Additional data on first non-invasive medical device cleared by the FDA for OCD demonstrated that 73% responded positively to Deep TMS, and showed durability of therapeutic effect
Results to be Utilized in Company’s Efforts to Secure Reimbursement in OCD
CRESSKILL, N.J. and JERUSALEM, Israel, November 11, 2020 (GLOBE NEWSWIRE) – BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in the advanced, non-invasive treatment of brain disorders, today announced the publication of new positive data from a post-marketing study at 22 clinical sites patients suffering from obsessive-compulsive disorder (OCD) in the Journal of Psychiatric Research.
The patients were treated with BrainsWay’s proprietary H7-coil deep transcranial magnetic stimulation (Deep TMS) system, the first non-invasive medical device cleared by the U.S. Food and Drug Administration (FDA) for OCD. The primary outcome measure was response, defined by at least a 30% reduction in the Yale Brown Obsessive Compulsive Scale (Y-BOCS) score from baseline to endpoint. The data showed that 58% of those who completed the full 29-session course of therapy achieved response. In addition, 73% of patients, including those who did and did not complete the full course of therapy, demonstrated response at least once prior to the conclusion of treatment. Furthermore, a secondary endpoint of the study showed that 52% of patients demonstrated sustained response for at least one month following treatment, thereby showing that the therapeutic effect from Deep TMS can be maintained for weeks.
“It is gratifying to see the real-world utility and efficacy of Deep TMS for OCD under clinical conditions,” stated Aron Tendler, M.D., Chief Medical Officer of BrainsWay. “This important study was conducted in 219 patients at 22 centers across the U.S., and we believe these compelling results are indicative of the benefit this innovative technology can have on patients within a practical treatment setting.”
“We are thrilled with the results of this post-marketing study and continue to view Deep TMS as an important treatment option for patients suffering from OCD,” added Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “We view the publication of these data in the prestigious Journal of Psychiatric Research as further validation of BrainsWay’s leadership position in TMS. Importantly, we intend to leverage these compelling results with payors in our efforts to secure reimbursement for Deep TMS in OCD.”
OCD is a chronic and disabling disorder that affects about 2.3% of the U.S. population in their lifetime, or an estimated 1.2% of adults per year. The BrainsWay Deep TMS system provides patients suffering from this hard-to-treat disease with hope through a non-invasive treatment option that augments existing OCD therapeutic approaches, such as medication, psychotherapy and cognitive-behavioral therapy(CBT).
BrainsWay received De Novo clearance for the treatment of OCD from the FDA in 2018, following positive results from a randomized, placebo-controlled multicenter clinical trial.
More About the Study
BrainsWay collected real-world clinical treatment data from 219 patients as part of an ongoing post-marketing study. OCD patients were treated with BrainsWay’s H7 Deep TMS coil as an adjunct to other forms of treatment, and clinical outcomes were assessed using the Y-BOCS score, the gold standard in the field. Prior to each treatment session, patients underwent 3-5 minutes of individualized symptom provocation to activate their OCD circuitry. The primary endpoint was response at 29 treatment sessions, which was the same protocol used in BrainsWay’s previous pivotal multicenter study which led to FDA clearance. No significant adverse events relating to the treatment were reported.
More About OCD
More than 2.5 million adults in the United States suffer from OCD every year. It is a chronic psychiatric illness 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 high dosages of SRI antidepressant medications (Clomipramine, Fluoxetine, Sertraline, Paroxetine and Fluvoxamine), a form of CBT called exposure and response prevention (ERP), or a combination of these treatment options. OCD is very difficult to treat since many patients do not respond or tolerate medications and ERP. OCD is usually comorbid with other conditions (such as depression or bipolar disorders), making the patient effectively treatment resistant and increasing the illness and treatment burden. As many as 1 in 2 OCD patients have suicidal thoughts, 1 in 4 will attempt suicide in their lifetime, and the risk of completed suicide is ten times higher with OCD than without.
BrainsWay is a commercial stage medical device company focused on the development and sale of non-invasive neurostimulation products using the Company’s proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) platform technology. The Company received marketing authorization from the U.S. Food and Drug Administration (FDA) for its products for a variety of patient populations, including in 2013 for patients with major depressive disorder (MDD), in 2018 for patients with obsessive-compulsive disorder (OCD), and in 2020 for patients with smoking addiction. BrainsWay is currently conducting clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders. To learn more, please visit www.brainsway.com
Forward Looking Statements
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. Moreover, the data in this press release results from a real-world post marketing study of different patient groups treated under disparate conditions. By its very nature, this data is not blinded, the results as presented involve extrapolations from different data sets without necessarily distinguishing between primary and secondary endpoints, and the data was not reviewed by the US Food and Drug Administration and could be subject to different statistical analyses which could impact the results as expressed herein. 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; 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, and the effect of the global COVID-19 health pandemic on our business and continued uncertainty and market impact relating thereto.
Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company’s filings with the U.S. Securities and Exchange Commission.
SVP and Chief Financial Officer