LivaNova Enters Research Collaboration with Verily to Gain New Insights into Vagus Nerve Stimulation Impact on Difficult-to-Treat Depression

LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today announced a research collaboration with Verily, an Alphabet company, to capture measures of depression within its RECOVER clinical study, which is evaluating the effectiveness of Vagus Nerve Stimulation Therapy^® (VNS Therapy) for Difficult-to-Treat Depression (DTD). Through this initial research collaboration, Livanova and Verily aim to gather quantitative data on patient behavior using technology and analytics developed by Verily to further understand depressive episodes and a patient’s response to treatment. RECOVER clinical sites will have the ability to offer patients the Verily Study Watch, a wearable device designed to capture physiological and environmental data for clinical research, and a Verily mobile phone app. These complementary approaches are expected to help investigators better understand the impact of depression and its treatment on study participants’ lives in a more objective and multi-dimensional manner.

Major depressive disorder (MDD) is a leading cause of disability, morbidity and mortality worldwide.¹ In fact, for as many as one in three patients, medication alone may not be enough, leading them to struggle daily with persistent feelings of sadness, hopelessness, poor sleep and thoughts of death or suicide.²

"Finding new solutions to help those who suffer from Difficult-to-Treat Depression promises to truly transform patients’ lives,” said Dr. William Marks, head of Clinical Science and Neurology at Verily. "We look forward to working with LivaNova to gather additional data and evidence on VNS Therapy for Difficult-to-Treat Depression with the potential for collaboration on other areas of research in the future.”

RECOVER participants with an Android device can opt-in to a sub-study where they will use the Verily Study Watch and a mobile phone app designed to measure passive and interactive data. These data will supplement qualitative data to provide clinicians a more comprehensive view of whether a patient’s depression is improving, staying the same or worsening. Verily technology can provide measures such as heart rate, activity level, sleep quality and various other domains of function, including patient-recorded voice logs with the goal of more accurately assessing depression and its effect on daily living.

"The goal of the RECOVER study is to assess how VNS Therapy can offer patients with DTD relief from their symptoms and improve their quality of life,” said Damien McDonald, Chief Executive Officer of LivaNova. "Through this collaboration with Verily, we can build on our work to study depression and better understand the complex elements that contribute to the disorder, enhancing our ability to treat the patients who battle it.”

For additional information on the RECOVER clinical study, please visit www.RecoverVNS.com.

About VNS Therapy for Depression

The VNS Therapy System, Symmetry™, is indicated in the U.S. for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. Symmetry is indicated outside the U.S. for the adjunctive long-term treatment of chronic or recurrent depression in patients that are in a treatment-resistant or treatment-intolerant major depressive episode. Commonly reported side effects are hoarseness, shortness of breath, sore throat and coughing. Side effects typically occur during stimulation and are less noticeable over time. Safety information is available at www.symmetryvns.com/resources.html.

About LivaNova

LivaNova PLC is a global medical technology and innovation company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through innovative medical technologies, delivering life-changing improvements for both the Head and Heart. Headquartered in London, LivaNova employs approximately 4,000 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals and healthcare systems worldwide. LivaNova operates as two businesses: Cardiovascular and Neuromodulation, with operating headquarters in Mirandola (Italy) and Houston (U.S.), respectively.

For more information, please visit www.livanova.com.

Safe Harbor Statement

This news release contains "forward-looking statements” concerning our goals, beliefs, expectations, strategies, objectives, plans and underlying assumptions and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding VNS Therapy and its use for patients with Difficult-to-Treat Depression. Actual results may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2018, as supplemented by any risk factors contained in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. We undertake no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

References

1. The economic burden of treatment-resistant depression. Olchanski N, McInnis Myers M, et al. Clin Ther. 2013 Apr;35(4):512-22.
   
2. STARD: Rush AJ, Trivedi MH, Wisniewski SR, et al. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006;163(11):1905–1917

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