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Problem. Dementia is a major public health issue, with no effective, efficient, or safe treatments currently available to cure or delay its onset. Breakthrough. Elevvo offers a groundbreaking solution, becoming the first validated medical device to treat mild cognitive impairment (MCI) and delay the onset of dementia. This breakthrough is based on the combination of two innovative treatments that combine neurotechnology and artificial intelligence (AI). The first treatment utilizes active neuromodulation, while the second involves passive auditory stimulation during sleep. Innovation. Elevvo introduces a new standard in neuro-therapeutics, with two evidence-based treatments that can be self-managed at home, with remote supervision by physicians. Key components are: 1) HomeKit: A user-friendly neuroheadset paired with a mobile tablet, equipped with 4G/5G connectivity for delivering AI-driven treatments. 2) Cloud-based software: A system to manage treatments and a web-based portal, allowing physicians to monitor patient progress remotely. Current State. In Phase 1 and Phase 2a clinical trials, Elevvo demonstrated that patients could safely and independently use the HomeKit. Both treatments also showed significant improvements in biomarkers related to working memory, episodic memory, and memory consolidation in the target population (MCI patients). The results have qualified for a multicenter randomized clinical trial Phase 2b clinical trial currently under execution. Path Forward. Support from the EIC will enable the progression from TRL 6 to 9, culminating in international multicenter Phase 3 clinical trials, scaling up, and moving towards the go-to-market phase.
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