Nia Therapeutics
Allston, Massachusetts company developing the Smart Neurostimulation System, a 60-channel closed-loop brain implant for memory loss after traumatic brain injury. Received FDA Breakthrough Device Designation on 13 March 2026; the device is preclinical, with an IDE application planned for 2026.
Overview
Nia Therapeutics was co-founded in 2018 by Michael Kahana, a University of Pennsylvania memory neuroscientist who serves as chief executive, and Daniel Rizzuto, president and chief technology officer. The company grew out of Kahana’s Computational Memory Lab at Penn, which DARPA’s Restoring Active Memory programme funded from 2014, and it licensed algorithms from that lab.
Technology
The Smart Neurostimulation System (SNS) is a fully implantable wireless platform with four depth leads, a processor worn behind the ear and cloud analytics. It records from 60 channels and triggers closed-loop stimulation of the lateral temporal cortex when it detects impaired memory encoding. Two studies support it: a 2023 study using an externalised research prototype, which reported a 19 per cent improvement in verbal recall in epilepsy patients with a history of TBI, and a sheep study published in December 2025 that validated the implant hardware. The SNS has not yet been implanted in a person.
Latest
On 13 March 2026 the FDA granted the SNS Breakthrough Device Designation for episodic memory loss in adults with prior moderate-to-severe traumatic brain injury, which the company describes as the first such designation for TBI-related memory loss. Nia plans to file an Investigational Device Exemption application in 2026 to begin a first-in-human feasibility study.
Why it matters
The visible BCI pipeline centres on paralysis. Nia targets acquired memory loss in people who often keep motor function and live independently, a population far larger than spinal cord injury or ALS. Nia cites a CDC estimate of more than 4.3 million Americans living with TBI-related disability. The IDE filing and the design of the first human study are the next signals.