Neuralink PRIME trial second cohort opens enrollment — 25 additional patients across 4 US sites
Summary
Neuralink announced the opening of a second enrollment cohort in the PRIME trial, expanding from 1 to 4 US implanting centers and targeting 25 additional patients across ALS, spinal cord injury, and brainstem stroke indications. Updated inclusion criteria now include patients with amyotrophic lateral sclerosis who retain some residual hand movement, expanding eligibility significantly.
Why it matters
Expanding to 4 sites and 25 patients dramatically accelerates the clinical evidence generation needed for FDA De Novo clearance. Multi-center data is also significantly more persuasive to regulators than single-site results, addressing the primary concern about generalizability of Neuralink's initial PRIME data.
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