BrainsWay announces significant private insurance coverage from Cigna Corporation for OCD with Deep TMS™

minds way

minds way

Cigna® Issues Favorable Policy for Deep TMS for Treatment of Drug-Resistant OCD

Burlington, MA and Jerusalem, Israel, September 14, 2022 (GLOBE NEWSWIRE) – BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation therapies Cigna Corporation today announced Cigna’s announcement of positive coverage of deep transcranial magnetic stimulation (TMS) for the treatment of obsessive-compulsive disorder compulsive disorder (OCD). Cigna, one of the largest medical insurance companies in the United States, provides commercial health coverage to nearly 17 million members in 13 states, has 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, resulting in more than 86 million adults gaining access to BrainsWay’s groundbreaking Deep TMS™ OCD treatment.

“Creating this positive OCD coverage also facilitates BrainsWay’s ability to leverage its leadership role in advancing treatment for this debilitating condition,” said Christopher von Jako, PhD, president and CEO of BrainsWay. “Importantly, the ongoing reimbursement momentum of deep TMS is leading to increased access to our unique treatment that is critical to our mission to improve health and transform the lives of those with disorders with limited treatment options.”

Cigna will issue an updated revision of its TMS coverage policy effective September 15, 2022 to extend coverage to patients 18 years of age or older who have been diagnosed with OCD. Under the revised policy, a 30-36 TMS initial therapy session regimen will be categorized as medically necessary after two or more drug trials and an evidence-based psychotherapy trial have failed without significant improvement in symptoms. Patients who have experienced a 30% or greater improvement in their Yale-Brown OCD scale (Y-BOCS) for at least 2 months will also be candidates for an additional 30-36 session regimen.

“This achievement is further acknowledgment of the significant efforts contributed by the lead investigators in the pilot and pivotal trials of Deep TMS, clinicians in the field who treat today OCD patients, and BrainsWay partners dedicated to expanding access and awareness of this life-changing experience,” said Aaron Tendler, MD, chief executive officer. Clinicians at BrainsWay.” OCD is a difficult disease to treat, and nearly half of OCD patients resist treatment. BrainsWay continues to lead in this field, and remains the only TMS company to demonstrate clinical efficacy in the treatment of OCD with randomized, placebo-controlled data.”

BrainsWay’s patented H7 Coil is designed to penetrate the deeper and broader structures of the brain associated with OCD. The company’s Deep TMS system was granted De Novo clearance by the US Food and Drug Administration (FDA) for the treatment of OCD in late 2018 and has been fully released to the market in 2019. As of June 30, 2022, 368 OCD files have been shipped as additional helmets to accompany BrainsWay Platform Systems. Approximately 45% of all BrainsWay systems in this area have an H7 coil.

“The economic burden on the US healthcare system for OCD treatments is over $10.6 billion annually, and we are excited that Cigna’s leadership in medical and behavioral health has recognized the value we can provide to these patients,” said Scott Blackman, director of market access at Cigna. . minds way. “This positive coverage decision complements the growing body of compelling clinical evidence supporting the treatment of OCD with our Deep TMS H7 profile.”

About obsessive-compulsive disorder
Obsessive-compulsive disorder (OCD) is a chronic and debilitating condition with a lifetime prevalence in the United States of 2.3%. Obsessive-compulsive disorder is characterized by recurring, uncontrollable thoughts (obsessions) and behaviors (compulsions) that the patient feels compelled to repeat over and over, and is considered one of the top 10 debilitating medical conditions associated with decreased quality of life and loss of income by the World Health Organization (WHO). Due to the complexity and heterogeneity of the condition, along with the high percentage of drug-resistant patients, many patients with OCD do not respond well to first treatment options. The economic burden on the US health care system for OCD treatments is estimated to be more than $10.6 billion annually.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive neurostimulation therapies for mental health disorders. The company is boldly advancing neuroscience with its Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology to improve health and transform lives. BrainsWay is the first and only TMS to have three FDA approved indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reducing anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The company is dedicated to leadership through superior science and building on an unparalleled body of clinical evidence. Additional clinical trials of deep TMS are underway in various psychiatric, neurological, and addiction disorders. Founded in 2003, with offices in Burlington, Massachusetts and Jerusalem, Israel, BrainsWay is committed to increasing the global awareness and broad reach of Deep TMS. For the latest news and information about BrainsWay, 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,” “expects,” “projects”, “expects”, “estimates”, “objectives”, “believes”, “hopes”, “potential” or similar words. These forward-looking statements and their implications are based solely on the current expectations of the Company’s management and are subject to a number of factors and uncertainties that may cause In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results will suggest similar conclusions or that historical results referred to herein will be similarly interpreted in light of additional or other research The following factors, among others, could cause actual results to differ materially from those shown in the forward-looking statements: inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in initiating and/or completing studies and successfully planned clinical trials; Failure to obtain approvals by regulatory agencies for the company’s expected time frame, or at all; Inability to retain or attract key personnel whose knowledge is essential for Deep TMS product development; Unforeseen difficulties with deep TMS products and processes, and/or inability 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 the intellectual property licensed to the Company; possibility of product liability; Changes in applicable legislation, rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; Inadequate or late payment from third party payers, including insurance and Medicare companies; the inability to market Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; Inability to develop and introduce new technologies, products and applications in a timely manner, which could cause actual results or the Company’s performance to differ materially from those contemplated by such forward-looking statements.

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 revise 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 under the heading “Risk Factors” in the Company’s filings with the US Securities and Exchange Commission.

Contacts:

Minds way:
Scott Argalado
Senior Vice President and Chief Financial Officer
Scott.Areglado@BrainsWay.com

Investors:
Bob Hand
LifeSci . Consultants
646-597-6989
Bob@LifeSciAdvisors.com

Media contact:
Megan Lasca
(610) 212-0125
Meghan.Laska@BrainsWay.com

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