Nyxoah's ACCCESS Trial Meets Co-Primary Endpoints for Genio in Complex Sleep Apnea Patients
核心洞察
Nyxoah (搜索)'s U.S. pivotal ACCCESS study met its co-primary efficacy and safety endpoints in patients with obstructive sleep apnea (搜索) and complete concentric collapse of the soft palate.
The Genio (搜索) neurostimulation system achieved a 77.2% Apnea-Hypopnea Index responder rate and an 87.7% Oxygen Desaturation Index responder rate at 12 months.
No serious device-related adverse events were observed, supporting a favorable safety profile for the therapy.
Nyxoah (搜索) has reported that its American pivotal ACCCESS study in patients with obstructive sleep apnea (搜索) (OSA) and complete concentric collapse (CCC) of the soft palate met its co-primary efficacy and safety endpoints. The Genio (搜索) neurostimulation system achieved a 77.2% Apnea-Hypopnea Index (AHI) responder rate and an 87.7% Oxygen Desaturation Index (ODI) responder rate at 12 months, with no serious device-related adverse events observed.
The ACCCESS results are intended to support expansion of Genio (搜索)'s U.S. indication to this underserved patient group, which is currently contraindicated for unilateral hypoglossal nerve stimulation. Nyxoah (搜索) is preparing a supplement to its premarket approval authorization under the FDA's Breakthrough Device program, a move that could enhance its competitive position in the U.S. sleep apnea market by offering physicians a new treatment option for CCC patients.
Clinical Significance for an Underserved Population
Patients with complete concentric collapse of the soft palate represent a distinct and historically difficult-to-treat subgroup within obstructive sleep apnea (搜索). According to the source materials, this patient population is currently contraindicated for unilateral hypoglossal nerve stimulation, leaving a significant unmet need for alternative therapeutic approaches. The ACCCESS trial directly addresses this gap by evaluating the Genio (搜索) system, a bilateral hypoglossal nerve stimulation therapy, in precisely this group.
The co-primary efficacy endpoints demonstrated robust treatment response. The 77.2% AHI responder rate and 87.7% ODI responder rate at 12 months indicate meaningful reductions in both apnea-hypopnea events and oxygen desaturation episodes, two key measures of sleep apnea severity and its physiological burden.
Safety Profile
The safety findings from the ACCCESS study are notable, with no serious device-related adverse events observed over the 12-month follow-up period. This favorable safety signal is an important consideration for a patient population that has limited approved treatment options.
Regulatory Pathway and Competitive Positioning
Nyxoah (搜索) is advancing the ACCCESS data through the FDA's Breakthrough Device program by preparing a supplement to its premarket approval authorization. If successful, this regulatory step would expand Genio (搜索)'s U.S. indication to include CCC patients, potentially strengthening Nyxoah's competitive position in the U.S. sleep apnea market by providing physicians with a new treatment option for a group currently without an approved neurostimulation therapy.
Complementary Real-World Evidence: The BREATHE Study
In parallel, Nyxoah (搜索) has announced the first patient implanted in BREATHE, the company's U.S. post-approval study of the Genio (搜索) system. BREATHE is a multicenter, prospective, single-arm post-approval study designed to assess the long-term safety and effectiveness of Genio in adults with moderate to severe OSA. Up to 229 patients will be implanted at up to 25 clinical centers across the United States and followed for up to five years after implantation.
The co-primary effectiveness endpoints of BREATHE are the AHI and ODI responder rates at 12 months, while safety endpoints assess device- and procedure-related serious adverse events at 12 months and annually thereafter. The first implant was performed by Rolando Molina, MD, otolaryngologist at South Florida ENT Associates, with Edward Mezerhane, MD, FAASM, FACP, DABOM, CPI, sleep medicine physician at PharmaDev Clinical Research Institute (Miami, Florida), serving as the BREATHE Site Principal Investigator.
"As an otolaryngologist dedicated to the treatment of sleep-disordered breathing, I have seen firsthand the significant impact obstructive sleep apnea (搜索) has on patients' health and quality of life. The BREATHE study represents an exciting milestone in the evolution of sleep surgery and neurostimulation therapy," said Rolando Molina, MD, implanting surgeon.
BREATHE is designed to generate real-world evidence on how Genio (搜索) performs in routine clinical practice across a broad set of U.S. centers, bringing together sleep medicine physicians and ENT surgeons, and will contribute to the ongoing evaluation of long-term patient outcomes.