Nia Therapeutics announced that it received FDA breakthrough device designation for its Smart Neurostimulation System (SNS).
The device won the breakthrough nod for the treatment of episodic memory loss in adult patients with prior moderate-to-severe traumatic brain injury (TBI) and persistent memory deficits.
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According to a news release, SNS becomes the first device to receive breakthrough designation for TBI-related memory loss. The company says no current FDA-cleared or approved therapies exist to treat memory loss.
Nia Therapeutics designed its device to record neural activity from 60 channels across four brain regions. The company says this provides a significant increase over commercially available neurostimulation devices. It pointed to the NeuroPace RNS system (up to six channels) and the Medtronic Percept adaptive deep brain stimulation (DBS) system (up to four).
The AI-guided device uses machine learning classifiers trained on each patient’s own brain signals. It detects moments of impaired memory encoding in real time, then delivers targeted electrical stimulation to the lateral temporal cortex.
Nia says its 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, the company said. This demonstrated the importance of therapy delivery at the right moment.
Breakthrough designation grants prioritized review and increased FDA interaction. Now, it plans to work toward an investigational device exemption (IDE) application for a first-in-human early feasibility study.
Michael Kahana, co-founder and CEO of Nia Therapeutics, 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.”
Daniel Rizzuto, co-founder and CTO of Nia Therapeutics, said:
“Memory depends on coordinated activity across widespread brain networks—so we built a device that can sense and respond across the entire network. With 60 channels across four brain regions, the SNS offers an order of magnitude improvement over currently approved DBS devices.”
Dr. Ramon Diaz-Arrastia, Presidential Professor of Neurology and Director of the TBI Clinical Research Center at the University of Pennsylvania, and advisor to Nia Therapeutics, said:
“Patients with TBI-related memory loss represent a profoundly underserved population. Their disability is invisible but devastating—it affects the ability to work, maintain relationships, and live independently. We are committed to bringing them the first treatment that directly restores the capacity to form new memories.”
