Neurolief has secured CE mark approval for its Relivion non-invasive and adaptive neuromodulation digital treatment for migraine.
The CE mark enables the company to market, sell and distribute the Relivion device as an over-the-counter therapy within the European Union and countries, which enter into agreements on mutual recognition of conformity assessment.
Relivion is claimed to be the first non-invasive and adaptive multi-channel brain neuromodulation technology, which provides effective therapy with reduced risks and costs associated with invasive procedures and without the side effects related to medications.
The company has designed the Relivion system to simply and safely self-administer at home with reduced cost compared to surgical implants.
The new device is provided with a comfortable and adjustable headset to offer precise modulated pulses simultaneously to six branches of the occipital and trigeminal nerves through various adaptive output channels around the patient’s head.
Neurolief’s advanced cloud-enabled device can be connected to a proprietary mobile phone app and it holds capacity to deliver personalised treatment for each patient through learning over time.
The approval was based on data from a randomised, double-blind and placebo-controlled clinical study, which demonstrated very high efficacy and safety of the Relivion in treatment of migraine headache.
According to the company, around 76% of the participants achieved headache relief after only one treatment without any serious adverse effects.
Neurolief co-founder and CEO Shmuel Shany said: “This CE mark for the Relivion system marks a vital step in providing patients with alternative, non-drug technology-driven treatments.
“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.”
Neurolief is involved in the development of next-generation digital therapeutics brain neuromodulation technology for the treatment of neurological and neuropsychiatric disorders such as migraine and depression.