Nia Therapeutics’ Smart Neurostimulation System Receives FDA Breakthrough Device Designation to Treat Memory Loss
Shots:
- The US FDA has granted BDD to Smart Neurostimulation System (SNS) for the treatment of episodic memory loss in adults with prior mod. to sev. traumatic brain injury (TBI) & persistent memory deficits
- The SNS is a fully implantable, closed-loop neuromodulation system that records neural activity from 60 channels across four brain regions & delivers targeted stimulation to the lateral temporal cortex
- SNS has improved recall by 19% in a sham-controlled study of neurosurgical pts with epilepsy & a history of TBI, while random stimulation showed no benefit, plus the company is planning to file an IDE application in 2026
Ref: Businesswire | Image: Nia Therapeutics | Press Release
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