Periodic Reporting for period 4 - LAA-START (Left Atrial Appendage Electrical Isolation via Bio-photonic Optical Confirmation to Treat Persistent Atrial Fibrillation)
Período documentado: 2021-07-01 hasta 2022-03-31
Problem: Everyday millions of patients suffer with atrial fibrillation (AF), a condition characterized by an irregular heartbeat or arrhythmia which can lead to stroke, dementia, heart failure and death. Unfortunately for the majority of AF patients with persistent disease, the current treatment options are routinely ineffective. Persistent AF affects over 12M patients in Europe and the US and the incidence of this arrhythmia is rising rapidly as western populations age, urgently necessitating better treatment options.
Clinical Evidence: Recent research suggests that a leading source of arrhythmia generation in PAF is the left atrial appendage (LAA), ablating this region a procedure termed LAA electrical isolation (LAAEI), reduces risk of future arrhythmias by over 70%. However, LAA-electrical isolation is not without its challenges: its slow, the benefit can be temporary due to late electrical reconnections, requires complex mapping and can actually increase a patient’s stroke risk due LAA paralysis. The AuriGen device addresses all these challenges, while making the procedure faster, safer and easier to perform.
Solution: The AuriGen device is a fast single shot option to permanently electrically isolate and occlude the LAA, with our unique integrated sensor confirming permanent electrical isolation during the procedure, eliminating the need for complex mapping. The AuriGen device will open up the procedure to a wider group of physicians and make it the first trans-septal implant which reduces both arrhythmia and stroke risk in PAF. The implantation adds only minutes to the PVI procedure time, but has the potential to eliminate the need for anti-arrythmic’s and anti-coagulant medicines in the majority of patients.
Opportunity: Our target market is highly symptomatic PAF patients, of which there are over 3 million in US and the EU. We will initially target the 200K patients who are having repeat ablations due to AF re-occurrence after their first pulmonary vein ablation. With an average selling price similar to existing LAA occluders, the market opportunity for our device is $3B per annum and growing
Competition: There are many device and pharmaceutical companies looking to address AF, our nearest competitor are LAA occluders such as Boston Scientific’s “Watchman” and Abbotts “Amulet” which reduce stroke risk but have no effect on the underlying AF. AuriGen Medical’s patient centric approach to treating both stroke and arrhythmia will ensure our technology is highly disruptive, with the potential to eliminate the existing left atrial appendage occlusion market once approved.
Clinical Evidence: Recent research suggests that a leading source of arrhythmia generation in PAF is the left atrial appendage (LAA), ablating this region a procedure termed LAA electrical isolation (LAAEI), reduces risk of future arrhythmias by over 70%. However, LAA-electrical isolation is not without its challenges: its slow, the benefit can be temporary due to late electrical reconnections, requires complex mapping and can actually increase a patient’s stroke risk due LAA paralysis. The AuriGen device addresses all these challenges, while making the procedure faster, safer and easier to perform.
Solution: The AuriGen device is a fast single shot option to permanently electrically isolate and occlude the LAA, with our unique integrated sensor confirming permanent electrical isolation during the procedure, eliminating the need for complex mapping. The AuriGen device will open up the procedure to a wider group of physicians and make it the first trans-septal implant which reduces both arrhythmia and stroke risk in PAF. The implantation adds only minutes to the PVI procedure time, but has the potential to eliminate the need for anti-arrythmic’s and anti-coagulant medicines in the majority of patients.
Opportunity: Our target market is highly symptomatic PAF patients, of which there are over 3 million in US and the EU. We will initially target the 200K patients who are having repeat ablations due to AF re-occurrence after their first pulmonary vein ablation. With an average selling price similar to existing LAA occluders, the market opportunity for our device is $3B per annum and growing
Competition: There are many device and pharmaceutical companies looking to address AF, our nearest competitor are LAA occluders such as Boston Scientific’s “Watchman” and Abbotts “Amulet” which reduce stroke risk but have no effect on the underlying AF. AuriGen Medical’s patient centric approach to treating both stroke and arrhythmia will ensure our technology is highly disruptive, with the potential to eliminate the existing left atrial appendage occlusion market once approved.
An iterative design approach has been applied to the key components of the device; the ablation system, implant, sensor and delivery system to establish the key design inputs and move towards a defined design specification. The Clinical and Regulatory strategy have been outlined and validated, together with a defined Market Access approach.
The AuriGen device is designed to address the challenges of LAA electrical isolation, while simultaneously making the procedure faster, safer and more intuitive. is a quick single shot option to permanently electrically and mechanically isolate the LAA in patients with persistent AF, without the need for mapping. Transcending the limitations of empirical isolation and occlusion devices. To successfully address PAF it is essential to simultaneously treat both the arrhythmia and the stroke risk, this is impossible with the existing technology. We have created a unique device which combines both catheter ablation and LAA occlusion, with the potential to permanently restore normal heart rhythm while filtering out clots from the LAA, reducing the possibility of stroke.