Inner Cosmos reports early results for its skull-embedded depression implant
In a three-person FDA early feasibility study, all participants improved and two reached remission, according to the company.
Inner Cosmos has completed its FDA early feasibility study of a penny-sized stimulator embedded in the skull bone for treatment-resistant depression. According to the company, all three participants improved, by 41% to 83% from baseline. Two reached remission, one of whom has stayed in remission for more than 18 months, and there were no serious adverse events. It plans pivotal trials in the US and Australia.
These are company-reported results from a very small, unblinded study, so larger controlled trials are needed to confirm the benefit.
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