Company: NYXH
Filing Date: 2025-08-11
Form Type: 6-K
Source: 0001104659-25-075831
Chunk: 10

Company: Nyxoah SA
Filing Date: 2025-08-11
Form: 6-K
Chunk 10
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 or Notified Bodies can delay, limit or deny future marketing authorization or certification of a device for many reasons,
including:

| · | our inability to demonstrate to the satisfaction of the FDA or the applicable regulatory entity or Notified 
 Bodies that our products are safe and effective for their intended uses;                                    |

| · | the disagreement of the FDA, foreign regulatory authorities or other foreign (regulatory) body with the                     
 design or implementation of our clinical trials or the interpretation of data from non-clinical studies or clinical trials; |

| · | serious and unexpected adverse device effects experienced by participants in our clinical trials; |

| · | the data from our non-clinical studies and clinical trials may be insufficient to support clearance, certification, 
 De Novo classification or approval, where required;                                                                 |

| · | our inability to demonstrate that the clinical and other benefits of the device outweigh the risks; |

| · | the manufacturing process or facilities we use may not meet applicable requirements; and |

| · | the potential for approval policies or regulations of the FDA or foreign regulatory authorities to change           
 significantly in a manner rendering our clinical data or regulatory filings insufficient for clearance or approval. |

We have limited experience marketing and selling our Genio system, and if we are unable to expand, manage and maintain our direct sales and marketing organization, we may not be able to generate revenue growth.

We have only limited experience
in marketing and selling our Genio system. To achieve commercial success, we will need to keep expanding our internal sales and marketing
organization to commercialize the Genio system in markets that we will target directly, such as Germany, Austria and Switzerland. Expanding
our sales and marketing team further will entail recruiting additional managerial, operational, financial and other employees, which is
expensive and time-consuming and could delay product launches.

On [ ], 2025, we announced
that the U.S. Food and Drug Administration, or FDA, granted approval of the Genio® system for a subset of patients with moderate to
severe Obstructive Sleep Apnea (OSA) with an Apnea-Hypopnea Index (AHI) of greater than or equal to 15 and less than or equal to 65. At
the launch of the Genio system in the U.S., we intend to cover approximately 30% of the existing U.S. HGNS market with 25 territory managers.
These territory managers have an average of more than ten years of experience, with all of the managers having experience with