Core Insights - NeuroPace, Inc. has completed enrollment and implant procedures in its feasibility investigational device exemption (IDE) study of the RNS® System for treating Lennox-Gastaut Syndrome (LGS), a severe form of childhood-onset epilepsy [1][4] - The IDE study aims to evaluate the safety and effectiveness of the RNS System, which has previously shown success in treating medically intractable focal onset seizures in adults [2][3] - The study is funded by a $9.3 million NIH grant and involves 20 patients aged 12 and older with LGS and drug-resistant generalized onset seizures [3] Company Overview - NeuroPace is a commercial-stage medical device company based in Mountain View, California, focused on transforming the lives of individuals with epilepsy through innovative treatments [6] - The RNS® System is the first and only FDA-approved brain-responsive neuromodulation system, designed to provide personalized, real-time treatment by continuously monitoring brain activity [5][6] - The system has demonstrated significant reductions in seizure frequency and improvements in quality of life and cognition without stimulation-related side effects [5] Industry Context - LGS is a debilitating seizure disorder with 85% of affected individuals continuing to experience seizures into adulthood despite aggressive treatment, highlighting the urgent need for innovative treatment options [4] - The RNS System's technology represents a paradigm shift in the treatment of drug-resistant epilepsy, potentially offering better outcomes for a large population suffering from various brain disorders [5][6]
NeuroPace Completes Enrollment in Feasibility Study of RNS System for Lennox-Gastaut Syndrome