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

Company: Nyxoah SA
Filing Date: 2025-08-11
Form: 6-K
Chunk 11
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 ear, nose,
and throat or neuromodulation and 11 of the managers having prior HGNS experience. However, we have no experience marketing and selling
the Genio system in the United States. To commence commercial launch will require us to continue to hire, develop, grow and retain a U.S.
marketing and sales organization. To do so will require significant investment in recruiting and training as we ramp up to a U.S. commercial
launch. There is significant competition for marketing and sales personnel experienced in medical device sales. Once we hire such personnel,
we expect to provide them with in-depth training, which can be lengthy, because it will require significant education for new marketing
and sales representatives to achieve the level of clinical competency with the Genio system that physicians expect. Upon completion of
training, our sales representatives will require lead time in the field to grow their network of accounts and achieve productivity levels
we expect them to reach in each individual territory. If we are unable to attract, motivate, develop and retain a sufficient number of
qualified sales personnel, and if our sales representatives do not achieve the productivity levels we expect them to reach, our revenue
will not grow at the rate we expect, and our financial performance will suffer.

If the commercial launch
of the Genio system in the United States or another jurisdiction for which we recruit a sales force and establish marketing capabilities
is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This
may be costly, and our investment would be lost if we cannot retain or reposition our sales and marketing personnel. In addition, our
sales efforts may be hindered in target markets if we fail to develop and, as applicable, obtain marketing authorization for complementary
products.

We may also decide to target
certain markets indirectly via distributors or other arrangements. If we are unable to find suitable distribution partners, lose these
distribution partners or if our distribution partners fail to sell our products in sufficient quantities, on commercially viable terms
or in a timely manner, the commercialization of the Genio system could be materially harmed, which could prevent us from achieving or
maintaining profitability.

The Genio system is still unapproved in certain significant markets, and seeking and obtaining regulatory authorization or certification for active implantable medical devices can be a long, expensive and uncertain process.

Applications for prior regulatory
authorization in the countries where we intend to sell or market the Genio system and any other products we develop may require extensive
non-clinical