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30 Deep TMS™ Devices Ordered by Large Mental Health-Focused TMS Network!

BrainsWay Ltd. (NASDAQ & TASE: BWAY), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced a significant expansion of its technology platform through the recent order of 30 new Deep Transcranial Magnetic Stimulation (Deep TMS™) systems for the treatment of the major depressive disorder (MDD) by a large TMS network of clinics based in the Western and Central United States. Several of the systems also include an H7 Coil, thus enabling obsessive-compulsive disorder (OCD) treatment capability.

During the first quarter of 2023, BrainsWay shipped a net total of 48 Deep TMS™ new systems, bringing BrainsWay’s total Deep TMS installed base to 932 total systems as of March 31, 2023, an 18% increase from the installed base at the same point in the prior year. BrainsWay has installed 453 obsessive-compulsive disorder (OCD) coils as add-on helmets to almost 50% of its total installed base.

BrainsWay is excited to partner with this growing key network customer, a leading large TMS provider in the Western and Central U.S. We are committed to bringing relief to those suffering from treatment-resistant MDD and OCD,” said Hadar Levy, Chief Executive Officer of BrainsWay. “Each Deep TMS device that becomes available to patients helps further BrainsWay’s mission to improve health and transform lives, and we are committed to ensuring that no community is deprived of access to our unique therapeutic solution.”

The large TMS network that placed this order opened its first Deep TMS center in the mid-2000s in the Southwestern U.S. and has now grown to nearly 20 clinics across 6 states in the western and central U.S. These clinics offer cutting-edge technology and the newest breakthrough treatments in psychiatry to help patients find the right treatments that work for them.

BrainsWay has experienced significant growth in the Canadian market in the last 4.5 years. BrainsWay currently has an install base of 20 clinics/both private clinics and hospitals across Canada with more clinics that will be opening in the very near future. Their current locations include Alberta, British Colombia, Ontario, Quebec, Saskatchewan, and most recently New Brunswick.

In March this year, BrainsWay announced the publication of an expansive post-marketing data analysis demonstrating high response and remission rates for depression and anxious depression patients undergoing Deep Transcranial Magnetic Stimulation (Deep TMS™) treatment. The data, published in Psychiatry Research, showed the substantial benefits of Deep TMS treatment for depression, with patients who had received 30 or more treatments achieving an 82% response rate and a 65% remission rate.

BrainsWay is pleased to share this real-world evidence on Deep TMS, as it further validates the immense potential of this treatment in addressing the global mental health crisis,” said Hadar Levy, Chief Executive Officer of BrainsWay. “The average patient in this data analysis had already failed more than seven medication trials in their lifetime, and it is exciting to see that patients undergoing a full course of treatment achieved such significant outcomes. These results embolden us in our mission to improve health and transform lives.”

“These findings are truly notable,” said Aron Tendler, M.D., Chief Medical Officer of BrainsWay. “Keeping in mind that these are patients who have not had success with other treatment modalities, it is compelling to see that four out of five patients in real-world settings achieved at least a 50% reduction in their depression symptoms. Furthermore, nearly three out of four were found to have reached remission based on the Hamilton Depression Rating Scale, a gold standard clinician-administered measurement tool.”

In the study, BrainsWay collected an aggregate data set from 1,753 patients across 21 clinics, of which 1,351 patients met the inclusion criteria for the analysis. All patients were treated with the Deep TMS H1 Coil utilizing either a standard protocol (typically 18Hz, 20 minutes long) or a shorter intermittent theta burst (iTBS) protocol. Outcomes were measured with clinician-based scales (HDRS-21) and/or patient self-administered questionnaires designed specifically for depression (PHQ-9, BDI-II). This analysis showed that the average patient achieved sustained response at 16 sessions, or 21 days after beginning treatment. The evidence also showed that efficacy rates were similar between the standard and iTBS protocols. Data from questionnaires that are not specific to depression, and thus less relevant for assessing depression changes, were intentionally excluded.

About Major Depressive Disorder and Anxious Depression

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. 60-90% of depression patients also exhibit comorbid moderate to severe anxiety, a condition commonly referred to as anxious depression. These anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the recent COVID pandemic.

About OCD

More than 2 million adults in the United States suffer from obsessive-compulsive disorder (OCD). It is a severe, chronic psychiatric disease characterized by a pattern of obsessive thoughts and compulsive repetitive behaviors, which has a significantly destructive effect on patients’ day-to-day activities. Current treatment options include SSRI antidepressant medications, which must be given at very high doses for OCD patients, cognitive-behavioral treatment (CBT), or a combination of these treatment options. OCD is very difficult to treat since many patients do not respond to pharmacologic or CBT treatment, and many have difficulty tolerating the side effects of the pharmacological treatment.

 

About BrainsWay

BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. BrainsWay 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. BrainsWay 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.

Contacts:
BrainsWay:
Ido Marom
Chief Financial Officer
Tel: 844-386-7001 ext. 5
Ido.Marom AT BrainsWay.com

Investors:
Brian Ritchie
LifeSci Advisors
Tel: 646-889-1200
britchie AT lifesciadvisors.com

Media Contact:
Chris Boyer
Tel: 978-677-1777
chris.boyer AT brainsway.com

Source: GLOBE NEWSWIRE June 2023

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