SHERIDAN, WYOMING – May 9, 2025 – LivaNova PLC, a leading global medical technology company, has announced 12-month top-line data from its OSPREY clinical trial. The study demonstrates promising results for the aura6000™ System, an investigational device designed to treat moderate to severe obstructive sleep apnea (OSA). The data highlights sustained improvements in key health metrics, positioning the aura6000™ as a potential breakthrough in OSA management.
Strong Results from 12-month OSPREY Data
The OSPREY trial's 12-month data shows significant improvements for patients receiving the aura6000™ System, demonstrating the effectiveness of proximal hypoglossal nerve stimulation (p-HGNS) in managing OSA. The results confirm the system’s potential as a long-term solution for patients with moderate to severe cases who have previously struggled with conventional treatments.
Key highlights from the study include:
- 65% responder rate: Defined as patients achieving at least a 50% improvement in their apnea-hypopnea index (AHI) and an AHI value below 20.
- 68% reduction in median AHI: From a baseline median of 34.3 to 11.0 at 12 months.
- 68% reduction in median oxygen desaturation index (ODI): From a baseline of 34.9 to 11.1 at 12 months.
The significant reduction in AHI and ODI demonstrates the durable effects of the treatment. These improvements are crucial for OSA patients, as they correlate with better sleep quality, reduced daytime sleepiness, and overall functional improvement.
Positive Impact on Patient-Reported Outcomes
In addition to the clinical outcomes, the OSPREY study also included patient-reported outcomes that further highlight the benefits of the aura6000™ System. After 12 months of treatment, patients showed meaningful improvements in both the Epworth Sleepiness Scale (ESS) and Functional Outcomes of Sleep Questionnaire (FOSQ). These measures assess daytime sleepiness and the impact of fatigue on daily activities, respectively.
“OSPREY is the first major multi-center randomized, controlled pivotal trial of hypoglossal nerve stimulation,” said Dr. Atul Malhotra, lead investigator for the study. “We observed a rapid onset of therapy, with continued improvement over time. By 12 months, 65% of patients had responded to treatment, demonstrating its effectiveness as a long-term solution.”
Data Reinforces Aura6000™ System’s Efficacy for a Broad Range of OSA Patients
The OSPREY trial included a diverse group of patients, reflecting a broad spectrum of OSA severity and body mass index (BMI), with a specific focus on those at higher risk for complete concentric collapse (CCC), a severe form of airway obstruction. Despite these increased risks, the 12-month data indicates that the aura6000™ System remains effective, further validating its potential as a treatment option for a large, underserved patient population.
Ahmet Tezel, Ph.D., Chief Innovation Officer at LivaNova, commented, “The OSPREY 12-month results further validate the potential of this therapy as a treatment alternative for the large and growing OSA population. With the strength of our clinical data, expertise of our neuromodulation team, and the strategic growth opportunity ahead, we are eager to bring this innovation to patients.”
Moving Toward FDA Approval and Market Availability
LivaNova recently submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for the aura6000™ System, including the 12-month data from the OSPREY trial. The company plans to share the full 12-month dataset with the FDA during its review process, marking a key step toward potential approval and market availability.
“OSPREY data shows sustained improvement for patients with OSA, including those with severe cases and high BMI,” said Dr. Tezel. “We are excited about the opportunities ahead as we continue our efforts to bring this transformative technology to patients.”
A Growing Opportunity for OSA Treatment
The OSPREY data reinforces the need for innovative solutions in the treatment of obstructive sleep apnea, a condition affecting millions worldwide. As OSA continues to be a leading cause of cardiovascular and metabolic disorders, therapies like the aura6000™ System represent a promising advancement in patient care. The success of the OSPREY trial underscores the potential of neurostimulation therapies to improve lives and address a significant unmet medical need.
For more information about LivaNova and its ongoing clinical studies, visit www.livanova.com.