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US doctors offer drug-free migraine relief from Israeli startup

Theranica’s wearable, FDA-cleared Nerivio device shows electrical stimulation can be as effective as drugs and injections – or even better

Image: Theranica
Image: Theranica

Anna Williams, a digital creator from New Albany, Indiana, began suffering from migraines as a child. She also has chronic cluster headaches as well as atypical facial pain. In June 2021 she saw an offer to try out a new, drug-free migraine treatment device called Nerivio, with an insurance co-pay of just $10.

Soon after, Anna woke up with a visual aura she recognized as the onset symptoms of a migraine. She grabbed the device, which transmits small electronic signals, and strapped it to her arm as instructed.

“The aura lasted the normal 20 minutes. The head pain never came,” she says. “I still felt tired, but the difference is amazing.”

Two years on, she is still using it to manage the attacks and she has become a prominent patient advocate on behalf of migraine sufferers.

“It helps,” she says. “On bad attacks I will often use it and take my meds so it will reduce the pain levels during the time it takes my meds to kick in. I love how Nerivio is so easy to use.”

Anna’s 14-year-old daughter also suffers from episodic migraines. In 2021, Nerivio was cleared by the FDA for children aged 12 and older so they decided to try it.

“She went from being unable to concentrate and work on her schoolwork to feeling like she can go back to work again,” Anna says. “Her light sensitivity and pain levels are both drastically reduced.”

Migraine affects at least 37 million people in the US and around 1 billion people worldwide – more than 10 percent of the global population. Nerivio, the first drug-free wearable device cleared by the FDA to treat migraine, was created by Theranica, an Israeli startup based in Netanya. It is producing remarkable results for thousands of patients like Anna Williams and her family.

Nerivio, worn on the patient’s arm, emits electric stimulation that triggers a pain-killing response from the central nervous system to the neural pathways of migraine symptoms in the brain. It was selected as one of Time magazine’s 100 best inventions for 2019.

During a migraine attack, the system, which is connected to a smartphone app, monitors the intensity of the patient’s pain and releases electronic pulses that stimulate subcutaneous nerves, which reach the brain stem and trigger a response that causes the release of analgesic neurotransmitters, reducing the intensity of the pain.

In December, Highmark Health in Pennsylvania, one of America’s leading health insurance organizations, became the latest US provider to offer Nerivio to its members as part of a pilot program.

“With more than 37 million Americans suffering from migraine, a debilitating disorder that significantly impacts quality of life, we are glad to be able to offer Nerivio, a drug-free, clinically validated treatment option,” says Andrea Synowiec DO, FAAN, System Vice Chair, Department of Neurology, Associate Professor of Neurology and Assistant Director of the headache center of The Allegheny Health Network, owned by Highmark Health.

“Nerivio is an excellent treatment option for our patients with migraine, especially those who do not respond to medications, or cannot tolerate their side effects,” Dr. Synowiec says. “It’s also effective for teenagers who struggle with migraine and gives them a drug-free treatment option.”

Many standard pharmaceutical treatments for migraine have unfavorable side effects, leaving some patients without a remedy to this often-debilitating condition. Nerivio has been granted FDA De Novo clearance and CE clearance for acute treatment of migraines and is under FDA review for preventive treatment.

Theranica has established a network of over 2,500 US physicians who have prescribed Nerivio to over 35,000 patients who together have used it more than 300,000 times.

Nerivio utilizes remote electrical neuromodulation (REN) to trigger a pain inhibition mechanism, known as conditioned pain modulation (CPM) which eases or completely blocks migraine headaches and associated migraine symptoms. It can be used as a stand-alone treatment or in combination with other therapies.

Point 32 Health, the parent organization of Harvard Pilgrim Health Care and Tufts Health Plan, is conducting a year-long pilot of Nerivio for its members.

“Many of my patients have found Nerivio to be highly efficacious for them,” says Sait Ashina MD, Assistant Professor of Neurology and headache specialist in Beth Israel Deaconess Medical Center, Harvard Medical School in Boston. “Given the multifaceted complexity of migraine, it’s essential that patients have access to a wide range of therapies, both pharmacological and drug-free.”

In a double-blind, randomized, placebo-controlled, multi-center clinical trial conducted by Theranica in the US in 2021-2020, subjects who used Nerivio every other day experienced a reduction of 4.0 migraine days per month from baseline, compared to a reduction of 1.3 days in the placebo group.

The results suggest that Nerivio was effective even when patients are also taking pharmaceutical treatments for migraine prevention, including oral medications and injections of Botox or CGRP monoclonal antibodies, reducing the effects of migraine beyond the relief offered by these drugs.

“These data demonstrate Nerivio’s potential to provide a new non-pharmacological preventive treatment option for people with migraine,” says Brian Grosberg, MD, Director of the Hartford Healthcare Headache Program in Connecticut and primary investigator of the study. “The high efficacy of Nerivio compared to placebo, with favorable safety and tolerability, suggests that remote electrical neuromodulation could be a beneficial non-pharmacological therapy option for both preventive and acute treatment of migraine, subject to FDA approval of the preventive indication.”

Theranica, recently selected to be part of Google’s Startup Growth Lab accelerator, was founded in 2016. In August 2022, the company announced a first $45 million closing of its Series C funding round led by Philadelphia-based New Rhein Healthcare Investors, with the participation of existing investors aMoon, Lightspeed Venture Partners, LionBird, Takoa Invest, and Corundum Open Innovation. The round is still open and funding via the OurCrowd platform.

“There is a growing recognition that certain chronic pain diseases, such as migraine, may be treated with therapies other than pharmacological agents, or in combination with those. This is validated by clinical evidence from randomized controlled studies,” says Alon Ironi, Theranica CEO, who says the company is raising investment “to unleash the huge potential of Nerivio in the US.”

Dr. Shimon Eckhouse, chairman and co-founder of Theranica, is a serial medical entrepreneur involved in founding several Israeli startups including cosmetic surgery company Syneron Medical, medical laser company Lumenis, and RealView Imaging, creator of a 3D holographic medical visualization system.

Theranica is currently funding on the OurCrowd platform. For more information, click HERE.

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