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

Company: Nyxoah SA
Filing Date: 2025-08-11
Form: 6-K
Chunk 6
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 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. Our success depends
entirely upon its market acceptance and adoption by physicians, payors and patients. The Genio system may not gain commercial acceptance
in target markets. If we fail to gain and maintain commercial market acceptance of the Genio system in our target markets, for instance,
because of insufficient price and reimbursement levels from government and third-party payors, competition, or the inability to demonstrate
the benefits and cost-effectiveness of the Genio system compared to other products available on the market, the amount of revenue generated
from sales of the Genio system in the future could continue to be limited, and could even decrease over time. Even if third-party payor
coverage is provided, the approved reimbursement amounts may not be high enough to allow us to establish and maintain pricing sufficient
to realize a meaningful return on our investment.

These and other factors present
obstacles to commercial acceptance of the Genio system in target markets and could lead to our failure, or a substantial delay, in gaining
significant market acceptance of the Genio system in target markets, which could affect our ability to generate revenue. Any failure of
the Genio system to achieve meaningful market acceptance will harm our business and future prospects.

We may not receive, or may experience delays in receiving, the necessary marketing authorizations or certifications for our Genio system or any future product candidates, and failure to timely obtain necessary marketing authorizations or certifications for our product candidates could have a material adverse effect on our business.

In the United States, before
we can market a new medical device, or a new use of, or other significant modification to, an existing, marketed medical device, we must
first receive either clearance under Section 510(k) of the Federal Food, Drug, and Cosmetic Act, or the FDCA, approval of a premarket
approval, or PMA, application or grant of a De Novo classification request from the FDA, unless an exemption applies. In the 510(k) clearance
process, before a device may be marketed, the FDA must determine that a proposed device is “substantially equivalent” to a
legally marketed “predicate” device, which may be a device that has been previously cleared through the 510(k) process, a
device that was legally marketed prior to May 28,