iosebi meladze/iStock via Getty Images Shares of LivaNova ( NASDAQ: LIVN ) fell 11% in late morning trading Thursday after the company reported that the unipolar patient cohort of its RECOVER study for its VNS Therapy product for treatment-resistant depression failed to meet its primary endpoint. The company said that while the study for the cohort group didn’t meet the primary endpoint, it did achieve select secondary endpoints. LivaNova plans to conduct an analysis of the data to determine a path forward in the coming weeks , according to a company statement.
Researchers plan to publish the unipolar cohort data in peer-reviewed journals in Q4. The bipolar patient cohort of the RECOVER study is ongoing. LivaNova said it will continue to discuss coverage of the therapy for treatment-resistant depression with the Centers for Medicare and Medicaid Services, or CMS.
The FDA approved VNS Therapy for the treatment of depression in 2005. The company initiated the RECOVER study in 2019 as part of a Coverage with Evidence Development Framework for the CMS National Coverage Determination process. More on LivaNova PLC LivaNova: Focus Is Paying Off LivaNova PLC (LIVN) Q1 2024 Earnings Call Transcript LivaNova PLC 2024 Q1 - Results - Earnings Call Presentation LivaNova beats top-line and bottom-line estimates; raises FY24 outlook LivaNova PLC Q1 2024 Earnings Preview.
