LivaNova PLC (Nasdaq: LIVN), a leading medical technology company, today announced that its OSPREY randomized controlled trial (RCT) met its primary safety and efficacy endpoints. The trial, which evaluated the LivaNova aura6000™ System for treating obstructive sleep apnea (OSA) using targeted hypoglossal nerve stimulation, achieved statistical significance in responder rates between the treatment group and the sham group. The aura6000 is an implantable hypoglossal neurostimulator designed to treat adults with moderate to severe OSA.
The OSPREY study demonstrated significant improvements in secondary endpoints, with patients in the device stimulation group showing substantial reductions in both the Apnea-Hypopnea Index (AHI) and Oxygen Desaturation Index (ODI) after six months of therapy. Key findings include:
- AHI decreased by 66.2%, from a baseline median of 34.3 to 11.6 at six months.
- ODI dropped by 63.3%, from a baseline median of 34.9 to 12.8 at six months.
Following the completion of the six-month analysis, LivaNova plans to submit these results to the U.S. Food and Drug Administration (FDA) as part of its premarket approval application for the aura6000 System.
“These study results reinforce our belief in the potential of targeted hypoglossal nerve stimulation as a compelling alternative for patients with obstructive sleep apnea,” said Vladimir Makatsaria, CEO of LivaNova. “The significant reductions in AHI and ODI after just six months of therapy provide strong evidence of the technology’s long-term benefits. We look forward to evaluating the complete data set as patients complete 12 months of treatment.”
The OSPREY study, which will continue to collect long-term data, is expected to provide 12-month follow-up results in the first half of 2025.
Lead investigator Dr. Atul Malhotra, Professor of Medicine at the University of California San Diego and sleep medicine specialist at UC San Diego Health, commented, “In addition to meeting the primary safety and efficacy outcomes, the reductions in AHI and ODI after just six months show a significant clinical impact for patients suffering from OSA.”
Notably, there were no serious device-related or procedure-related adverse events reported during the trial’s primary endpoint visits.
About OSPREY
The OSPREY study is a multi-center, randomized controlled trial evaluating the safety and efficacy of the aura6000™ Hypoglossal Nerve Stimulator System in patients with moderate to severe OSA who have failed or are unwilling to use continuous positive airway pressure (CPAP) treatment. The device is investigational and is limited to use in clinical trials under U.S. law.
About LivaNova
LivaNova PLC is a global medical technology company with nearly five decades of experience in developing life-changing solutions for patients with neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 people and operates in over 100 countries worldwide.
