BrainsWay announces a positive OCD coverage policy from Blue

BURLINGTON, Mass. And JERUSALEM, June 21, 2022 (GLOBE NEWSWIRE) – BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or “Company”), a global leader in advanced non-invasive neurostimulation treatments for health disorders mental health, announced today 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 the states of New York, Pennsylvania, West Virginia, and Delaware, and is the fourth largest BCBS health plan in the United States. Highmark BCBS’s parent company, Highmark Health, serves 40 million Americans in all 50 states, and the Highmark Health firm is the third largest integrated healthcare delivery and financing system in the nation.

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

“We are thrilled to receive this additional BCBS coverage for OCD from Highmark BCBS, one of the largest BCBS health plans in the United States,” said Christopher von Jako, Ph.D., President and CEO of BrainsWay. “This positive policy brings the total number of lives eligible for Deep TMS OCD coverage to nearly 70 million, a key reimbursement achievement for our company. The policy is supported by the large body of compelling clinical evidence demonstrating the significant benefits OCD patients derived from treatment with our innovative Deep TMS technology and we will continue our work to drive further positive developments in coverage in this important indication from additional BCBS systems and other important 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 device. The Company has involved most of the major commercial and government payers as part of a concerted process to expand OCD reimbursement and believes that, over time, additional payers will adopt OCD coverage for Deep TMS.

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

About BrainsWay
BrainsWay is a global leader in advanced non-invasive neurostimulation treatments for mental health disorders. The company is boldly promoting 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 studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The company is committed to leading you through superior science and building on its unmatched body of clinical evidence. Further clinical trials of Deep TMS are ongoing in various psychiatric, neurological and addictive disorders. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness and broad access to Deep TMS. For the latest news and information on BrainsWay, 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 preceded by the words “intends”, “may”, “will”, “plans”, “expects,” “expects” , “Plans”, “predicts”, “estimates”, “aims”, “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 could cause actual results to differ materially from those described in the forward-looking statements. Furthermore, historical findings or conclusions from scientific research and clinical studies do not guarantee that future results suggest similar conclusions or that the historical findings referenced herein are interpreted in a similar way in the light of further research or otherwise. The following factors, among others lters, could cause actual results to differ materially from those described in the forward-looking statements: inadequate financial resources to meet future capital requirements; changes in technology and market needs; delays or obstacles in initiating and / or successfully completing planned clinical trials and trials; failure to obtain approval from regulatory agencies on the Company’s schedule, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unexpected 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 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 delayed reimbursement by third party taxpayers, including insurance companies and Medicare; inability to market Deep TMS, even internationally, by the Company or through third-party distributors; competitive product development; failure to develop and promptly introduce new technologies, products and applications, 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 refer only to the date of this press release. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities law. More detailed information on the risks and uncertainties affecting the Company is contained in the “Risk Factors” section in the filings of the Company with the US Securities and Exchange Commission.

Contacts:
Scott Areglado
Senior Vice President and Chief Financial Officer
617-771-2287
[email protected]

Investors:
Bob Yedid
LifeSci Consultants
646-597-6989
[email protected]