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Sunday, August 25, 2019

In clinical trials, two-thirds of patients got significant pain relief with Theranica’s Neriva Migra patch. (Credit: Israel21c)

Theranica’s Neriva Migra patch, currently being evaluated by the U.S. FDA, delivers a small electrical jolt to mitigate headache and other acute pain through ‘conditioned pain modulation.’

It looks like a high-tech version of the nicotine patch, but Theranica Bio-Electronics’ wearable device has a different purpose: to knock out migraines … at least temporarily.

Inside Theranica’s Neriva Migra patch are tiny electrodes that deliver a small electrical jolt to your body to mitigate headache and other acute pain through what’s known as CPM (conditioned pain modulation).

CPM is a counterintuitive approach to pain management. The idea is that by introducing a secondary noxious stimulus (the electrical zaps from the patch), perception of the primary noxious stimulus—in Theranica’s case, migraines—can be reduced.

Similar to a nicotine patch, you place the Neriva Migra device on your arm above the elbow. The device communicates wirelessly with your smartphone, which regulates the electrical pulses and sets a timer. A 45-minute treatment can bring relief for pain within two hours.

In Theranica’s clinical trials, involving 252 patients across 12 sites in the United States and Israel, “Around two-thirds of patients got significant pain relief,” said Theranica co-founder and COO Ronen Jashek. “More than 30 percent were pain-free.”

There’s one unavoidable hitch: The pain does come back eventually because this is not a cure.

Theranica’s Neriva Migra device isn’t on the market yet—it’s currently being evaluated by the FDA and clearance is expected in a couple of months. Nor is the business model set, other than it will require a prescription. The cost is hoped to be equivalent to, or less than, common prescription drugs.

Neriva Migra, which began development in 2016, will first be available in the United States, followed by Europe in 2020, according to the company’s plan.

Headaches are, unfortunately, big business. The Migraine Research Foundation estimates that migraines are the third most prevalent illness in the world. In the United States, migraines impact 12 percent of the population (18 percent of women, 6 percent of men).

Several American med-tech companies are in this crowded field. Thirty Madison raised $15 million in 2018 for a tool that tracks migraine incidents and offers virtual consultations with doctors; Healint’s Migraine Buddy tracker is being tested by pharma giant Novartis to see whether chronic migraines induce anxiety and depression; Gammacore makes an FDA-approved device that electrically stimulates the vagus nerve to block migraine pain signals; and Cefaly has an FDA-approved device that delivers micro-impulses to the trigeminal nerve. The latter two are more cumbersome than Theranica’s device.

One of the most promising, and potentially permanent, treatments for migraine is occipital nerve stimulation, in which a small pulse generator is surgically implanted at the base of the skull to send pain-relieving electrical impulses to the brain. But the technique is invasive and can cost tens of thousands of dollars.

Theranica’s device will be significantly less expensive and can be applied at home. No major side effects have shown up during clinical tests, said Jashek.

Could CPM be used for other types of pain beyond migraines since CPM doesn’t require direct stimulation to the part of the body where the pain is?

Absolutely, said Jashek, as long as the pain is of a similar acute nature.

“We won’t be able to address general chronic issues,” he said, “like back or muscle pains.”

By Brian Blum/JNS.org