Livanova announced that its clinical trial for the aura6000, an implantable hypoglossal nerve stimulator for treating obstructive sleep apnea (OSA), has met its primary safety and efficacy endpoints. The randomized trial demonstrated significant improvements in measures of OSA severity and blood oxygen levels after six months of treatment, positioning the company to seek FDA approval.
The OSPREY trial's success was determined by a greater proportion of patients in the treatment arm achieving a 50% or greater reduction in OSA severity compared to the sham cohort after seven months of follow-up. The data revealed a median 66.2% reduction on the OSA severity scale and a 63.3% decline in the frequency of blood oxygen level drops during sleep.
Device Details and Market Competition
The aura6000 device, upon implantation, stimulates muscles to prevent the tongue from obstructing the airway during sleep, offering a mask-free alternative to traditional continuous positive airway pressure (CPAP) machines. If approved, aura6000 will compete with Inspire Medical Systems’ OSA implant and potentially Nyxoah’s Genio device.
Analyst Perspectives
Leerink Partners analysts noted that the results align with those observed in trials of Inspire Medical Systems’ device. While acknowledging the positive data, they anticipate potential challenges for Livanova in penetrating the sleep apnea market due to limited physician awareness and potential drawbacks in patient experience.
Needham analysts believe the data should support FDA approval. Livanova anticipates completing the analysis of data from the seven-month follow-up visits soon, after which they plan to file for premarket approval.
Future Data and Commercialization Strategy
Livanova CEO Vladimir Makatsaria highlighted the importance of the upcoming 13-month data, expected in the first half of 2025, noting that previous research indicates clinical outcomes may improve between 7 and 13 months of follow-up. Makatsaria is evaluating various commercialization strategies, including self-marketing, partnering, or exploring other options.
Potential Differentiation
Notably, Livanova’s trial included patients with complete concentric collapse, a subgroup ineligible for Inspire’s device. Positive data in this subpopulation could provide a competitive advantage for Livanova, according to Leerink analysts.
