LivaNova
(Nasdaq: LIVN)
today announced positive outcomes from a study of its nerve stimulator system for treating sleep apnea.
The company said its OSPREY clinical trial achieved a positive predictive outcome and concluded enrollment earlier than anticipated. This means the company projects a greater than 97.5% probability that OSPREY successfully meets its primary endpoint.
London-based LivaNova’s OSPREY trial evaluates its aura6000 hypoglossal nerve stimulator system. It pits the system against a no-stimulation control group in subjects with moderate to severe obstructive sleep apnea (OSA). These patients failed with or are unwilling to use positive airway pressure (PAP) treatment.
Following the milestone, LivaNova said investigators plan to continue long-term follow-ups through the primary endpoint and beyond.
The trial its primary efficacy endpoint as the demonstration that the apnea-hypopnea index (AHI) responder rate of subjects with device stimulation activated is statistically significantly higher than the rate of subjects without stimulation after seven months of follow-up. OSPREY defines response as at least 50% improvement from the baseline AHI, leading to an AHI value below 20.
Once the full cohort completes seven-month follow-up, LivaNova plans to submit the final clinical module to the FDA. If eventually approved, the nerve stimulation system could provide competition to Inspire Medical’s own similar offering. Both represent alternatives to PAP therapy, a market previously dominated by Philips before its major recall woes, with ResMed another big name in PAP therapy.
“We are pleased to have achieved this positive milestone for the OSPREY study,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “In accordance with the study protocol, once the last patient implanted completes their final follow-up visit, we will conduct the final analysis for the study. Until then, we will continue to actively work with the clinical sites to manage the study patients.”