation of RF-electrodes and oxygen-sensors is a unique confirmation of permanent electrical isolation for confidence in procedural success;enhanced implant safety;one-shot procedure shortens surgery and improves patient safety.
Expected Project-Results:Completion of commercialization activities including: Concept-Select/Design Freeze/Verification/Validation/Pre-Clinical/FIH evaluation/CE Approval/Commercialization/FDA Pivotal Trial
Impact: Initial CE mark focus on German,UK,Italian,French markets(66% of medical-device-sales in Europe), subsequent wider-adoption across EU(2022),US(FDA approval expected 2023) and worldwide.
Redo cardiac-ablations can cost €46K with approximately 72% of PAF patients requiring at least one redo; totaling €13.2billion in wasted healthcare-costs. The AuriGen device can reduce redo-procedures to 27% reducing healthcare costs to €5billion, a total-healthcare saving of €3.9 billion or >€9,750 saving-per-patient.Reimbursement codes for LAA Closure Therapy are in place.The electrical-therapy market is relatively new; valued over $3.6 billion, growing at 9-11% p.a.The global ablation market is predicted to double to $2.5 billion, through an increase in AF procedures(1million today to 1.7million by 2022). The US-Center-for-Disease-Control estimates the total US AF population is approximately 6million;10.2million in EU; projected to increase to an estimated 12million US cases 2030.P
