Nyxoah (NYXH) Oppenheimer 36th Annual Healthcare MedTech & Services Conference summary

Market opportunity and technology differentiation

• Obstructive sleep apnea represents a $10 billion market in the U.S., with significant under-penetration and only two active players following recent FDA approval for Genio.

• Genio offers a unique bilateral neuromodulation solution, with a minimally invasive, battery-free implant and a smart wearable, providing effective therapy even in supine sleep positions.

• The technology is MRI compatible, travel-friendly, and allows for remote software upgrades, ensuring patients always have access to the latest features without re-surgery.

• Clinical evidence from the DREAM pivotal study shows a 63.5% reduction in AHI and a 71% median reduction after 12 months, with strong safety and efficacy, especially in complex airway obstructions.

• Genio is commercially reimbursed in several international markets and is actively expanding in the U.S. and selectively in Asia.

Commercialization and market strategy

• U.S. launch focuses on 400 high-volume hypoglossal nerve implanting accounts, representing 70% of the market; 125 accounts were covered post-launch, with 119 trained and over 70 approvals in Q4.

• Over 50 accounts were actively doing business in Q4, generating $4.5 million in U.S. revenue and setting the stage for continued double-digit growth.

• The sales organization includes 40 sales reps and a total U.S. team of 60, supported by market access, marketing, and training teams, with strong interest and waiting lists among surgeons.

• The strategy targets CPAP-quitting patients and leverages referral relationships with sleep physicians, avoiding large-scale DTC spending.

• Internationally, the company achieved 22-23% market share in Germany three years post-launch and is expanding into the UAE and Singapore.

Competitive advantages and demand drivers

• Physicians value the new optionality Genio provides, with 15% of patients refusing battery-based devices, making Genio an attractive alternative.

• Clinical superiority is highlighted by efficacy in supine sleep and complex airway obstructions, with upcoming data expected to support label expansion.

• Patients appreciate the discreet, single-incision procedure, absence of battery replacements, and ongoing software upgrades.