Company: NYXH
Filing Date: 2025-08-11
Form Type: 6-K
Source: 0001104659-25-075831
Chunk: 7

Company: Nyxoah SA
Filing Date: 2025-08-11
Form: 6-K
Chunk 7
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1976 (pre amendments device), a device that was originally on the U.S. market pursuant
to an approved PMA and later down-classified, or a 510(k) exempt device. To be deemed substantially equivalent, the proposed device must
have the same or similar intended use as the predicate device, and either have the same technological characteristics as the predicate
device or have different technological characteristics and not raise different questions of safety or effectiveness from the predicate
device. Clinical data may be required to support substantial equivalence. In the process of obtaining PMA approval, the FDA must determine
that a proposed device is safe and effective for its intended use based on extensive data, including, but not limited to, technical, preclinical,
clinical trial, manufacturing and labeling data. The PMA process is typically required for devices that are deemed to pose the greatest
risk, such as life sustaining, life supporting or implantable devices. In the De Novo classification process, a manufacturer of a novel
device under the FDA that would otherwise be automatically classified as Class III and require the submission and approval of a PMA prior
to marketing can request an initial classification of the device as Class I or Class II based on evidence that the device in fact presents
a low or moderate risk. If the FDA grants the De Novo classification request, the applicant receives authorization to market the device.
If the De Novo process results in the classification of a device as Class II, the authorized device may be used subsequently as a predicate
device for future 510(k) submissions.

The PMA approval, 510(k)
clearance and De Novo classification processes can be expensive, lengthy and uncertain. The FDA’s 510(k) clearance process can take
anywhere from three to 12 months or longer to complete. The process of obtaining a PMA or De Novo classification is much more costly and
uncertain than the 510(k) clearance process and generally takes from one to three years, or even longer, from the time the application
is submitted to the FDA. In addition, PMAs and De Novo classification requests generally require the applicant to have conducted one or
more clinical trials. Despite the time, effort and cost expended in seeking a marketing authorization, there is no assurance that the
FDA will grant it. Any delay or failure to obtain necessary regulatory marketing authorizations could harm our business. Furthermore,
even if we are granted such marketing authorizations, they may include significant limitations on the indicated uses for the device, which