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LONDON - LivaNova PLC (NASDAQ:LIVN), a medical technology company with a market capitalization of $2.4 billion and impressive gross profit margins of 69%, has initiated a process with the U.S. Centers for Medicare and Medicaid Services (CMS) to reconsider national Medicare coverage for its Vagus Nerve Stimulation (VNS) Therapy™ in patients with treatment-resistant depression (TRD). InvestingPro analysis reveals several promising indicators for the company, with 6 additional key insights available to subscribers. The request is based on the RECOVER clinical study’s 24-month data, which shows sustained benefits of VNS Therapy.
The company’s submission includes five peer-reviewed articles that analyze the RECOVER study’s primary and secondary endpoints, demonstrating improvements in symptoms, function, and quality of life in TRD patients. These articles meet the Coverage with Evidence Development (CED) requirements set by CMS.
According to the 24-month top-line data, patients receiving active VNS Therapy retained approximately 81.3% of their clinical benefits across all outcome measures, with response rates increasing from 40.2% at 12 months to 51.6% at 24 months. This clinical progress comes as LivaNova demonstrates solid revenue growth of 7.62% over the last twelve months. InvestingPro data shows the company maintains a GOOD Financial Health Score, suggesting strong operational fundamentals despite current market challenges. Researchers highlight this as significant durability and increasing benefit, a claim not demonstrated by other therapies, including pharmacotherapies and interventional therapies like electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS).
Additionally, an analysis on suicidality within the first 12 months of the RECOVER study indicated a 43% higher odds of improvement in suicidal ideation symptoms in the active treatment group compared to the control group, with a notable separation between the two as early as month three.
The RECOVER study is the largest randomized clinical trial of its kind, involving 493 adults who have unsuccessfully tried at least four antidepressant treatments. VNS Therapy™, approved for the treatment of depression since 2001 in Europe and 2005 in the U.S., is being evaluated for its efficacy as an adjunctive treatment in TRD.
LivaNova’s Chief Innovation Officer, Ahmet Tezel, Ph.D., emphasized the importance of considering symptoms, function, and quality of life together for a more complete picture of treatment effectiveness. The company is poised to present this data to CMS during the reconsideration process.
The press release also mentions that no new safety issues were identified during the study, reinforcing the therapy’s safety profile. According to InvestingPro’s Fair Value analysis, LivaNova appears undervalued at its current price of $44.10, with analysts predicting profitability this year. For detailed insights and comprehensive analysis, investors can access the full Pro Research Report, available for over 1,400 US stocks including LivaNova.
The submission to CMS is part of the National Coverage Determination (NCD) process, which LivaNova hopes will result in expanded access to VNS Therapy™ for patients with TRD. The company’s request is supported by the comprehensive data from the RECOVER study, which was completed in March 2024 for the unipolar cohort.
This article is based on a press release statement from LivaNova PLC.
In other recent news, LivaNova PLC reported first-quarter 2025 earnings and revenue that exceeded analyst expectations. The company posted adjusted earnings per share of $0.88, surpassing the consensus estimate of $0.76, with revenue reaching $317 million, marking an 8.9% growth on a constant currency basis. Following these results, LivaNova raised its full-year 2025 revenue guidance to a range of 6-7% growth on a constant currency basis, up from the previous forecast of 5-6%. However, the company adjusted its EPS guidance downward to $3.60-3.70, citing the impact of the SNIA and tariffs. Wolfe Research upgraded LivaNova stock from Peer Perform to Outperform, setting a new price target at $60, noting the resolution of legal issues in Italy and plans to increase the capacity of its oxygenator products. Jefferies analyst Anthony C. Petrone also increased the stock’s price target from $74 to $79, reiterating a Buy rating based on the company’s strong performance in the Heart-Lung Machine segment and Neuro division. Additionally, LivaNova recorded a liability of €333.3 million ($360.4 million) due to a court ruling related to environmental damages, which the company plans to contest. The company also completed its premarket approval submission to the FDA for its aura6000 System to treat obstructive sleep apnea.
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