Distributive policy

BrainsWay Announces Blue TOC Positive Hedging Policy

BURLINGTON, Mass. and JERUSALEM, June 21, 2022 (GLOBE NEWSWIRE) — BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced non-invasive neurostimulation treatments for mental health disorders, today announced that Highmark Blue Cross Blue Shield (BCBS) has issued a positive coverage policy applicable to the BrainsWay Deep TMS™ system for the treatment of obsessive-compulsive disorder (OCD), effective May 2, 2022. Highmark BCBS covers 6.8 million members in New York, Pennsylvania , of West Virginia and Delaware, and is the fourth largest BCBS health plan in the United States. Highmark BCBS’ parent company, Highmark Health, serves 40 million Americans in all 50 states, and the Highmark Health business is the nation’s third-largest integrated health care delivery and financing system.

A positive coverage policy applicable to Deep TMS was previously issued by Health Care Service Corporation, another large independent licensee of the BCBS Association, which covers approximately 17 million members in five states.

“We are delighted to receive this additional BCBS coverage policy for OCD from Highmark BCBS, one of the largest BCBS health plans in the United States,” said Christopher von Jako, Ph.D., President and Chief Executive Officer. the direction of BrainsWay. “This positive policy brings the total number of lives eligible for Deep TMS OCD coverage to nearly 70 million, a critical reimbursement achievement for our business. The policy is backed by a large body of compelling clinical evidence demonstrating the significant benefits OCD patients derive from treatment with our innovative Deep TMS technology, and we will continue our work to drive further positive coverage developments in this important indication. from additional BCBS systems and other major health plans.

BrainsWay remains the only TMS company to have obtained FDA clearance for the treatment of OCD based on positive clinical data from a pivotal study conducted on its own device. The Company has engaged most major commercial and government payors in a concerted process to expand TOC reimbursement and believes that over time other payors will adopt TOC coverage for Deep TMS.

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.

About BrainsWay
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 gain three FDA-approved indications, backed by pivotal 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.

Forward-looking statement
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. . In addition, 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 light of further research or otherwise. 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.

Scott Areglado
[email protected]

Bob Yedid
LifeSci Advisors
[email protected]