Projects

Nerivio Migra Wearable Neurostimulation Device

Nerivio Migra® is a wearable, smartphone-controlled neurostimulation device indicated for the treatment of acute migraine.

Type

Neurostimulation device

Developer

Theranica Bioelectronics

Application

Acute migraine

Development Status

Approved in the US

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Nerivio Migra® is a wearable, smartphone-controlled neurostimulation device indicated for the treatment of acute migraine.

The unit provides safe and effective relief from migraine pain without any side effects, which are typically seen in the use of therapeutic drugs.

Developed by Theranica Bioelectronics, the device received a De Novo approval from the US Food and Drug Administration (FDA) for clinical use in May 2019. The FDA classified the device as a distal transcutaneous electrical stimulator for the treatment of acute migraine.

Nerivio Migra design and features

Nerivio Migra is a non-invasive electronic device powered by a non-rechargeable battery. Worn on the upper arm, this integrated device operates through a mobile application and looks like a sports armband.

The device comprises an electronics case, firmware, mobile application software and the armband, which is equipped with electrodes that are covered with hydrogel.

The plastic electronics case contains an ON/OFF switch an LED indicator, while the mobile application software is installed and run on a smartphone or tablet. The software controls the device and allows for storage and retrieval of data and records.

How Nerivio Migra works

Nerivio Migra transmits weak electrical pulses on the skin for 45 minutes to produce transcutaneous electrical nerve stimulation, which generates conditional pain modulation (CPM) and inhibits migraine pain.

“Nerivio Migra transmits weak electrical pulses on the skin for 45 minutes to produce transcutaneous electrical nerve stimulation.”

The treatment intensity is indicated on a zero to 100 scale on the output power of the device. The ABORT button can be pressed to stop the treatment.

A biphasic rectangular waveform is delivered via a single channel at a modulated frequency between 100Hz and 120Hz, with 400µs pulse width and output current of up to 40mA. The treatment can be self-administered by the patients at the onset of a migraine attack.

Technology used

The device is integrated with state-of-the-art technology, including various neuromodulation and neuroscience advancements. The innovative design of the device produces a patented waveform that is delivered to C-fibre nerves, which trigger pain-lowering mechanism of analgesics in the brain stem.

The company uses electrical nerve stimulation technology, neuromuscular electrical stimulation (ENS/NMES) and Bluetooth low-energy (BLE). It utilises the company’s patent-pending Maximum Effectiveness (ME) mechanism to collect and determine electromyography (EMG) signals from the treated muscle.

Clinical studies on Nerivio Migra

The FDA’s approval of the Nerivio Migra neurostimulation device was based on a prospective, randomised, double-blind, sham-controlled, multi-centre clinical trial, which enrolled 296 participants with acute migraine. The trial was conducted at seven sites in the US and five sites in Israel.

Patients were randomised to 1:1 ratio to receive stimulation either via the active or sham device for 30-45 minutes on the upper arm within one hour of the onset of a migraine. The sham device produced stimulation at a lower pulse width and frequency.

The primary endpoint of the study was the percentage of patients with reduced migraine headache after two hours of treatment. Stimulation with the active device was found to be more effective than the sham device, lowering migraine headaches in 66.7% of patients compared to 38.8% of patients receiving stimulation via the sham device.

The active device was therapeutically beneficial to 27.9% of patients, while approximately 37.4% were pain-free after two hours of treatment. Adverse events (AE) related to the device were also low.

Marketing commentary on Theranica

Founded in 2016, Theranica is an Israel-based biomedical technology company focused on developing wireless technology using advanced neuromodulation therapy to treat medical conditions and diseases such as migraine headaches.

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