LivaNova PLC (Nasdaq: LIVN) has announced positive results from its OSPREY randomized controlled trial (RCT) evaluating the aura6000 System for treating moderate to severe obstructive sleep apnea (OSA). The study met its primary safety and efficacy endpoints, demonstrating statistically significant improvements in key respiratory indices.
The OSPREY trial, formally titled "Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation," assessed the aura6000 System, an implantable hypoglossal neurostimulator designed for adult patients with OSA. The trial's success paves the way for a potential new treatment option for individuals who have failed or are unwilling to use positive airway pressure (PAP) therapies.
Significant Reductions in AHI and ODI
Key secondary endpoints from the OSPREY study revealed substantial reductions in both the apnea-hypopnea index (AHI) and the oxygen desaturation index (ODI) after six months of therapy. Specifically, the median AHI decreased by 66.2%, from 34.3 at baseline to 11.6 at six months. Similarly, the median ODI decreased by 63.3%, from 34.9 at baseline to 12.8 at six months. These results indicate a marked improvement in sleep quality and respiratory function among patients treated with the aura6000 System.
Safety Profile and Future Directions
Importantly, the OSPREY trial reported no serious adverse device-related or procedure-related events throughout the primary endpoint visits. This favorable safety profile, coupled with the significant efficacy outcomes, positions the aura6000 System as a promising alternative for OSA management.
LivaNova plans to submit the OSPREY clinical data to the U.S. Food and Drug Administration (FDA) as part of its premarket approval submission for the aura6000 System. The company anticipates that 12-month data from the trial will be available in the first half of 2025.
Expert Commentary
"In addition to meeting the primary safety and efficacy outcomes, the reductions in AHI and ODI after only six months of therapy demonstrate a significant clinical impact for the patients," said Dr. Atul Malhotra, lead investigator for the study, professor of medicine at University of California San Diego School of Medicine and sleep medicine specialist at University of California San Diego Health.
Market Opportunity
Obstructive sleep apnea affects an estimated 30 million Americans, many of whom struggle with adherence to continuous positive airway pressure (CPAP) therapy, the current standard of care. An implantable alternative like the aura6000 System could address this unmet need and capture a significant share of the expanding sleep apnea device market.
"The study results reinforce our belief that targeted hypoglossal nerve stimulation provides a compelling alternative for patients with obstructive sleep apnea. The significant reductions in AHI and ODI achieved after only six months of therapy gives us strong evidence of this technology’s potential at 12 months and beyond," said Vladimir Makatsaria, Chief Executive Officer of LivaNova.
