Common Stock, $0.001 par value per share
- Symbol
- NPCE
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 9.01 · 8-K
Neuropace, Inc.
NPCENASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On July 28, 2026, the Company issued a press release announcing that it had received notification from the U.S. Food and Drug Administration (FDA) that its Premarket Approval Supplement (PMA-S) seeking to expand the labeled indication for the RNS System to include patients with antiseizure medication-resistant idiopathic generalized epilepsy (IGE) with generaliz…
Company context
Based in Mountain View, Calif., NeuroPace is a medical device company focused on transforming the lives of people living with epilepsy by reducing or eliminating the occurrence of debilitating seizures. Its novel and differentiated RNS System is the first and only commercially available, brain-responsive platform that delivers personalized, real-time treatment at the seizure source. This platform can drive a better standard of care for patients living with drug-resistant epilepsy and has the potential to offer a more personalized solution and improved outcomes to the large population of patients suffering from other brain disorders.
Current securities
Registered securities in this filing
NeuroPace Inc · 8-K · Filed 2026-07-28
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On July 28, 2026, the Company issued a press release announcing that it had received notification from the U.S. Food and Drug Administration (FDA) that its Premarket Approval Supplement (PMA-S) seeking to expand the labeled indication for the RNS System to include patients with antiseizure medication-resistant idiopathic generalized epilepsy (IGE) with generalized tonic-clonic (GTC) seizures is not approvable in its current form and that additional clinical evidence supporting the submission has been requested. The Company reported that the FDA has invited continued dialogue, and the Company intends to continue working with FDA on a path for approval of the submission. A copy of the press release is attached hereto as Exhibit 99.1.
The foregoing information in this Item 7.01 (including the exhibit hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.
Filed exhibits (1)
EX-99.1 2 d138221dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 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. - Mountain View, Calif. - July 28, 2026 - 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…
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