LivaNova PLC

“PolySync™ programming algorithm increased the cumulative apnea-hypopnea index (AHI) response rate to 84.5% in patients with moderate to severe Obstructive Sleep Apnea (OSA) when treated with proximal…”

“the OSPREY randomized controlled trial (RCT), which reported a 65% responder rate in the treatment arm after 12 months of pHGNS therapy delivered by the Company’s aura6000™ System.”

“OSPREY met its primary safety and efficacy endpoints at six months”

“continued improvements through 12 months of therapy”

“The full dataset, published in Annals of Internal Medicine”

“PolySync programming was well tolerated, with no serious treatment-emergent adverse events and no stimulation- or device-related adverse events reported in the substudy.”

“LivaNova is continuing to prepare its next-generation OSA device for a PMA supplement application to the FDA in the second half of 2026.”

“Building upon the FDA premarket approval received in March for aura6000”