The Nerivio REN wearable is redefining pediatric migraine care as the only migraine-specific preventive therapy for children under the age of 12.

BRIDGEWATER, N.J. and NETANYA, Israel, Dec. 10, 2024 /PRNewswire/ -- Theranica, a prescribed neuromodulation therapeutics company, today announced significant milestones in 2024, including a recently released study highlighting barriers and preferences when treating migraine at school. Other achievements this year include an expanded age indication from the FDA, clearing the treatment for use in patients aged eight and older; the appointment of a new chief medical officer; and improved access and affordability with insurance coverage reaching 30 million people.

Addressing Migraine at School with the REN Wearable

A study published in Children, a peer-reviewed publication, highlights the challenges children and adolescents face in treating migraine at school, emphasizing key barriers such as lack of access to treatment, inconvenience to treat in class, and social stigma. In the study, 64.2% of the 332 young participants reported having to leave the classroom to receive drug treatment from the school nurse as a primary hindrance to treating migraine during school, while 42.2% mentioned the perception of being "different." With the discreet Nerivio REN wearable, however, 65.4% of the participants were able to manage their migraine in the classroom at the start of symptoms, either as a standalone treatment or in conjunction with other treatments. This allowed students to avoid leaving the classroom and initiate treatment independently, putting them in control of their migraine without disruption or stigma.

This study emphasizes the importance of the REN wearable as a discreet, effective, and independent first-line treatment, reducing disruptions and addressing challenges faced by students managing migraine at school.

"The REN wearable offers advantages over traditional pharmacological treatments in terms of accessibility, reducing learning disruptions, reducing social stigma, and fostering autonomy," said Dr. Andrew D. Hershey, MD, PhD, FAAN, FAHS, Endowed Chair and Director of Neurology, Cincinnati Children's Hospital Medical Center and Professor of Pediatrics and Neurology, University of Cincinnati School of Medicine. "Use of REN in the classroom allows for the student to treat at the onset, thus reducing the time suffering from the headache due to migraine. The findings suggest that REN improves treatment adherence at school, reducing the portion of students who either avoid treatment or rely solely on pharmacological medications. Given the need for timely intervention, this study has immediate clinical implications for school-aged children living with migraine."

FDA Expands Age Indication for the Nerivio REN Wearable

In October, the FDA cleared the Nerivio REN wearable for patients as young as eight, making it the first FDA-cleared, non-drug option for acute migraine treatment in children and the only prescribed preventive treatment of migraine for this age group. Until now, there has been a reliance on drugs to treat pediatric migraine, many of which were not originally developed for this purpose and have not been evaluated for use in children. Additionally, these drugs often come with poor tolerability and disruptive, systemic side effects, such as nausea, dizziness, and fatigue.

The REN wearable is redefining migraine intervention by addressing key shortcomings with pharmacologic treatments. This FDA-clearance is especially critical to mitigate the risk of long-term disability and disease progression in children and adolescents providing a safe, effective treatment for early intervention. Treating migraine with the REN wearable also improves overall quality of life by allowing kids to stay active in their studies and participate socially with friends.

Dr. Angel S. Angelov, M.D. Joins Theranica as Chief Medical Officer

Dr. Angelov, with over 20 years in pharmaceutical clinical development and medical affairs, will bring his expertise to Theranica's mission. He completed his residency and fellowship trainings at Thomas Jefferson University in Philadelphia and is a diplomate of the American Board of Psychiatry and Neurology. As Chief Medical Officer, Dr. Angelov will provide global oversight of medical affairs and assist with initiatives to improve access to and affordability of the Nerivio REN wearable.

"As a physician deeply committed to improving pediatric and preventive care, it is a privilege to join the Theranica team and provide my expertise to help advance the initiatives of the company," said Dr. Angelov. "The REN wearable is a much-needed, drug-free option for treating pediatric migraine and I look forward to expanding accessibility to the product and help positioning it as a first-line treatment for migraine."

One Million Treatments and Broader Insurance Coverage

In a landmark achievement, the Nerivio REN wearable surpassed one million treatments in the U.S. this October, underscoring the growing recognition and adoption of a non-drug migraine treatment as an alternative or a supplement to pharmacological medications. This milestone reflects not only the increasing trust among healthcare providers and patients but also the wearable's ability to improve quality of life for users.

Increasing patient access and affordability remains a priority for Theranica. This year, eight payers began covering the Nerivio REN wearable for their members, including Highmark, Blue Cross Blue Shield North Dakota, as well as D.C., Colorado, Arizona, New Jersey, Ohio, and Virginia Medicaid programs. Two additional payers have concluded their respective evaluations with decisions to cover Nerivio in policies that will come into effect and be announced in early 2025. This coverage expansion means that 30 million Americans have reimbursed access to this therapy.

"In 2024, we focused on making Nerivio accessible (with prescription) to U.S. populations in greater need for a non-drug therapy—including children, adolescents, veterans, and pregnant women. In parallel, we expanded the availability of the Nerivio REN wearable internationally in Germany, India, Spain, South Africa, and the UK, through our partnership with Dr. Reddy's Laboratories," said Alon Ironi, CEO and cofounder of Theranica. "With the recent FDA's expanded indication, Nerivio becomes the first and only FDA-cleared preventive and acute migraine treatment for children as young as eight—a milestone that addresses the gaps in current care for the 10% of children impacted by migraine disease. By focusing on the issues that truly matter to families, we're seeing a positive response from the market, signaling that the old standard of care is insufficient for patients with migraine."

For more information about The Nerivio REN wearable, please visit Nerivio.com.

About Nerivio

Controlled by a smartphone app and self-administered, the Nerivio REN wearable is a complete migraine care treatment that wraps around the upper arm and uses sub-painful Remote Electrical Neuromodulation (REN) to activate nociceptive nerve fibers in the arm. These fibers send signals that trigger a descending pain management mechanism in the brain called conditioned pain modulation (CPM), which turns off migraine pain and associated symptoms without medication. In simpler terms, the upper arm is stimulated to unleash a natural process in the brain to abort or relieve migraine headaches and other associated symptoms. Each treatment lasts 45 minutes and is applied every other day for prevention or at the start of a migraine attack for acute treatment.

About Theranica

Theranica is a neuromodulation therapeutics company dedicated to creating effective, safe, affordable, low-side-effect therapies for idiopathic pain conditions. The company's award-winning flagship wearable, Nerivio, is the first FDA-cleared prescribed migraine REN wearable for acute and/or preventive treatment of migraine. Nerivio has been used in more than one million migraine treatments in the U.S., including by adolescents and veterans. Theranica is expanding its proprietary technology to develop solutions for additional idiopathic pain conditions. Learn more by visiting our websites, theranica.com and nerivio.com, and following us on LinkedIn, X (formerly Twitter), Instagram, and Facebook.

Theranica Contact:

Ronen Jashek
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+972-72-390-9750

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SOURCE Theranica