New Study Suggests REN Comparable to Standard Care Prescribed Medications

Acute Treatment of Chronic Migraines

Analysis of Clinical Trial Data Shows No Difference in Effectiveness Outcomes Between Use of Remote Electrical Neuromodulation (REN) Device Nerivio® and Tested Medications

NETANYA, Israel and MONTCLAIR, N.J., Sept. 19, 2022 /PRNewswire/ -- Theranica, a prescribed digital therapeutics company developing advanced digitally-connected neuromodulation devices for migraine and other pain conditions, announced today the publication of a new study comparing the effectiveness of Remote Electrical Neuromodulation (REN) to that of standard-care medications for the acute treatment of chronic migraine. The post-hoc analysis published in the Journal of Pain Management concludes that REN, administered by Theranica's flagship therapeutic wearable Nerivio®, provides an effective non-pharmacological alternative for standard-care abortive medications in individuals impacted by chronic migraine.

"Chronic migraine is an especially disabling condition, diagnosed when a migraine patient experiences at least 15 migraine-induced headache days per month," said Brian Grosberg, MD, Director of the Hartford Healthcare Headache Program, who served as the primary investigator of the study. "The recent Consensus Statement of the American Headache Society recommends that, in order to avoid medication overuse, patients with migraine who need to use acute treatments on a regular basis should be instructed to limit medication use to an average of two headache days per week."

Grosberg added, "Chronic migraine patients often have four, five or even six headache days per week. To treat them effectively and safely we must expand the first-line standard-care treatment options beyond prescribed medications. This research provides a strong comparison of REN to prescribed medications, mainly triptans, reinforcing the conclusion that REN provides a much-needed alternative to standard-care acute migraine treatment - without compromising effectiveness."

Prospective data from 78 adult chronic migraine patients in the U.S. demonstrated effectiveness of REN across four parameters in comparison to standard-care medications. The analyzed parameters included single-treatment pain relief and pain-freedom post 2 hours, as well as consistent pain relief and pain freedom across multiple treatments. In 62.8% (49/78) of the patients, REN led to significant single-treatment pain relief two hours post treatment, as opposed to only 48.7% (38/78) with medication usage (p=0.056 [McNemar Test]). Additionally, 64.1% of the patients achieved consistent pain relief with REN, compared to 57.7% when using standard-care medications. Single treatment pain relief was achieved in 23.1% of migraine sufferers when using REN, in comparison to 19.2% with medication usage. Both REN and medication achieved 14.1% consistency of pain freedom across multiple treatments.

Worn on the upper arm at the onset of a migraine attack, Nerivio® uses REN technology to alleviate migraine headache and associated symptoms by triggering an endogenous analgesic mechanism, known as conditioned pain modulation (CPM). The device is controlled via a smartphone app, allowing patients to set the intensity of their treatment as well as maintain a built-in migraine diary that can easily be shared with physicians for improved migraine tracking and management.

"The results of this study further reinforce the very large body of evidence validating the efficacy of REN and Nerivio in various migraine patient populations," said Ivan Gergel, MD, Managing Partner and CMO of New Rhein Healthcare Investors and a member of Theranica's board of directors. "This is very meaningful for health care and health insurance systems in the U.S. who always seek ways to provide their members with access to safe, effective therapeutics for chronic conditions."

Nerivio is a prescribed, digitally connected wearable. Clinical studies have shown that Nerivio is effective and safe for the treatment of episodic and chronic migraine in individuals aged 12 and older.

About Theranica

Theranica is a prescribed digital therapeutics company dedicated to creating effective, safe, affordable, low-side effect therapies for idiopathic pain conditions. The company's award-winning flagship product, Nerivio®, is the first FDA-cleared smartphone-controlled prescribed wearable device for acute treatment of migraine, and already serves over 40,000 people with migraine in the USA, including adolescents and veterans. Theranica is expanding its proprietary technology to develop solutions for additional idiopathic pain conditions. Nerivio has received FDA authorization and CE mark for use in acute treatment of episodic and chronic migraine in adult and adolescent patients.