The FDA has granted Breakthrough Device Designation to Nia Therapeutics for its Smart Neurostimulation System, a fully implantable brain-computer interface designed to treat memory loss caused by traumatic brain injury. The designation, announced on March 13, marks the first time the FDA has applied the pathway to a device targeting TBI-related cognitive impairment.
The system is a 60-channel wireless implant that uses machine-learning classifiers to detect moments of impaired memory encoding and deliver targeted electrical stimulation to the lateral temporal cortex in real time. That channel count represents an order-of-magnitude increase over commercially available neurostimulation devices: NeuroPace’s RNS system for epilepsy offers up to six channels, and Medtronic’s Percept adaptive DBS platform provides four.
“Memory depends on coordinated activity across widespread brain networks, so we built a device that can sense and respond across the entire network,” said Daniel Rizzuto, Nia’s co-founder and chief technology officer, in a statement.
In a randomised, sham-controlled study in neurosurgical patients with epilepsy and a history of moderate-to-severe TBI, the system produced a 19 percent improvement in recall. Random stimulation showed no benefit, supporting the idea that the improvement was driven by the timing and targeting of the intervention rather than the electrical current alone.
The clinical work builds on a preclinical validation study published in Brain Stimulation in January 2026. That study, conducted in three freely moving sheep, demonstrated that the system’s onboard classifiers could distinguish movement states with high accuracy (area under the curve exceeding 0.95) and that increasing stimulation amplitude produced measurable changes in alpha-band and gamma-band neural power at target sites.
Nia was founded in 2018 by Rizzuto and Michael Kahana, the Edmund J. and Louise W. Kahn Term Professor of Psychology at the University of Pennsylvania. Their work grew out of research at Penn’s Computational Memory Lab, originally funded by DARPA, where the pair first demonstrated that personalised neurostimulation could improve memory performance. The company, based in Radnor, Pennsylvania, has raised approximately $28.6 million to date, including a $15.6 million Series A round in late 2021 backed by Point72 Ventures.
“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,” said Kahana.
The designation gives Nia access to a prioritised FDA review pathway with increased agency interaction and senior management involvement in future submissions. The company plans to file an Investigational Device Exemption application this year to support a first-in-human early feasibility study.
If successful, the system would represent a meaningful expansion of the BCI therapeutic landscape. The vast majority of brain-computer interfaces in clinical development target motor function — restoring movement or communication in patients with paralysis. Nia’s device is aimed squarely at cognition, a domain where the neural targets are distributed rather than localised and where few implantable systems have been tested.
The CDC estimates that 4.3 million people in the United States live with TBI-related disability, many of whom experience persistent memory deficits that limit daily functioning. No implantable device is currently approved for this population.