Digital therapeutics firm Neurolief has secured the European CE-Mark to market, sell and distribute its Relivion device as a digital migraine treatment.
Relivion has been developed as a non-invasive, multi-channel brain neuromodulation technology that is said to deliver therapy similar to surgical implants.
The system is available with an adjustable headset that simultaneously delivers modulated pulses through adaptive output channels around the head to six branches of the occipital and trigeminal nerves.
It is Cloud-enabled and linked to a mobile phone app. The device is designed to learn over time and provide personalised therapy for individual patients.
Patients can self-administer the new system at home. It avoids the risks and costs that come with invasive procedures as well as the side effects associated with medications, noted Neurolief.
Neurolief co-founder and CEO Shmuel Shany said: “We designed the Relivion to be a self-administered, safe and attainable alternative to high-cost and high-risk surgical implants, accelerating migraine relief for migraine sufferers in a non-invasive manner.
“We believe the Relivion will be instrumental in giving patients more rapid relief, increased productivity, and the ability to get back to their lives.”
The device obtained the CE-Mark based on results from a randomised, double-blind, placebo-controlled clinical trial that demonstrated safety and efficacy in patients with migraine headache.
Data found 76% of the patients felt relief from headaches after one treatment without any serious adverse effects.
Neurolief chief medical innovation officer Dr Eran Schenker said: “We hypothesise that the disruptive technology synergistic neuromodulatory effect elicited by concurrent activation of both the occipital and trigeminal neural pathways contributes to the superior therapeutic results shown.”
Future generations of the technology are set to feature artificial intelligence (AI) and machine learning algorithms required to analyse data from each user and to accurately predict migraines.
The company is also planning to expand the application of its neuromodulation technology to other neurological and neuropsychiatric disorders, including depression.