The treatment is for a major depressive disorder.
Neurolief will complete and submit a study on its Neuromodulation therapy and submit it to the FDA. The organization made the announcement after completing an analysis of the data from the still-ongoing study.
In a press release, Neurolief CEO Scott Drees said, “The successful results of this planned interim analysis are an extremely important milestone for our company. MDD is a debilitating condition of epidemic proportion with severe negative impact on patients and humanity. Making this new promising therapy available is a top priority for Neurolief. It has the potential to be life-changing for treatment resistant depression (TRD) patients whose symptoms do not sufficiently improve with antidepressant medications. We can now progress toward making Relivion®DP available to the millions of patients in desperate need."
The press release also detailed how the system works. The patient wears a device on their head which transmits mild electrical impulses. These pulses stimulate points along the brainstem to release neurotransmitters and effect areas of the brain related to mood.
The study is being carried out across 12 clinical sites in the US and one site in Israel, and it is tracking changes in depression symptoms over eight weeks.