Nia Therapeutics has received FDA Breakthrough Device Designation for its Smart Neurostimulation System, an AI-guided brain implant designed to treat episodic memory loss in adults with moderate-to-severe traumatic brain injury. The device is the first to receive breakthrough designation for TBI-related memory loss, addressing an unmet need affecting over 4.3 million Americans living with TBI-related disability. The fully implantable system records neural activity from 60 channels across four brain regions, using machine-learning to detect moments of impaired memory encoding and deliver targeted electrical stimulation. A randomised, sham-controlled study showed the closed-loop approach improved recall by 19% in neurosurgical patients. Founded in 2018, Nia Therapeutics plans to submit an Investigational Device Exemption application this year to support a first-in-human early feasibility study.

Nia Therapeutics: The company raised $15.6 million of venture funding from Ben Franklin Technology Partners, Paeonia Group and other undisclosed investors on July 17, 2025.