Nia Therapeutics’ neurostimulation device for addressing memory loss has secured breakthrough device designation from the US Food and Drug Administration (FDA), paving the way towards the company’s application for an investigational device exemption (IDE) study.
US-based Nia’s Smart Neurostimulation System (SNS) for episodic memory loss treatment in adults with prior moderate-to-severe traumatic brain injury (TBI) and persistent memory deficits is the first device to receive FDA breakthrough designation for TBI-related memory loss.
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SNS records neural activity from 60 channels across four brain regions. Applying AI to patients’ individual brain signals, the device detects moments of impaired memory encoding in real time. To remediate these signals, SNS delivers targeted electrical stimulation to the lateral temporal cortex, the brain region critical in processing semantic memory and other functions such as processing auditory information.
In a sham-controlled study, SNS’s closed-loop approach improved recall by 19% in patients with epilepsy and a history of moderate-to-severe TBI.
According to the US Centers for Disease Control and Prevention (CDC), around 4.3 million people in the US live with TBI-related disability.
With the breakthrough designation in hand, which avails Nia of prioritised review and increased interaction with the FDA, the company now intends to file an IDE application later this year to support the initiation of a first-in-human (FIH) study of the SNS.
This development builds on the company’s completion of the first in vivo validation of SNS in a large animal model. Results of the preclinical validation study were published in Brain Stimulation in January 2026. In three sheep models, Nia’s SNS demonstrated stable performance in neural- state decoding and confirmed the system’s reliability in physiological signal modulation.
Nia Therapeutics CEO Michael Kahana said: “The breakthrough designation validates the approach we’ve spent a decade building – that memory can be improved by listening to the brain and stimulating at precisely the right moment.
“This designation provides a framework to work closely with the FDA as we bring this technology from the laboratory into the clinic.”
According to GlobalData analysis, the global neurology devices market is growing at a CAGR of 6.7% and is projected to reach a valuation of around $26.3bn in 2035, up from $13.8bn in 2025.
Alongside memory loss, the application of neuromodulation is advancing in the treatment of other conditions such as tinnitus, substance use disorder, Parkinson’s disease and epilepsy.
