On Mar. 18, 2026, Nia Therapeutics announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Smart Neurostimulation System (SNS) for the treatment of episodic memory loss in adult patients with prior moderate-to-severe traumatic brain injury (TBI) and persistent memory deficits.

The SNS is the first device to receive Breakthrough designation for TBI-related memory loss. There is significant unmet need in this indication, with no FDA-cleared or approved therapies to treat memory loss and more than 4.3 million Americans living with TBI-related disability.

The SNS is a fully implantable, wireless neuromodulation platform that records neural activity from 60 channels across four brain regions. Using machine-learning classifiers trained on each patient’s own brain signals, the device detects moments of impaired memory encoding in real time and delivers targeted electrical stimulation to the lateral temporal cortex.

This closed-loop approach improved recall by 19% in a randomized, sham-controlled study of neurosurgical patients with epilepsy and a history of moderate-to-severe TBI. Randomly timed stimulation produced no benefit, underscoring the importance of delivering therapy at the right moment.

Nia Therapeutics develops implantable brain-computer interfaces for memory disorders. Founded in 2018, the company’s SNS platform enables closed-loop neuromodulation by detecting brain states linked to impaired memory encoding and delivering targeted stimulation.