NeuroPace Receives FDA Guidance on PMA Supplement for Indication Expansion into Idiopathic Generalized Epilepsy
-- Company received communication from FDA indicating that the PMA Supplement for idiopathic generalized epilepsy is not approvable in its current form and that additional clinical evidence from the NAUTILUS trial and literature supporting the submission has been requested --
-- FDA has invited continued dialogue, and NeuroPace will be submitting a Submission Issue Request and intends to continue working with FDA on a path for approval of the submission --
-- Management will host a conference call to discuss this communication from the FDA at 4:30pm E.T./1:30pm P.T. --
NeuroPace, Inc. (Nasdaq: NPCE), a medical device company focused on transforming the lives of people living with epilepsy, today provided an update on the U.S. Food and Drug Administration review of the Company’s Premarket Approval Panel Track Supplement seeking to expand the labeled indication for the RNS® System to include patients with antiseizure medication-resistant idiopathic generalized epilepsy (IGE).
