UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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| 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.
| Item 9.01 | Financial Statements and Exhibits. |
| Exhibit |
Description | |
| 99.1 | Press Release, dated July 28, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NeuroPace, Inc. | ||||||
| Dated: July 28, 2026 | By: | /s/ Leah Akin | ||||
| Leah Akin | ||||||
| General Counsel & Corporate Secretary | ||||||