Core Viewpoint - Nyxoah's Genio system has received a significant reimbursement boost from Medicare, enhancing its commercial viability in the U.S. market, particularly in outpatient settings where Medicare is prevalent [2][4]. Product and Technology Mechanism - Genio utilizes hypoglossal nerve stimulation (HNS) to treat obstructive sleep apnea (OSA) by stimulating the hypoglossal nerve to maintain airway patency, serving as a key alternative to CPAP [6]. - The system features a single incision implantation, reducing surgical trauma and time, with reimbursement rates for outpatient hospitals (HOPD) increased to $45,000 (up approximately 48% from 2025) and for ambulatory surgical centers (ASC) to $42,373 (up approximately 58%) [6][12][17]. - Genio's wireless and external energy supply design avoids complications associated with wires, lowering long-term maintenance costs and repair risks [9][12]. - The selective stimulation design allows for precise control over the movement of the tongue, enhancing the effectiveness of the treatment [13]. CMS Reimbursement Changes - The reclassification of CPT 64568 into the new technology payment category APC 1580 significantly improves reimbursement levels, lowering economic barriers for healthcare providers to adopt Genio [14]. - The increased reimbursement aligns with the trend towards outpatient procedures, making Genio suitable for ASC environments, which are becoming more prevalent [15]. - The patient demographic for OSA overlaps significantly with Medicare beneficiaries, making robust Medicare reimbursement critical for HNS adoption [19]. Competitive Landscape - Nyxoah's primary competitor is Inspire Medical, which has established a dominant market position. However, Genio's unique technology and surgical process differentiate it from Inspire [20]. - Genio's single incision and wireless design make it more suitable for ASC settings, contrasting with Inspire's reliance on hospital resources due to its more complex implantation process [21][22]. - The external energy supply of Genio allows for future innovations and personalized treatments, creating a distinct market position compared to Inspire's implanted power source [23]. Industry Insights - The reimbursement increase reflects a broader trend in the HNS market, indicating a shift from CPAP reliance to more advanced surgical techniques for OSA treatment [24].