Dive Brief:
- Livanova said Monday a trial of its obstructive sleep apnea (OSA) implant met its primary safety and efficacy endpoints, positioning the company to seek approval once the analysis is complete.
- The randomized trial linked Livanova’s aura6000 to improvements on measures of OSA severity and blood oxygen after six months of treatment with the hypoglossal nerve stimulator. The hypoglossal nerve controls the tongue muscles.
- Leerink Partners analysts said the results were largely in line with outcomes seen in a trial of Inspire Medical Systems’ rival device. The analysts see ways that Livanova could differentiate its device but said the company “may have a difficult time breaking into the sleep apnea market.”
Dive Insight:
Livanova stopped enrollment in the trial ahead of schedule in March after finding the study had a greater than 97.5% chance of meeting its primary endpoint. The company confirmed the success of the trial this week. More patients in the treatment arm than the sham cohort had a 50% or greater improvement in OSA severity after seven months of follow-up, causing the trial to hit its primary efficacy endpoint.
The data release lacked details of the response rates in the treatment and sham cohorts. Livanova reported a median 66.2% reduction on the OSA severity scale and a 63.3% decline on a measure of how often a person’s blood oxygen level drops during sleep.
Leerink analysts said in a note to investors that the data “look good,” adding that clinical measures of efficacy were generally similar with those seen from competitor systems.
Needham analysts said the data should support Food and Drug Administration approval. Livanova plans to file for premarket approval once it has completed analyzing data from the seven-month follow-up visits.
If approved, aura6000 will compete with Inspire’s OSA implant and, potentially, Nyxoah’s near-approval Genio device. The devices are mask-free alternatives to the continuous positive airway pressure machines traditionally used to treat OSA. Once implanted, aura6000 and the rival devices stimulate muscles to stop the patient’s tongue from blocking the airway.
Livanova’s top-line data leave unanswered questions about how aura6000 compares to its competitors. On an earnings call in October, Livanova CEO Vladimir Makatsaria said the upcoming 13-month data will be the most important. Previous research suggests clinical outcomes improve between 7 and 13 months of follow-up, the CEO said. The company expects to have the follow-up data in the first half of 2025.
Makatsaria is still considering how to commercialize aura6000, telling investors that Livanova may take the device to market itself, find a partner or pursue “other options.”
Leerink analysts said the data will shape commercialization.
“We expect there may be incremental physician interest in [Livanova’s] device as additional clinical data becomes available,” the analysts said. “At present, we continue to expect [Livanova] may have a difficult time breaking into the sleep apnea market based on limited physician mindshare and potential drawbacks to patient experience.”
Outcomes in patients with complete concentric collapse are of particular interest. Patients with the form of airway collapse are ineligible for treatment with Inspire’s device, but Livanova included them in its trial. Leerink analysts said positive data in the subpopulation could “represent a potentially important point of differentiation and competitive advantage” for Livanova.