Dive Brief:
- As part of an ongoing clinical trial of its implanted vagus nerve stimulation (VNS) system in people with hard-to-treat depression, LivaNova is partnering with Verily to offer a wearable device and mobile app meant to help gather additional information on study participants’ behavior.
- Using technology and analytics developed by Google-parent Alphabet’s life sciences research organization, the goal is to “further understand depressive episodes and a patient’s response to treatment,” LivaNova said in the announcement Wednesday.
- LivaNova’s RECOVER study is part of a protocol approved by CMS for the device to be reimbursed through its coverage with evidence development pathway.
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Dive Insight:
The VNS implant sends electrical pulses to the brain, aiming to reduce depression symptoms. First authorized by FDA for the treatment-resistant depression indication in 2005, the neuromodulation approach is meant for people who have failed to gain adequate relief from multiple therapeutic interventions for depression.
LivaNova said clinical trial participants with an Android device can elect to be part of a sub-study with the Verily Study Watch and a phone app “to measure passive and interactive data.” Additional data on heart rate, activity level and quality of sleep, paired with patient-recorded voice logs, can more thoroughly assess the trajectory of a patient’s depression and its impact on daily life, LivaNova said.
The Verily Study Watch has received 510(k) clearance for an electrocardiogram feature and an irregular pulse monitor.
The collaboration could expand into other areas of research in the future, the companies said.
LivaNova recently changed its descriptor for the condition from “treatment-resistant” depression to “difficult-to-treat” depression, or DTD, following an international consensus statement published in the Journal of Affective Disorders suggesting the latter term better encompasses “depression that continues to cause significant burden despite usual treatment efforts.”
CMS greenlit the study protocol six months ago, with LivaNova aiming to enroll up to 500 unipolar and 500 bipolar patients at up to 100 U.S. sites. RECOVER could ultimately enroll an additional 5,800 participants as part of a longitudinal study and continue through 2030, according to the study’s listing on ClinicalTrials.gov.
Formed in 2015, Verily is building its brand — it presented for the first time at J.P. Morgan Healthcare Conference in January — and remains a hot partner for life sciences companies.
Its medtech collaborations include collaborating on Dexcom’s continuous glucose monitor device due out next year and working on atrial fibrillation technologies with iRhythm. The company is also developing microelectronics and digital technologies for ophthalmology with Japanese pharma Santen and studying undiagnosed and untreated sleep apnea with ResMed in hopes of fashioning software to better identify and treat the condition.
Verily has also seen recent changes on key medtech projects. Sanofi, which worked with Verily to launch virtual diabetes clinic Onduo in 2016, pulled back investment from the joint venture late last year. Verily recently exited a multiyear robotic surgery partnership with Johnson & Johnson when the pharma and devices giant opted to buy out its remaining stake in Verb Surgical.
News of the LivaNova-Verily partnership came hours after LivaNova reported fourth quarter financial results, which showed sales in the neuromodulation division, which houses VNS, inched up 0.4% year-over-year to $424.5 million.
LivaNova CEO Damien McDonald said on an earnings call Wednesday the company expects depression device-related sales of roughly $20 million in 2020 from the RECOVER study and replacement implants for CMS-eligible patients, as well as “a modest benefit” from commercial payer efforts.
