LONDON - LivaNova PLC (NASDAQ:LIVN), a leader in medical technology, has shared preliminary findings from its RECOVER clinical trial, which evaluated the effectiveness of its VNS Therapy™ in patients with treatment-resistant depression. The study did not meet its primary endpoint for the unipolar depression cohort, but showed significant benefits in certain secondary measures.
The primary endpoint was to observe a statistical difference in response rates using the Montgomery-Åsberg Depression Rating Scale (MADRS) between the active VNS Therapy group and a sham group over a 12-month period. While the active treatment group saw a significant improvement from their baseline, the strong response in the sham group prevented a clear statistical distinction for the primary endpoint.
Despite the primary endpoint result, LivaNova CEO Vladimir Makatsaria stated that the active VNS Therapy showed clinically meaningful benefits in select secondary endpoints. The company plans to conduct a thorough analysis of the data and decide on the next steps in the near future.
Dr. Charles R. Conway, Director of the Washington University in St. Louis Resistant Mood Disorders Center and Principal Investigator for RECOVER, expressed optimism about the outcomes for the severely treatment-resistant unipolar patient population. The study's data is expected to be published in peer-reviewed journals in the fourth quarter of 2024.
The RECOVER study, which began in September 2019, is a large randomized controlled trial assessing VNS Therapy as an adjunctive treatment for depression. The therapy has been approved for this use since 2001 in Europe and 2005 in the United States. The bipolar patient cohort of the study continues, and discussions with the U.S. Centers for Medicare and Medicaid Services (CMS) about coverage for VNS Therapy are ongoing.
No safety concerns were identified in the study, and the VNS Therapy System, Symmetry™, has been known to cause side effects such as hoarseness, shortness of breath, sore throat, and coughing, which typically decrease over time.
This report is based on a press release statement from LivaNova PLC.
In other recent news, LivaNova, a global medical technology company, has reported a robust financial performance for the first quarter of 2024. The company's revenue surged by 12% year-over-year, primarily driven by strong sales in the cardiopulmonary and Neuromodulation segments. The Essenz heart-lung machine significantly contributed to the cardiopulmonary segment's performance.
Mizuho Securities has raised its stock price target for LivaNova to $80 from $75, maintaining a Buy rating. This adjustment comes after the company's first-quarter performance exceeded expectations, especially due to strong sales in its cardiopulmonary division. The company's adjusted operating margin also surpassed projections, recording 18% against Mizuho's estimate of 13%.
LivaNova has updated its full-year 2024 guidance, now anticipating a top-line constant currency growth of 8-9% year-over-year, an increase from the previous forecast of 6-7%. The company also expects an adjusted earnings per share in the range of $3.05 to $3.15, up from the earlier estimate of $2.95 to $3.05. These recent developments reflect the company's confidence in its trajectory and continued growth.
InvestingPro Insights
As LivaNova PLC (NASDAQ:LIVN) navigates the outcomes of its RECOVER clinical trial, investors and stakeholders are closely monitoring the company's financial health and market performance. According to InvestingPro data, LivaNova boasts a market capitalization of $3.25 billion. In terms of profitability, the company is trading at a forward P/E ratio of 27.19, reflecting investor expectations of earnings growth despite the company not being profitable over the last twelve months as of Q1 2024.
On the growth front, LivaNova has reported a revenue increase of 13.4% over the last twelve months, indicating a solid top-line expansion. Moreover, the company's gross profit margin stands at a robust 68.21%, suggesting effective cost management relative to its revenues. With an EBITDA growth of 60.77% in the same period, LivaNova is demonstrating significant operational efficiency improvements.
InvestingPro Tips highlight that LivaNova's liquid assets exceed its short-term obligations, providing the company with a healthy liquidity position. Moreover, analysts predict that LivaNova will become profitable this year, which may be a pivotal factor for investors considering the long-term prospects of the company. For those seeking deeper insights, InvestingPro offers 10 additional tips on LivaNova, which could be accessed with an exclusive 10% discount using the coupon code PRONEWS24 for a yearly or biyearly Pro and Pro+ subscription.
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