LivaNova PLC LIVN has announced that it received the approval of the United States Centers for Medicare & Medicaid Services (“CMS”) for its protocol for RECOVER study on vagus nerve stimulation (VNS). RECOVER is a multi-center, randomized controlled blinded trial that demonstrates the safety and effectiveness of VNS Therapy System as adjunctive therapy compared with a no stimulation control in patients with Treatment-Resistant Depression (TRD).
As a breakthrough for LivaNova, in February this year, the CMS modified the National Coverage Determination (NCD) from non-coverage to a Coverage with Evidence Development (CED) framework in which CMS will cover the LivaNova Vagus Nerve Stimulation Therapy (VNS Therapy) for patients registered for the approved study. Apart from this, CMS will also cover device replacement for patients with a VNS Therapy device for TRD.
As the study protocol has been finalized, the company will now be ready to activate the sites, where the patients can enroll themselves and be part of the study. With this approval, LivaNova expects to improve its foothold in the global VNS market.
Significance of the Access
There are people around, who are suffering from depression that is difficult to treat. The study mainly aims to provide such people access to a potentially life-altering treatment option. Per management, depression is considered to be the leading cause of disability in the United States at present and given this scenario, this nod has come at just the right time.
The main feature of RECOVER is that it is a double-blind, randomized, placebo-controlled study, with a follow-up duration of at least one year. The CED also includes the possibility of extending the study to a prospective longitudinal study.
The enrollment program will likely start later in 2019 and, include up to 500 unipolar and bipolar patients each at maximum 100 sites in the United States.
How is This Superior to Traditional VNS Therapy?
Over time, VNS Therapy for TRD has proved highly effective and has helped improve response and remission rates significantly when used as a supplementary therapy. With the approval, the company aims to use this study to learn more about the effectiveness of VNS for TRD. Also, it aims to reach out to more patients, who are in dire needs of better treatment.
The company expects to retain the positive momentum, which it already created while the enrollment and study will take some time to make further positive impact.
Per a report by ResearchAndMarkets, the global vagus nerve stimulator market has been emerging competently from 2019 to 2027 with a CAGR of 7.4%. This is based mainly on the rise in the minimally invasive surgical procedures along with enhanced vagus nerve stimulation therapies. Given the current growth prospects, the timing of the approval is apt for the betterment of the company.
Some Recent Developments
On Jul 16, 2019, the company launched the state-of-the-art arterial femoral cannula, Bi-Flow, designed to prevent limb ischemia during cardiac surgery. Leg ischemia is caused by disruption of blood flow to a lower limb and may cause higher mortality and morbidity, and longer hospital stays.
On Jul 15, the company announced receiving the 510(k) consent from the FDA for its new Advanced Circulatory Support (ACS) pump and controller, the LifeSPARC system. The system provides temporary support for emergent rescue patients in a variety of situations.
Share Price Performance
The stock has gained 7.6% in the past three months compared with the industry’s growth of 0.6% and the S&P 500 index’s rally of 2.9%.
Zacks Rank & Other Key Picks
Currently, LivaNova sports a Zacks Rank #1 (Strong Buy). A few other top-ranked stocks from the broader medical space are Baxter International Inc. BAX, GW Pharmaceuticals PLC GWPH and Neurotrope, Inc. NTRP.
Baxterwith a Zacks Rank #2 (Buy), has a projected long-term earnings growth rate of 12.8%. You can see the complete list of today’s Zacks #1 Rank stocks here.
GW Pharmaceuticals estimates third-quarter earnings growth rate to be 72.8%. It currently sports a Zacks Rank #1.
Neurotrope, with a Zacks Rank #2, has a projected third-quarter earnings growth rate of 27.7%.
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