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 (GLOBE NEWSWIRE) -- 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.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials or in receiving positive top-line or final study results; failure to obtain approvals by regulatory agencies on the Company’s anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company’s intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in BrainsWay Ltd.'s periodic filings with the U.S. Securities and Exchange Commission.