Results published in two articles in Brain Stimulation

LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, today announced that the journal Brain Stimulation has published two pivotal articles chronicling the unipolar cohort data set for the RECOVER clinical study. The researchers evaluated the safety and efficacy of LivaNova's VNS Therapy System and its effectiveness on quality of life and daily function in this population of patients with treatment-resistant unipolar depression. Overall, the articles concluded that active VNS Therapy, as compared with a no-stimulation control (or sham VNS Therapy), safely and effectively demonstrated clinically meaningful therapeutic effects on depressive symptoms and positive effects on quality of life and daily function. These findings support the use of VNS Therapy to deliver vagus nerve stimulation (VNS) in treatment-resistant depression (TRD) patients.

A total of 493 adults with at least four documented unsuccessful attempts with antidepressant treatments participated in the unipolar cohort of the RECOVER study. At baseline, unipolar patients in the study failed more than 13 antidepressant treatments (on average) – this included, for the majority, one or more interventional therapies (e.g., transcranial magnetic stimulation, electroconvulsive therapy, or esketamine). While the RECOVER study did not meet the primary endpoint due to a strong and unforeseen response in the sham group, the active treatment arm demonstrated statistically significant and clinically meaningful improvement from the treatment arm's baseline. Further, the RECOVER study demonstrated statistically significant and clinically meaningful benefits in select secondary endpoints for this cohort. Based upon these findings and the positive effects for those who received VNS Therapy, the Company conducted additional in-depth data analyses and plans to submit three additional critical manuscripts to report on the outcomes.