Theranica wins USFDA nod for smartphone controlled migraine relief wearable device
Nerivio Migra, a first-in-category product, is placed on the upper arm (not the head or neck) and uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response. Nerivio Migra is indicated for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine.
NETANYA: Theranica, a bio-medical technology company developing advanced electroceuticals for migraine and other pain disorders, announced recently that the U.S. Food and Drug Administration (USFDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, utilizing Remote Electrical Neuromodulation for the acute treatment of migraine.
The USFDA market authorization is based on the results of a prospective, randomized, double-blind, placebo-controlled, multi-centre pivotal study, where 252 patients from 12 clinics used the non-invasive wearable to treat their migraine attacks.
Nerivio Migra, a first-in-category product, is placed on the upper arm (not the head or neck) and uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response. Nerivio Migra is indicated for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine.
Alon Ironi, CEO and co-founder of the Theranica said, "While the company is preparing to launch the Nerivio Migra in the United States market later this year at an affordable price, we remain committed to continuing our clinical development, expanding the use of remote electrical neuromodulation therapy for additional indications."
"We have identified at least 7 different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development, " Alon added.
Migraine is the third most common disease in the world, with an estimated global prevalence of 14.7% of the world's population1. Migraine results in $17 billion of annual health costs in the U.S. alone. In a study2 conducted with 2,444 people suffering from migraine, two-thirds delayed or avoided taking their prescription medications due to concerns about adverse side effects, and 79% sought products with similar efficacy but fewer side effects.
Also Read: Eli Lilly new migraine drug Emgality pulls ahead of Amgen in battle for prescriptions
NETANYA: Theranica, a bio-medical technology company developing advanced electroceuticals for migraine and other pain disorders, announced recently that the U.S. Food and Drug Administration (USFDA) granted a De Novo request for its smartphone-controlled electroceutical, Nerivio Migra, utilizing Remote Electrical Neuromodulation for the acute treatment of migraine.
The USFDA market authorization is based on the results of a prospective, randomized, double-blind, placebo-controlled, multi-centre pivotal study, where 252 patients from 12 clinics used the non-invasive wearable to treat their migraine attacks.
Nerivio Migra, a first-in-category product, is placed on the upper arm (not the head or neck) and uses smartphone-controlled electronic pulses to create a Conditioned Pain Modulation (CPM) response. Nerivio Migra is indicated for acute treatment of migraine with or without aura in adult patients who do not have chronic migraine.
Alon Ironi, CEO and co-founder of the Theranica said, "While the company is preparing to launch the Nerivio Migra in the United States market later this year at an affordable price, we remain committed to continuing our clinical development, expanding the use of remote electrical neuromodulation therapy for additional indications."
"We have identified at least 7 different painful conditions that may be relieved by this non-invasive, drug-free technology after appropriate clinical development, " Alon added.
Migraine is the third most common disease in the world, with an estimated global prevalence of 14.7% of the world's population1. Migraine results in $17 billion of annual health costs in the U.S. alone. In a study2 conducted with 2,444 people suffering from migraine, two-thirds delayed or avoided taking their prescription medications due to concerns about adverse side effects, and 79% sought products with similar efficacy but fewer side effects.
Also Read: Eli Lilly new migraine drug Emgality pulls ahead of Amgen in battle for prescriptions
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