Cadence Neuroscience Gains FDA Approval for Epilepsy Study

Cadence Neuroscience has received approval from the U.S. Food and Drug Administration (FDA) for an Investigational Device Exemption (IDE), allowing the initiation of a multicenter clinical study.

The study will evaluate Cadence's investigational Biomarker Targeted Stimulation (BTS) therapy in 45 pediatric and adult patients diagnosed with focal drug-resistant epilepsy. The therapy is designed to utilize patient-specific neural biomarkers to guide stimulation and measure brain responses in real-time.

The multicenter trial, named BTSEE, will be conducted at up to 10 comprehensive epilepsy centers across the United States. The research aims to gather clinical evidence to support a future Humanitarian Device Exemption (HDE) application.

Cadence's technology is based on research from the Mayo Clinic, and prior retrospective analyses have indicated promising outcomes. This new study seeks to prospectively confirm these findings across multiple institutions. The company seeks to generate data that could benefit patients whose epilepsy does not respond to current treatments.