DTx Product Profile

Nerivio®

Product Highlight

Condition targeted:

Migraine

How it works:

Nerivio is a wireless wearable neuromodulation unit controlled by a smartphone app. Treatments with Nerivio are self-administered by the user at the onset of a migraine attack.

  • Applied to the upper arm as soon as a migraine begins
  • Treatment is started and the intensity is adjusted to a “tingling” that is not painful
  • Treatment lasts 45 minutes

Impact:

7 migraine patients out of 10 using Nerivio see significant pain relief; 4 out of 10 experience pain freedom.

Product Overview

Medical conditions:

Migraine

Target patient population:

For migraine patients with or without aura, 12 years of age or older. For those seeking a clinically-proven drug-free solution, or those that do not respond to prescribed medications and/or cannot tolerate their side-effects.

What to expect:

Provides significant pain relief to 7 out of 10, and pain freedom to 4 out of 10 patients treated with Nerivio.

Clinical Overview

Indications for use:

Nerivio® is a non-pharmacological, non- invasive, wireless, wearable, battery-operated, remote electrical neuromodulation (REN) stimulation device for the treatment of migraine. Nerivio is self-administered by the patient, controlled by a smartphone app, and FDA cleared for acute treatment of migraine with or without aura in patients 12 years of age or older.

Outcomes:

Nerivio has been proven effective in two prospective double-blinded sham controlled randomized controlled trials (RCTs). 66.7% achieved pain relief [p< 0.0001] and 37.4% achieved pain freedom [p<0.005]

Directions:

Nerivio device is a wireless wearable battery-operated stimulation unit controlled by a smartphone software application. Treatments with Nerivio are self-administered by the user at the onset of a migraine attack.
a) Nerivio is applied to the upper arm as soon as a migraine begins
b) Treatment is started and the intensity is adjusted to a “tingling” that is not painful
c) 45 minutes is the recommended treatment time

Risks & warnings:

Nerivio should not be used by people with congestive heart failure, severe cardiac or cerebrovascular disease, or uncontrolled epilepsy. Nerivio should not be used by anyone with active implantable medical devices (e.g. pacemaker, hearing aid implant).

Place in therapy:

Nerivio can either replace current therapy or work in conjunction with existing

Product Access

Product description:

Nerivio device is a wireless wearable battery-operated stimulation unit controlled by a smartphone software application. Treatments with Nerivio are self-administered by the user at the onset of a migraine attack. Nerivio is fully operated by an app, controlling the treatment, providing fully-featured migraine diary, personalized analytics and tips for the patient and more.

Prescription status:

A prescription from a qualified healthcare provider is required.

Patient access:

Patients obtain a prescription from their healthcare provider or via a telemedicine service. Nerivio is sent to patient’s home within 24-48 hours. Patients download the Nerivio app, register and log-in, and start using Nerivio to treat their migraines.

Provider access:

Healthcare providers may access their patients migraine diary by having the patient share the info from within the app. A dedicated Nerivio-HCP dashboard is under development to allow providers access to monitor their patients migraine trends, potential medication-related issues, and view patient-generated health data. This dashboard will be accessible through the Nerivio clinician web portal.
Nerivio is also integrated with many of major EHRs to ensure that data is securely shared with the patient record.

Coverage options:

The company is actively pursuing options for reimbursement to ensure patients have access to this product.

Product availability:

Nerivio is available in:

Unique Features

Nerivio, is an innovative FDA-authorized, non-invasive, smartphone-operated, prescribed wearable for the acute treatment of migraine in patients 12 years of age or older.

In November 2019 Nerivio was named one of TIME’s 100 Best Inventions of the year under the healthcare category.

Nerivio® is endorsed by the American Headache Society (AHS) in its June 2021 guidelines for treating migraine.

Clinical Trials

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