The US Food and Drug Administration (FDA) has granted breakthrough device designation to the Relivion DP system developed by medical neurotechnology company Neurolief.
Relivion DP system is a non-invasive multichannel brain neuromodulation technology for the treatment of major depression.
The wearable device is designed as an adjunctive treatment to pharmaceutical management of major depressive disorder (MDD) in adults who fail to gain satisfactory improvement from antidepressant medications.
It is similar to a simple headset that the patient places on their head to stimulate the release of neurotransmitters in the brainstem and modulating brain networks related to the control of mood.
In addition, the device transfers mild electrical pulses to the brainstem through six branches of the occipital and trigeminal nerves, which are responsible for sensation in the face, ears and scalp.
Part of a digital therapeutics platform, Relivion DP enables physicians to remotely monitor patients, analyse their data and personalise treatments, using a dedicated smartphone app and a cloud database.
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Neurolief chairman Chris Richardson said: “Gaining FDA recognition of our potential to substantially impact an area of unmet need bolsters our upcoming Relivion DP Major Depression pivotal study and brings us one step closer to reaching people who desperately need this new treatment.
“This categorisation is a major milestone for Neurolief, and we hope to one day make a significant difference for patients suffering from depression.”
According to the company, 90% of patients with MMD who had not sufficiently responded to previous pharmaceutical treatment showed improvement in depression rating when using Relivion DP in an open-label clinical study.
The study, which used the Hamilton Depression Rating Scale (HDRS), also found that 37% of patients reached full remission from their depressive episodes.
Last year, Neurolief obtained the European CE-Mark to market, sell and distribute its Relivion device as a digital migraine treatment.