Neurolief

Neurolief is a medical technology company established in 2013, focusing on the neurotechnology sector. The company was founded by Amit Dar and Shmuel Shany. Dar, who serves as the CTO, is an experienced entrepreneur with a background in neuromodulation, having previously held senior R&D roles at Bioness Neuromodulation and NESS, where he contributed to the development of technologies used by hundreds of thousands of patients.

The company operates in the digital therapeutics market, developing non-invasive brain neuromodulation systems to treat neurological and neuropsychiatric disorders. Neurolief's business model appears to be a mix of B2B and B2B2C, targeting healthcare providers, pharmaceutical companies, and patients. Its primary product, Relivion®, is a wearable headset designed for at-home patient use. This device functions by delivering mild electrical pulses to stimulate six branches of the trigeminal and occipital nerves, which are involved in pain and mood regulation. This method of concurrent stimulation of multiple nerve pathways is a distinct feature of the Relivion system.

The Relivion® system is prescription-based and connects to a mobile application that allows patients to track treatments and share data with their physicians. This cloud-connected platform enables remote monitoring and the potential for personalized therapy adjustments over time, with future iterations planned to incorporate AI and machine learning. The company generates revenue through the sale and distribution of this device. A significant milestone for Neurolief was achieving FDA clearance in March 2021 for the acute treatment of migraine in adults, based on positive results from its pivotal RIME clinical trial. The device also received its European CE Mark in 2019 and was approved in Japan in January 2024, where it is commercialized in partnership with Sawai Pharmaceutical Co., Ltd. Beyond migraine treatment, Neurolief has successfully completed a pivotal study for the use of its technology in treating Major Depressive Disorder (MDD) and is now seeking regulatory approval for this indication.

Keywords: neuromodulation, digital therapeutics, migraine treatment, medical device, neurotechnology, brain stimulation, wearable tech, mental health, major depressive disorder, Relivion, non-invasive therapy, pain management, home healthcare, e-health, therapeutic devices, neurostimulation, FDA cleared, CE Mark, chronic pain, neuropsychiatric disorders, digital health