Dive Brief:

• A wearable wireless neuromodulation patch for the acute treatment of migraine has received FDA’s De Novo clearance.
• Theranica Bioelectronics’ Nerivio Migra device requires a prescription and is self-administered at home at the onset of migraine headache or aura, which is a series of sensory disturbances that sometimes occur just before a migraine. The patch is worn on the arm.
• The company’s pivotal study supporting the clearance met its primary endpoint of pain relief at two hours post-treatment.

Dive Insight:

Chronic pain is thought to be the largest and fastest-growing market for neuromodulation devices, although the systems that target nerve activity are also used to treat conditions such as Alzheimer's, Parkinson’s and epilepsy in addition to urinary and fecal incontinence and depression.

The devices typically use implanted or externally placed electrodes to stimulate a patient’s spinal cord or peripheral nerves, to block pain signals or prompt neural impulses.

Theranica Bioelectronics’ device is a wearable wireless patch that a patient applies to the arm at the onset of a migraine headache. The noninvasive patch contains a 'smart' chip controlled by a smartphone app that delivers electrical pulses to modulate the sensory nerves under the skin.

In the company's pivotal trial of 252 patients, the device achieved a 66.7% response rate for pain relief at two hours post-treatment, compared with a 38.8% response rate in the placebo group, meeting the study’s primary endpoint.

Statistical significance also was reached on three of four secondary endpoints, including being pain-free two hours after treatment, relief of most bothersome symptoms and relief of both pain and symptoms.

Netanya, Israel-based Theranica earlier this month announced that Omron Ventures joined its $35 million series B funding round led by aMoon. Other investors include Lightspeed Venture Partners, LionBird, Corundum Open Innovation and Takoa. The company said the funds will allow it to market the Nerivio device.

Three other types of noninvasive neuromodulation devices are FDA-approved to treat migraine, according to the Americain Migraine Foundation. They include a neurostimulator in which electrodes are placed on the forehead to stimulate the supraorbital nerves; a stimulator that is placed on the back of the head and delivers magnetic rather than electrical pulses; and a device placed at the side of the neck and uses electrodes to stimulate the vagus nerve.