BrainsWay Receives Expanded FDA Labeling to Treat Late Life Depression
BrainsWay has announced that the FDA has expanded the indication for its Deep Transcranial Magnetic Stimulation system (Deep TMS™) to treat major depressive disorder (MDD) in patients aged 22 to 86, extending beyond the previous age limit of 68. This marks the company's 10th FDA clearance, making their Deep TMS the only TMS device approved for depression treatment in patients over 68. The expanded labeling is supported by clinical data showing significant response and remission rates in older patients. BrainsWay sees this as a promising business opportunity, given the rising life expectancy and the need for effective depression treatments in the elderly.
- Expanded FDA clearance increases target patient demographic from up to age 68 to up to age 86.
- Clinical data shows 69% response and 62% remission rates with HDRS-21 in patients over 68.
- Deep TMS is now the first and only TMS device indicated for patients over 68 with MDD.
- Opens new business opportunities in caregiving and assisted living markets.
- No mention of financial gains or immediate revenue impact from the expanded FDA clearance.
- Potential challenges in market penetration and competition in expanding to older age demographics.
Insights
The recent FDA clearance for BrainsWay's Deep TMS™ system to treat late-life depression is a major milestone in the realm of mental health treatments. This latest approval extends the age range for treatment up to 86 years, addressing a critical need for effective depression treatment options in the elderly demographic. The clinical data presented to the FDA, which showed response and remission rates of 69% and 62% respectively using the HDRS-21 scale, underscores the efficacy of Deep TMS™ in older patients. This is notable because traditional TMS systems may struggle with the increased scalp-to-brain distance in older individuals due to brain atrophy.
For a retail investor, this development enhances the credibility of BrainsWay’s technology and its ability to meet unmet medical needs. It positions the company at the forefront of noninvasive neurostimulation treatments, setting it apart from competitors who have not received such clearances. The extended age range approval effectively broadens the patient population eligible for this treatment, which can translate to increased market adoption and revenue growth.
Adding context, it's important to understand that the elderly population is growing globally and mental health concerns among this demographic are often under-addressed. The ability to provide a noninvasive, effective treatment could reduce the reliance on pharmacological therapies, which often have adverse side effects in older adults. Overall, this can lead to better health outcomes and reduced healthcare costs associated with elderly depression care.
From a financial perspective, this FDA clearance represents a significant growth opportunity for BrainsWay. The expansion of the age indication for their Deep TMS™ system means that the company can now target a larger segment of the market. Given the high prevalence of Major Depressive Disorder (MDD) among older adults and the limited effective treatment options, the demand for such innovative solutions is likely to be robust. This can potentially translate to increased sales and a stronger financial performance.
Investors should also consider the competitive advantage this provides BrainsWay. Being the first and only TMS device approved for use in patients up to 86 years old allows the company to capture market share before competitors can enter this segment. This first-mover advantage can be particularly valuable in the medical device sector, where FDA clearances are a significant barrier to entry. Moreover, the positive clinical outcomes reported, with high response and remission rates, bolster the product's marketability and adoption rates among healthcare providers.
Looking at the bigger picture, BrainsWay's ability to obtain multiple FDA clearances (this being their 10th) speaks to the robustness of their research, development and regulatory strategies. It suggests a well-established pipeline and the potential for further innovations and approvals, which could drive long-term growth. However, investors should remain attentive to the company's execution in scaling up production and distribution to meet the anticipated increase in demand.
Deep TMS™ Becomes the First and Only TMS Device Indicated for Depression Treatment in Patients Between the Ages of 68 and 86
BURLINGTON, Mass. and JERUSALEM, June 03, 2024 (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 the US Food and Drug Administration (FDA) has granted an expanded indication for the Company’s Deep Transcranial Magnetic Stimulation system (Deep TMS™) allowing for the treatment of patients with major depressive disorder (MDD) ages 22 to 86, changing the previous upper age limit of 68.
This represents the Company’s 10th FDA clearance and makes BrainsWay Deep TMS the first and only form of TMS indicated for the treatment of patients over the age of 68 suffering from MDD, including those with comorbid anxiety symptoms.
“Depression does not disappear at age 68, but as we get older, brain atrophy increases the distance from the scalp to the brain which can make it more challenging to reach and treat specific brain targets associated with depression,” stated Colleen A. Hanlon, Ph.D., BrainsWay’s Vice President Medical Affairs. “We believe that the deeper and broader stimulation of Deep TMS plays a meaningful role in overcoming these age-related, anatomical changes, and were able to present compelling clinical data to the FDA demonstrating the efficacy of Deep TMS on these older patients,” concluded Dr. Hanlon.
BrainsWay’s application to the FDA included study data showing, for example, that MDD patients over 68 years of age who were treated with the Company’s H1 Coil demonstrated
“This significant development presents an exciting business opportunity for BrainsWay,” said Hadar Levy, Chief Executive Officer of BrainsWay. “As life expectancies continue to rise, we believe there is strong, untapped interest on the part of caregivers, assisted living facilities, and families of those suffering from depression to find new, effective therapeutic solutions that can alleviate the debilitating burden imposed by this condition on our growing elderly population,” concluded Mr. Levy.
About Major Depressive Disorder
Major depressive disorder (MDD) is a common and debilitating form of depression characterized by physiological, emotional, and cognitive symptoms. According to the World Health Organization (WHO), depression affects approximately 264 million people worldwide, and the U.S. National Institute of Mental Health (NIMH) estimates that 21 million adults in the United States suffer from an MDD episode within a given year. Common symptoms of MDD include loss of interest, depressed mood, reduced energy, disturbed sleep, and changes in appetite. 60
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 clinical 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:
BrainsWay:
Ido Marom
Chief Financial Officer
Ido.Marom@BrainsWay.com
Investors:
Brian Ritchie
LifeSci Advisors
britchie@lifesciadvisors.com
Media Contact:
Ross Mitchell
Vice President of Global Marketing
Ross.Mitchell@BrainsWay.com
FAQ
What is the new age range for patients eligible for BrainsWay's Deep TMS treatment after the FDA clearance?
What are the response and remission rates for patients over 68 using BrainsWay's Deep TMS?
Why is the expanded FDA indication for BrainsWay's Deep TMS significant?
What business opportunities does the expanded FDA labeling present for BrainsWay?
