BURLINGTON, Mass. and JERUSALEM, Israel, Sept. 14, 2022 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that Cigna Corporation has announced positive coverage applicable to the deep transcranial magnetic stimulation (TMS) for the treatment of obsessive-compulsive disorder (OCD). Cigna, one of the largest medical insurance companies in the United States, provides commercial medical coverage to approximately 17 million members in 13 states, offers Medicare Advantage plans in 16 states, and participates in the health insurance market .© online exchange. With this new policy, Cigna joins the ranks of Centene, Highmark, Health Care Services Corporation, Blue Cross Blue Shield, Tricare and Palmetto GBA Medicare, enabling more than 86 million adults to now have access to the pioneering Deep treatment. TMS™OCD from BrainsWay.
“Building this positive coverage for OCD further facilitates BrainsWay’s ability to capitalize on its leadership role in advancing the treatment of this debilitating disease,” said Christopher von Jako, PhD, President and Chief management of BrainsWay. “Most importantly, Deep TMS’s continued reimbursement momentum translates into increased access to our unique therapy that is critical to our mission to improve health and transform the lives of people with disorders with limited treatment options. .”
Cigna will release an updated revision to its TMS medical coverage policy effective September 15, 2022, extending coverage to patients age 18 and older diagnosed with OCD. Under the revised policy, an initial regimen of 30 to 36 TMS treatment sessions will be classified as medically necessary after two or more drug trials and one trial of evidence-based psychotherapy have failed without significant improvement in symptoms. Patients with a 30% or greater improvement in their Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) sustained for at least two months would also be candidates for an additional 30-36 session regimen.
“This achievement is further recognition of the substantial efforts made by principal investigators in pilot and pivotal trials of Deep TMS, clinicians in the field who treat OCD patients today, and BrainsWay partners dedicated to the expanding access and awareness of life-changing treatment,” said Aron Tendler, MD, Chief Medical Officer of BrainsWay. “OCD is a difficult disease to treat, and nearly half of patients with OCD are treatment resistant BrainsWay continues to be a pioneer in the field and remains the only TMS company to have demonstrated clinical efficacy in the treatment of OCD through randomized, placebo-controlled data.
BrainsWay’s patented H7 coil is designed to penetrate the deeper and broader brain structures associated with OCD. The Company’s Deep TMS system received De Novo clearance from the U.S. Food and Drug Administration (FDA) for the treatment of OCD in late 2018 and launched for full commercialization in 2019 As of June 30, 2022, 368 reels of TOC have been shipped. as additional headsets to accompany BrainsWay platform systems. About 45% of all BrainsWay systems in the field have an H7 coil.
“The economic burden on the US healthcare system for OCD treatments is more than $10.6 billion annually, and we are delighted that Cigna’s leadership in medical and behavioral health has recognized the value we can offer these patients,” said Scott Blackman, director of market access at Brains Way. “This positive coverage decision complements the growing body of compelling clinical evidence supporting the treatment of OCD with our Deep TMS H7 coil.”
About Obsessive-Compulsive Disorder
Obsessive-compulsive disorder (OCD) is a chronic, debilitating disease with a lifetime prevalence in the United States of 2.3%. Characterized by uncontrollable, recurring thoughts (obsessions) and behaviors (compulsions) that the sufferer feels compelled to repeat over and over again, OCD is considered by the World Health Organization (WHO) to be one of the top 10 debilitating medical conditions associated with decreased quality of life and loss of income. Due to the complexity and heterogeneity of the disease, coupled with the high percentage of drug-resistant patients, many patients with OCD do not respond well to first-line treatment options. The economic burden on the US healthcare system for OCD treatments is estimated at more than $10.6 billion annually.
BrainsWay is a world leader in advanced non-invasive neurostimulation treatments for mental health disorders. The company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-approved indications supported by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxiety depression), obsessive-compulsive disorder, and tobacco addiction. The company is committed to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological and addictive disorders are ongoing. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness and access to Deep TMS. For the latest BrainsWay news and information, please visit www.brainsway.com.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be prefaced by the words “intends”, “may”, “will”, “expects”, “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 Company’s management 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. . Further, historical results or the conclusions of 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 in the same way in light of additional research or other. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: insufficient financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in initiating and/or completing planned clinical studies and trials; failure to obtain regulatory approvals within the Company’s timelines, or at all; failure 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 failure to develop necessary improvements; 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 applicable laws and rules and regulations; adverse market perception and acceptance of Deep TMS technology; insufficiency or delays in reimbursement by third-party payers, including insurance companies and Medicare; inability to market Deep TMS, including internationally, by the Company or through third-party distributors; development of products by competitors; failure to develop and introduce new technologies, products and applications on a timely basis, which could cause the Company’s actual results or performance to differ materially from those contemplated in such forward-looking statements.
Any forward-looking statements in this press release speak 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 required by applicable securities laws. More detailed information about the risks and uncertainties affecting the Company can be found under the heading “Risk Factors” in the Company’s filings with the United States Securities and Exchange Commission.
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