Nyxoah SA, a medical technology company developing solutions to treat obstructive sleep apnea (OSA), announced operating results for the second quarter and first half of 2023, emphasizing advances in its DREAM study. The study is an investigational device exemption trial designed to support the marketing authorization of the Genio neurostimulator system for the treatment of OSA in the United States.
During the quarter, Nyxoah presented 12-month efficacy data on the first 34 DREAM patients and safety data on all DREAM patients at SLEEP 2023, demonstrating a 65% apnea-hypopnea index responder rate, a 76% ODI responder rate, and safety in-line with expectations. These data are preliminary and not conclusive of the final DREAM success.
The company also filed the second module in the modular premarket approval (PMA) submission and accelerated US pre-commercialization efforts, focused on market access and commercial leadership.
“Being less than nine months away from the DREAM study readout, our attention continues to be on patient follow-up. We are highly encouraged by both the efficacy and safety data presented at SLEEP 2023. Our modular PMA filing is well underway, with the second module submitted during the quarter,” says Olivier Taelman, Nyxoah’s CEO, in a release. “We are building strong commercial expertise in the competitive German market. Our direct-to-consumer advertising, helpline, and referral networks have increased HGNS (hypoglossal nerve stimulation) penetration and give us confidence on entering new markets.”
Additionally, Nyxoah continued enrollment for the ACCCESS US investigational device exemption pivotal study to treat complete concentric collapse patients. Implant completion is expected in 2024.
