LivaNova's PolySync Algorithm Increases Apnea-Hypopnea Index Response Rate to 84.5%

LivaNova announced new data showing that use of its PolySync programming algorithm increased the cumulative apnea-hypopnea index response rate to 84.5% in patients with moderate to severe Obstructive Sleep Apnea when treated with proximal hypoglossal nerve stimulation. The findings were presented at SLEEP 2026, the 40th annual meeting of the Associated Professional Sleep Societies, by lead author Alan Schwartz, M.D., adjunct professor of otorhinolaryngology in the Perelman School of Medicine at the University of Pennsylvania and research professor of otolaryngology for Vanderbilt Health.The results build on LivaNova's previously reported outcomes from the OSPREY randomized controlled trial, which reported a 65% responder rate in the treatment arm after 12 months of pHGNS therapy delivered by the Company's aura6000 System. In the PolySync substudy, patients who did not meet responder criteria after one year of individual-contact stimulation in OSPREY underwent reprogramming using simultaneous-contact stimulation. This approach converted the majority of these patients into responders, significantly improving both AHI and oxygen desaturation index outcomes and increasing the cumulative response rate to 84.5%. LivaNova previously announced that PolySync will be available with its commercial pHGNS product, enabling the integration of advanced, patient-specific titration at the onset of therapy. The PolySync findings extend the strong clinical foundation established by LivaNova's OSPREY and THN3 RCTs, the first RCTs in hypoglossal nerve stimulation. As previously reported, OSPREY met its primary safety and efficacy endpoints at six months, demonstrating significant reductions in AHI and ODI, with continued improvements through 12 months of therapy. The full dataset, published in Annals of Internal Medicine, confirmed clinically meaningful and sustained improvements across both objective measures and patient-reported outcomes, including daytime sleepiness and functional quality of life. PolySync builds on LivaNova's differentiated pHGNS platform, which utilizes a six-contact electrode positioned on the proximal hypoglossal nerve, prior to any nerve branching, to enable broader access to airway muscles and flexible therapy optimization. By enabling simultaneous-contact stimulation, PolySync expands the variety and number of possible stimulation fields, allowing for broader and more flexible activation of lingual muscles and improved treatment responsiveness across a heterogeneous patient population.PolySync programming was well tolerated, with no serious treatment-emergent adverse events and no stimulation- or device-related adverse events reported in the substudy.