Atrial Fibrillation (AF) is an irregular heartbeat that can lead to blood clots, high risk of stroke and heart failure. AF is caused by abnormal electrical activity in the heart. There are 10.7 million AF patients across Europe and the US, 3.6 million are classified as having Persistent AF (PAF). Surgical treatment for AF is a minimally invasive electrical therapy which destroys heart tissue causing the abnormal electrical pulses. For PAF patients, this works only 30% of the time. Approximately 72% of PAF patients require at least one redo procedure, amounting to €13.5 billion in wasted healthcare costs. Success rates are doubled if electrical activity in a part of the heart “the Left Atrial Appendage” (LAA), is shut down. But this increases stroke risk from blood clots as the LAA is now incapable of muscle contraction to maintain blood flow. LAA implants, “occlusion devices” fit across the opening of the LAA to filter the blood and prevent clots from entering the blood stream. However, fitting an occlusion device during the same procedure as LAA electrical isolation doubles procedure time (to 7 hours) making it non-financially viable for health services and too high risk for patients.
We have developed a unique, minimally invasive cardiac implant which permanently electrically and mechanically isolates the LAA in a one-shot procedure: treating both the stroke and arrhythmia risk associated with PAF with no increase in surgery time.
EU and US PAF represents a $5bn/yr market opportunity. We will enter the market directly in our target Tier 1 European markets (Germany, France, Italy and UK). We will scale using specialist distributors to expand into further European, US and other international markets.
In this Phase 2 we will complete the technical, pre-clinical and first in human clinical studies required to achieve CE approval in Europe as well as market development work for commercial launch.
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