LivaNova announces OSPREY clinical study meets safety/efficacy endpoints

LivaNova (LIVN) “announced that it met the primary endpoints for its OSPREY randomized controlled trial, Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Nerve Stimulation. Together with its safety endpoints, the RCT achieved statistical significance of its primary endpoint responder rates1,2 between the treatment arm and the sham arm for the LivaNova aura6000(TM) System. The aura6000 is an implantable hypoglossal neurostimulator intended to treat adult patients with moderate to severe obstructive sleep apnea. In the OSPREY study, apnea-hypopnea index and oxygen desaturation index (ODI) reductions are analyzed as part of the study’s secondary endpoints. Comparing median values from baseline to six months with therapy (assessed at the seven-month follow-up visit), OSPREY subjects in the device stimulation group experienced significant reductions in these endpoints as follows: AHI reduced by 66.2% when the median at baseline of 34.3 is compared to the median of 11.6 at six months. ODI reduced by 63.3% when the median at baseline of 34.9 is compared to the median of 12.8 at six months. Once the six-month results analysis is completed, LivaNova will submit the OSPREY clinical data to the U.S. Food and Drug Administration as part of its premarket approval submission for the aura6000 System.”