PMA Approval Progress
Nyxoah received an approvable letter from the FDA for the Genio system, confirming the application substantially meets the U.S. marketing requirements. The FDA has no further questions on the manufacturing validation, and the final on-site inspection is expected to be completed shortly.
U.S. Commercial Launch Preparations
Nyxoah has built a commercial team of 50 members in the U.S., ready to support the launch of Genio, with a strategy focused on high-volume hypoglossal nerve stimulation centers and building networks with sleep physicians.
Reimbursement and Pricing Strategy
Nyxoah plans to use the established CPT code 64568 for reimbursement, which is recognized for OSA indications, expecting pricing similar to competitors but differentiating through unique technology benefits.
Genio 2.1 Software Upgrade
The Genio 2.1 patient software upgrade has been launched, offering increased patient autonomy and comfort by allowing gradual stimulation increases and more personalized settings.
Middle East Market Entry
Nyxoah has successfully entered the Middle East market, with initial Genio implants conducted in Dubai and plans to expand to Kuwait and Saudi Arabia.