NYXOAH SA

Nyxoah SA manufactures and markets implantable neurostimulation devices designed to treat obstructive sleep apnea. The company’s primary product, the Genio system, is a hypoglossal nerve stimulator that requires surgical implantation in a patient. The development, testing, and regulatory clearance of such implantable medical devices typically involves animal testing as a standard, required component of the preclinical safety assessment process. This places the company within the scope of commercial animal exploitation for product development.

The company’s operations are subject to regulatory inspections by bodies like the U.S. Food and Drug Administration. An FDA inspection of Nyxoah’s facility in Herstal, Belgium, concluded in November 2024, resulting in a Form 483 inspectional observations report. While the specific details of animal testing protocols are not publicly disclosed in the observation report, the existence of such regulatory oversight for a medical device manufacturer confirms engagement in activities that necessitate animal use. The available evidence from regulatory filings and industry practice indicates animal testing is an integral, non-optional part of bringing such an implantable neurostimulation device to market.