Full data set demonstrates proximal hypoglossal nerve stimulation yields clinically significant and sustained improvements for patients with moderate to severe OSA.

Key takeaways:

The Annals of Internal Medicine published 12-month data from the OSPREY randomized controlled trial, evaluating the safety and efficacy of LivaNova’s aura6000 System.
Patients receiving pHGNS showed significant improvements in AHI, sleep quality, and patient-reported outcomes at seven and 13 months.
Following US FDA premarket approval of the aura6000 System earlier this year, LivaNova anticipates commercializing its OSA product independently in 2027.

The Annals of Internal Medicine has published a paper chronicling the full 12-month data set for LivaNova PLC’s OSPREY randomized controlled trial.

The researchers evaluated the safety and efficacy of proximal hypoglossal nerve stimulation (pHGNS) when delivered by LivaNova’s aura6000 System for the treatment of moderate to severe obstructive sleep apnea (OSA). The authors concluded that pHGNS for OSA yielded clinically significant improvements versus the control at month seven with sustained improvements through month 13 of OSPREY, corresponding with six and 12 months of therapy, respectively.

“Previous HGNS studies have largely been case series of highly selected OSA patients, leading to a deficiency in the evidence base,” says Atul Malhotra, MD, lead investigator for the study, professor of medicine at the University of California San Diego School of Medicine, and sleep medicine specialist at UC San Diego Health, in a release. “OSPREY was designed to overcome that challenge by including participants with diverse demographics, as well as a broad range of OSA severity to better represent patients who are commonly seen in clinical practice… For patients battling moderate to severe OSA, OSPREY’s aggregate data clearly demonstrate improvement in both objective OSA severity and associated factors such as daytime sleepiness and other pros.”

In the study, researchers explored pHGNS as a potential alternative for adult patients with OSA who are intolerant of CPAP. The therapy utilizes six electrodes placed on the proximal trunk of the hypoglossal nerve, offering broad access to the muscles controlling the airway and a wider set of titration options.

A total of 104 adults participated in OSPREY. The no stimulation-controlled 2:1 randomized study initiated therapy at month one (treatment) and month seven (control). An open-label extension was conducted following the month seven endpoint, with all participants receiving therapy until month 13. LivaNova previously announced 12-month, top-line data from the OSPREY trial in May 2025.

OSPREY data demonstrated:

There were improvements in the proportion of subjects achieving ≥25% ODI reduction at M7: 69% (treatment) vs 38% (control), yielding a reduction in median ODI from baseline (35 events per hour [e/hr]) to M7 (13 e/hr) with treatment.
The median AHI in the pHGNS treatment group was 34.3 e/hr at baseline and 11.6 e/hr at M7; the difference in median (95% confidence interval) AHI between the treatment and control groups at M7 was −18.9 (−27.0, −10.6) e/hr. By M13, outcomes improved in both groups; median AHI in the pHGNS treatment group was 11.0 e/hr with treatment and 20.9 e/hr in the control group (now active).
CGI-I response rate in the treatment group exceeded the control group at M7 (56% vs 9%) and increased to 59% at M13. The CGI-I scale is a seven-point clinician-rated tool used to assess a patient’s overall change in illness severity over time.
Pros included:
- ESS scores demonstrating improvement in treatment group at M7 (median score 10.0 to 6.0) beyond the minimal clinically importance difference (MCID) of 2, but not in control group (median score 9.0 to 9.0). By M13, both groups improved on therapy from baseline.
- For the FOSQ, there was an improvement from baseline to M7 in the treatment group (median score 15.8 to 17.8) meeting the MCID of 2, but not in the control group (median score 16.0 to 16.3). By M13, both groups improved on therapy from baseline to median scores of 18.5 (treatment) and 18.3 (control, now active).

Arousals from sleep significantly declined with pHGNS stimulation therapy. The treatment group at baseline had an arousal index of about 55/hr despite having a sleep efficiency of ≥85%, and at M13 arousals declined to 29/hr. Of note, respiratory arousals were essentially resolved while some non-respiratory arousals persisted.
No serious procedure-related adverse events were reported. Most treatment-emergent adverse events were mild or moderate in severity, and the most common events were headache, implant site pain, and difficulty swallowing.

“LivaNova’s pHGNS technology is designed to provide more complete control of the tongue and airway, enabling the ability to treat a wide range of challenging patients compared to previous HGNS pivotal studies, including patients with higher AHI, higher BMI, and complete concentric collapse, and delivers durable, holistic clinical responses. The results over time are quite compelling,” says Ahmet Tezel, PhD, chief innovation officer of LivaNova, in a release.

OSPREY baseline values of OSA severity and BMI were representative of the general OSA population, and the study did not exclude patients with complete concentric collapse (CCC). Response rates and AHI reductions with 12 months of pHGNS therapy for patients in OSPREY with predicted risk for CCC were consistent with the results for the full study population.

“OSA affects up to 1 billion people worldwide, yet the majority of patients remain undiagnosed and untreated,” says Lucile Blaise, global head of commercialization, OSA, at LivaNova, in a release. “With strong clinical results, a dedicated team, and a commitment to innovation, we are eager to make this treatment available to patients in need of an alternative therapy.”

LivaNova received premarket approval from the FDA for the aura6000 System in March. The company is currently preparing its next-generation OSA device for a PMA supplement application to the FDA, which is being designed for compatibility with magnetic resonance imaging (MRI), remote configuration management, and a rechargeable battery lasting up to 15 years. Pending a successful conclusion of the FDA’s review, the company anticipates commercializing its OSA product independently in 2027.