LivaNova misses primary endpoint in depression trial

 Primary endpoint did not achieve statistical significance in unipolar patient cohort

Statistically significant and clinically meaningful benefits seen in select secondary endpoints; no safety concerns identified

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.

“I am encouraged by the clinically meaningful outcomes for the RECOVER unipolar patient population that is markedly treatment resistant,” said Dr. Charles R. Conway, Director of the Washington University in St. Louis Resistant Mood Disorders Center and Principal Investigator for RECOVER. “As we have previously published, the unipolar patients who entered the RECOVER study were of a greater severity than we had anticipated in the study design and have very few treatment options remaining. We now have a large body of data to evaluate, and I look forward to better understanding it in totality.”

The bipolar patient cohort continues for RECOVER and LivaNova will continue its discussions with the U.S. Centers for Medicare and Medicaid Services (CMS) regarding reconsideration of coverage for VNS Therapy for treatment-resistant depression.

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