LivaNova: patient cohort preliminary results of Recover study did not meet PE

LivaNova announced the preliminary results for the unipolar patient cohort of the RECOVER clinical study, assessing the use of VNS Therapy in treatment-resistant depression. The study did not meet its primary endpoint PE for the unipolar cohort; however, statistical significance was achieved in select secondary endpoints. The PE measured the difference between active and sham VNS Therapy on the rate of Montgomery-Asberg Depression Rating Scale MADRS response for the unipolar patient cohort with a predetermined p-value of pless than0.023. Over the course of 12 months, the active treatment arm demonstrated statistically significant and clinically meaningful improvement from the treatment arm’s baseline. Due to a strong response in the sham group, which was unforeseen in the study design, statistical separation between the treatment and sham arms for the PE was not achieved by the end of the study. Despite this, the totality of data supports a meaningful treatment effect for those who received active VNS Therapy particularly given that the RECOVER unipolar patient population has a significant unmet need after having failed numerous other treatment modalities. “We would like to thank the patients and physicians who participated in RECOVER to date, as well as the U.S. Centers for Medicare and Medicaid Services, who we partnered with to design this study,” said Vladimir Makatsaria, Chief Executive Officer of LivaNova. “Despite not achieving statistical significance for the primary endpoint for the unipolar cohort in the RECOVER study, the effect of active VNS Therapy was within our expectations and resulted in clinically meaningful benefits in select secondary endpoints. We are conducting an in-depth analysis of the data with key stakeholders and will determine the path forward in the coming weeks.” The Company expects to publish the unipolar cohort data, including details on the PE and secondary endpoints, in peer-reviewed journals in the fourth quarter of 2024. Importantly, no safety issues were reported.