BrainsWay Announces Positive OCD Coverage Policy from Blue Cross Blue Shield® (BCBS) Licensee Highmark BCBS for Deep TMS™

Rhea-AI Summary

BrainsWay Ltd. announces positive coverage from Highmark BCBS for its Deep TMS™ treatment of obsessive-compulsive disorder (OCD), effective May 2, 2022. This coverage benefits 6.8 million members across New York, Pennsylvania, West Virginia, and Delaware. With existing coverage from Health Care Service Corporation, nearly 70 million lives are now eligible for Deep TMS OCD treatment. BrainsWay remains the only TMS company with FDA clearance for OCD, backed by positive clinical data. The firm aims to enhance reimbursement for Deep TMS through continued engagement with major payors.

Positive

• Highmark BCBS's coverage expands eligible lives for Deep TMS OCD treatment to nearly 70 million.
• BrainsWay is the only TMS provider with FDA clearance for OCD, indicating a competitive advantage.
• Strong clinical evidence supports the efficacy of Deep TMS treatment for OCD patients.

Negative

• None.

Highmark BCBS Covers 6.8 Million Members in Four States

BURLINGTON, Mass. and JERUSALEM, June 21, 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 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 U.S. Highmark BCBS’s parent company, Highmark Health, serves 40 million Americans in all 50 states, and the Highmark Health enterprise is the third largest integrated health care 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 licensee of the BCBS Association, which covers approximately 17 million members across five states.

“We are excited to receive this additional BCBS coverage policy for OCD from Highmark BCBS, one of the largest BCBS health plans in the U.S.,” said Christopher von Jako, Ph.D., President and Chief Executive Officer 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 company. The policy is supported by the large body of compelling clinical evidence demonstrating the meaningful benefits derived by OCD patients 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 governmental payors as part of a concerted process to expand OCD reimbursement and believes that, over time, additional payors will adopt OCD coverage for Deep TMS.

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%. Characterized by uncontrollable, reoccurring 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 percentage of patients that are drug-resistant, many patients suffering from OCD do not respond well to first line treatment options. The economic burden on the U.S. healthcare system for OCD treatments is estimated to be over $10.6 billion per year.

About BrainsWay
BrainsWay is a global leader in advanced noninvasive 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-cleared indications backed 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 dedicated 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 addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. For the latest news and information about BrainsWay, 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 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. In addition, historical results or conclusions from 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 similarly in light of additional research or otherwise. 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, which could cause the actual results or performance of the Company to differ materially from those contemplated in 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 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.

Contacts:
Scott Areglado
SVP and Chief Financial Officer
617-771-2287
SAreglado@brainsway.com

Investors:
Bob Yedid
LifeSci Advisors
646-597-6989
Bob@LifeSciAdvisors.com

FAQ

What is the significance of Highmark BCBS's coverage policy for BrainsWay?

Highmark BCBS's coverage policy significantly increases the number of lives eligible for BrainsWay's Deep TMS treatment for OCD, indicating broader access and potential revenue growth.

How many members does Highmark BCBS cover?

Highmark BCBS covers approximately 6.8 million members across four states.

When did the coverage for Deep TMS OCD treatment by Highmark BCBS become effective?

The coverage for Deep TMS OCD treatment by Highmark BCBS became effective on May 2, 2022.

What percentage of the USA's OCD treatment costs does BrainsWay aim to address?

The economic burden of OCD treatments in the U.S. is estimated at over $10.6 billion per year, which BrainsWay aims to address through its Deep TMS technology.

What is BrainsWay's strategy for expanding Deep TMS coverage?

BrainsWay is actively engaging with major commercial and governmental payors to expand coverage for Deep TMS for OCD treatment.