Company: NYXH
Filing Date: 2025-03-26
Form Type: 6-K
Source: 0001104659-25-027917
Chunk: 1

Company: Nyxoah SA
Filing Date: 2025-03-26
Form: 6-K
Chunk 1
---
 the Company’s
Premarket Approval (“PMA”) application for the Genio® system.

The Approvable Letter means that the
Company’s application for marketing the device in the United States substantially meets the requirements of the Federal Food,
Drug and Cosmetic Act and the FDA’s PMA implementing regulations codified at 21 C.F.R. Part 814, and the FDA can approve the
application subject to satisfactory completion of a manufacturing facilities, methods and controls review.

This U.S. FDA decision does not impact Genio’s
CE Mark or the Company’s ongoing commercial activities in Europe, where the device is marketed for both Complete Concentric Collapse
(“CCC”) and non-CCC patients.

The information included under the heading FDA Issues Approvable Letter to Nyxoah SA for Genio® System shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-285960,
333-261233and333-269410) and Form F-3 (Registration Numbers 333-285982 and 333-268955) of the Company (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

Press Release

On March 26, 2025, the Company issued a press release titled “FDA
Issues Nyxoah an Approvable Letter for its Genio® System” a copy of which is attached to this Form 6-K as Exhibit 99.1.

The information in the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

Exhibits

<div align='center'>SIGNATURES</div>

Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

| Date: March 26, 2025 | NYXOAH SA 
 By:       | /s/