By the late afternoon, LIVN shares were down more than 12% to $52.73 apiece on the news. MassDevice‘s MedTech 100 Index was up slightly.
Symmetry VNS Therapy did not meet its primary endpoint in the unipolar cohort in the RECOVER study. However, LivaNova said it achieved statistical significance in select secondary endpoints.
The primary endpoint measured the difference between active and sham VNS Therapy on the rate of Montgomery–Åsberg Depression Rating Scale (MADRS) response for the unipolar patient cohort. Over 12 months, the active treatment arm demonstrated statistically significant and clinically meaningful improvement from the treatment arm’s baseline.
LivaNova said the study recorded an unforeseen strong response in its sham group. That led to the failure to achieve statistical separation between arms for the primary endpoint, the company said. The company says the totality of the data supports a meaningful treatment effect from VNS Therapy, though.
According to LivaNova, its therapy addresses a significant unmet need in patients who failed numerous other treatment modalities. The study also recorded no safety issues.
RECOVER principal investigator Dr. Charles R. Conway, director of the Washington University in St. Louis Resistant Mood Disorders Center, called the results encouraging despite falling short of the primary endpoint. LivaNova expects to publish its unipolar cohort data in the fourth quarter. The bipolar cohort continues in the study as well.
“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, LivaNova CEO. “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.”
