Nyxoah SA has announced that its DREAM U.S. pivotal study for the Genio system, a novel treatment for Obstructive Sleep Apnea (OSA), has successfully achieved its co-primary endpoints. This milestone brings the company closer to potential FDA approval, which could come as early as the end of 2024.
The DREAM study demonstrated impressive efficacy results on an intent-to-treat (ITT) basis, with a median Apnea-Hypopnea Index (AHI) reduction of 70.8%. The 12-month AHI responder rate, measured according to the Sher criteria, reached 63.5% (p=0.002), while the 12-month Oxygen Desaturation Index (ODI) responder rate was 71.3% (p<0.001).
Genio System: A Differentiated Approach to OSA Treatment
The Genio system represents a significant advancement in hypoglossal neurostimulation (HGNS) therapy for OSA. Unlike competing technologies, Nyxoah's device has demonstrated strong efficacy in both supine and non-supine sleep positions, addressing a critical limitation of current treatments.
"The DREAM U.S. study achieving its primary endpoints is a pivotal milestone for Nyxoah and further differentiates Genio as the only HGNS therapy to demonstrate strong efficacy in supine and non-supine OSA," said Olivier Taelman, Nyxoah Chief Executive Officer. "With the DREAM data in hand, our U.S. launch preparations are focused on attracting commercial talent to set us up for success when we introduce Genio."
The Genio system is designed as a patient-centered, leadless, and battery-free neurostimulation therapy for OSA, which affects millions worldwide and is associated with increased mortality risk and cardiovascular comorbidities.
Regulatory Progress and Commercial Strategy
Nyxoah is preparing to submit the fourth and final module of its Premarket Approval (PMA) application to the FDA this quarter. The company has already received CE Mark approval in Europe in 2019, with expanded therapeutic indications following the positive outcomes of the BETTER SLEEP study to include Complete Concentric Collapse (CCC) patients, a population currently contraindicated in competitors' therapies.
To strengthen its clinical leadership, Nyxoah recently appointed Dr. Maurits S. Boon, MD as Chief Medical Officer. The company has also advanced its patient access strategy through a partnership with the American Association of Otolaryngology – Head & Neck Surgery Foundation (AAO-HNSF).
Financial Performance
Nyxoah reported revenue of €1.2 million for the first quarter of 2024, representing a 170% increase compared to €441,000 in the first quarter of 2023. This growth was primarily driven by the commercialization of the Genio system in Germany.
The company achieved a gross profit of €0.8 million, reflecting a gross margin of 62.7%, an improvement from 60.3% in the same period last year. Research and development expenses increased to €7.2 million from €6.2 million in Q1 2023, reflecting continued investment in product development.
Total operating loss for the quarter was €12.2 million, compared to €11.4 million in Q1 2023, attributed to accelerated R&D spending and ongoing commercial and clinical activities. As of March 31, 2024, Nyxoah maintained a strong financial position with cash and financial assets totaling €44.3 million, though this represents a decrease from €57.7 million at the end of 2023, with a monthly cash burn rate of approximately €4.5 million.
Market Potential and Future Outlook
OSA is the world's most common sleep-disordered breathing condition, affecting an estimated 936 million adults globally aged 30-69, according to recent epidemiological data. The condition is associated with serious health consequences, including increased risk of hypertension, heart failure, stroke, and type 2 diabetes.
The positive DREAM study results position Nyxoah to potentially capture significant market share in the growing neurostimulation segment of OSA treatment. The company's patient-centric approach, with a leadless and battery-free design, offers advantages over existing therapies that require more invasive implantation procedures.
With continued European commercial traction and promising clinical data, Nyxoah is preparing for a potential U.S. market entry following FDA approval. The company's focus on building commercial capabilities and expanding patient access strategies suggests confidence in the Genio system's potential to address the substantial unmet need in OSA treatment.
As Nyxoah advances toward potential FDA approval, the medical community will be watching closely to see how this innovative technology might reshape the treatment landscape for patients suffering from obstructive sleep apnea.
