Company: NYXH
Filing Date: 2025-08-11
Form Type: 6-K
Source: 0001104659-25-075831
Chunk: 12

Company: Nyxoah SA
Filing Date: 2025-08-11
Form: 6-K
Chunk 12
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, clinical and performance testing, all of which must be undertaken in accordance with the requirements of regulations established
by the relevant regulatory agencies, which are complex and have become more stringent over time. We may be adversely affected by potential
changes in government policy or legislation applicable to implantable medical devices. At the date of this prospectus supplement, we have
received certification to market the Genio system and the Genio 2.1 system in the EU member states through CE-Marking and Israeli Medical
Devices and Accessories, or AMAR. CE-Marking is also valid in the European Economic Area, or EEA (which consists of the 27 EU member states
plus Norway, Liechtenstein and Iceland). On August 8, 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.

Furthermore, obtaining and
maintaining regulatory approval of the Genio system in some jurisdictions, such as the United States and Europe, does not guarantee that
we will be able to obtain or maintain regulatory approval in any other jurisdiction, whereas a failure or delay in obtaining regulatory
approval in one jurisdiction may have a negative effect on the regulatory approval process in others. For example, even if the FDA grants
marketing approval of a product, similar foreign regulatory authorities must also approve the manufacturing, marketing and promotion of
the product candidate in those countries. Approval and licensure procedures vary among jurisdictions and can involve requirements and
administrative review periods different from, and greater than, those in the United States, Europe or Israel, including additional nonclinical
studies or clinical trials. In many jurisdictions outside the United States, a product candidate must be approved for reimbursement before
it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our products is also subject to
approval. If we fail to comply with the regulatory requirements in international markets and/or receive applicable marketing approvals,
our target market will be reduced and our ability to realize the full market potential of our products and product candidates will be
harmed.

We or the third parties upon which we depend may be adversely affected by general political, unstable market and economic conditions and other events beyond our control and our business continuity and disaster recovery plans