This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
Since receiving De Novo clearance from FDA in August 2018, the Company has shipped OCD coils to 100 sites across the U.S.
JERUSALEM and HACKENSACK, N.J., June, 24 2019 – BrainsWay Ltd. (NASDAQ & TASE:BWAY) (BrainsWay” or the “Company”), a commercial stage medical device company focused on the development and sale of non-invasive neuromodulation products using the Company’s proprietary Deep Transcranial Magnetic Stimulation system (Deep TMS) technology for the treatment of major depressive disorder (MDD) and obsessive-compulsive disorder (OCD), today announced the shipment of the 100th Deep TMS helmet for the treatment of OCD in adults since receiving De Novo clearance from the U.S. Food and Drug Administration for this indication in August 2018.
Yaacov Michlin, President and Chief Executive Officer of BrainsWay, said, “The shipment of our 100th OCD coil represents an important milestone for BrainsWay. Our Deep TMS technology is the only TMS product currently available for OCD patients, and the shipment of OCD helmets to 100 locations across the U.S. allows us to access a large and growing number of patients who are in desperate need of a non-invasive, safe and effective treatment option. Moreover, this key achievement is indicative of the substantial physician demand that exists for additional treatment options for patients with OCD.”
Dr. Ryan Vidrine, Director of OCD program at TMS Health Solutions, said, “OCD is a devastating and debilitating mental health disorder. Integrating the Deep TMS system into my practice has allowed me to further help many OCD patients find relief from the intrusive OCD symptoms they suffer from daily.”
Dr. Geoffrey Grammar, Chief Medical Officer of Greenbrook TMS, added, “By receiving and utilizing BrainsWay’s Deep TMS technology for OCD, we have been able to provide our patients with a novel approach to symptom relief, ensuring they receive the very best care possible.”
BrainsWay’s Deep TMS system is a best-in-class device designed to maximize electromagnetic stimulation of deep and broad brain regions. BrainsWay’s Deep TMS technology differs from that of other focal TMS devices in that it is a platform solution that can directly and indirectly stimulate areas of the brain safely and efficiently at a greater depth and breadth than any other commercially available TMS device. BrainsWay’s proprietary TMS system now directly targets areas of the brain previously unreachable by other devices on the market, allowing it to be used to effectively treat OCD.
More than 2 million adults in the United States suffer from obsessive-compulsive disorder (OCD). It is a severe, chronic psychiatric disease characterized by a pattern of obsessive thoughts and compulsive repetitive behaviors, which has a significantly destructive effect on patients’ day-to-day activities. Current treatment options include SSRI antidepressant medications, which must be given at very high doses for OCD patients, cognitive-behavioral treatment (CBT), or a combination of these treatment options. OCD is very difficult to treat since many patients do not respond to pharmacologic or CBT treatment, and many have difficulty tolerating the side effects of the pharmacological treatment.
BrainsWay is a commercial stage medical device company focused on the development and sale of non-invasive neuromodulation products using the Company’s proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) technology for the treatment of major depressive disorder (MDD) and obsessive-compulsive disorder (OCD), for which Brainsway received marketing authorization from the U.S. Food and Drug Administration (FDA) in 2013 (for MDD) and in August 2018 (for OCD). BrainsWay is currently conducting clinical trials of Deep TMS in other psychiatric, neurological and addiction disorders, including smoking cessation and post-traumatic stress disorder, and is planning trials for opioid addiction, fatigue in multiple sclerosis (MS) and post-stroke rehabilitation.