TAMPA, Fla. & NETANYA, Israel--(BUSINESS WIRE)--Neurolief, an Israel-based company pioneering neuromodulation for the treatment of chronic neurological and neuropsychiatric disorders, and NeuroFront, a clinical stage biotech company focusing on innovative neuroscience therapies, jointly announced an exclusive licensing agreement for NeuroFront to develop and commercialize Relivion, non-invasive medical devices for the treatment of migraine and depression, in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.

�With 90 million people suffering from migraine and nearly 50 million suffering from depression in Greater China and South Korea, we believe this collaboration with NeuroFront is critical to our mission of helping patients globally,� stated Neurolief Chairman Chris Richardson. �We are confident that the NeuroFront team�s compelling expertise will accelerate the development and commercialization of Relivion in key Asian markets.�

Relivion is a non-invasive brain neuromodulation device that is placed around the head and delivers stimulation to the occipital and trigeminal nerves. This creates a cumulative effect by releasing neurotransmitters in the brainstem and modulating brain networks associated with control of pain and mood. The device is designed to be used at home, and to share treatment data with each patient�s physician, in addition to uploading the data to the cloud database through a dedicated app. It is also designed to self-learn and analyze the treatments using AI technology in order to optimize the treatments for patients according to their symptoms.

�Because of our commitment to developing the most innovative and effective neuroscience therapies to improve the lives of patients in Asia, NeuroFront is very excited to partner with Neurolief to bring Relivion to the many patients in Greater China and South Korea suffering from migraine and depression,� commented June Yan, co-founder and CEO of NeuroFront.

Relivion has received both FDA clearance and CE mark for the treatment of migraine. The FDA marketing clearance is based on the results of a multi-center, prospective, randomized, double-blind, placebo-controlled clinical study. Forty-six percent (46%) of the patients in the active group reached complete pain freedom compared to only 11.8% of patients in the control group. Seventy five percent (75%) of patients in the active group reached complete freedom of �Most Bothersome Symptom� (MBS, which is defined as either phonophobia, photophobia, or nausea) within 2 hours following treatment, compared to 46.7% in the control group. Complete freedom of migraine symptoms (freedom from pain as well as freedom from MBS) at 2 hours after treatment was significantly higher in the active group than in the control group (47.2% vs. 11.1%). Pain relief was also significantly higher in the active group than in the control group at 2 hours after treatment (60% vs. 37%). No serious adverse events were reported. Patients started using either the Relivion or a �placebo� device with lower treatment intensity, at the onset of their migraine episode for up to one hour. Patients were able to treat several migraine episodes during the course of the trial. The study, RIME, was conducted at leading medical centers in the US and Israel and evaluated the safety and efficacy of the device with 131 patients who met the International Classification of Headache Disorders (ICHD-3) criteria of migraine with or without aura.

Relivion has also been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) for major depression disorder. Neurolief will begin a multi-center pivotal trial of Relivion in depression called the MOOD trial, starting in the fall of 2021.

�We are grateful to have Neurolief�s trust and partnership as we, at Pivotal, are deeply committed to identifying and bringing meaningly innovative treatments, such as Relivion, to underserved patients in China and beyond,� added Dianna Qian, partner of Pivotal BioVentures China and chairman of NeuroFront.

About Neurolief

Dedicated to bringing relief to patients suffering from chronic neurological and neuropsychiatric disorders, Neurolief is creating a digital therapeutics platform of wearable clinically proven neuromodulation solutions. This technology, which is made to be worn like a headset, is intended to offer safe, highly effective treatment options that work with current pharmaceutical therapies or may provide an alternative to these therapies. It is designed to concurrently neuromodulate major neural pathways in the head, thereby affecting brain regions that are involved in the control and modulation of pain and mood. Neurolief�s technology is currently being utilized for patients with migraine and being studied for patients with major depression. The company plans to pursue investigation of additional indications in the future, such as Insomnia, ADHD and additional chronic pain and neuropsychiatric disorders. The company is based in Israel, with US operations in Tampa, FL and is made up of highly experienced professionals with a proven track record in neurosciences, neuromodulation technology and the neurotech devices industry. For more information, please visit www.neurolief.com.

About NeuroFront

NeuroFront is a China-based clinical stage neuroscience biotech company with a focus on developing and commercializing innovative neuroscience therapies to address unmet needs and improve patient�s lives in Asia. NeuroFront was established by top-tier life sciences investors and is led by an elite team of neuroscience industry veterans with substantial and compelling expertise in China and globally in both R&D and the commercialization of CNS products. For more information, please visit www.neurofrontrx.com.

About Migraine

Migraine is a common, disabling, and recurring complex neurological disorder with a genetic component, affecting adults throughout their life. It is characterized by episodic headaches that throb, intensify, and cause or co-occur with nausea, vomiting, and abnormal sensory sensitivities. As one of the most common neurologic diseases, it is estimated that in 2020, there were 90 million¹ patients in China.

About Depression

Depression is a mood disorder characterized by a depressed mood and several additional symptoms for at least 2 weeks, including decreased interest, feelings of guilt, worthlessness and/or hopelessness, fatigue, disturbances in sleep, suicidal thoughts, etc., causing significant impairment in daily life. Based on the China Mental Health Survey (2012-2015)², it is estimated that China has a prevalent depression patient base of 48 million.

References

1) Yu, S. et al. (2012). The prevalence and burden of primary headaches in China: a population-based door-to-door survey. Headache, 52(4):582-91. https://doi.org/10.1111/j.1526-4610.2011.02061.x.

2) Huang, Y. et al. (2019). Prevalence of mental disorders in China: a cross-sectional epidemiological study. Lancet Psychiatry, (3):211-224. http://dx.doi.org/10.1016/S2215-0366(18)30511-X.

Contacts

Megan Eckerman

[email protected]