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Jerusalem-based BrainsWay has achieved impressive marketing successes resulting in record revenue growth. BrainsWay could start even  making a profit by next year.

In the third quarter, BrainsWay achieved a positive adjusted EDIDA with cash flow from operations exceeding $1 million. BrainsWay shipped a net total of 56 Deep TMS™ new systems during the third quarter of 2023, bringing BrainsWay ’s total Deep TMS installed base to 1,041 total systems as of September 30, 2023, a 22% increase from the total installed base at the same point in the prior year.

“Our third quarter revenues of $8.3 million represent an increase of 61% year-over-year, reflecting the strong and growing demand for our innovative Deep TMS technology,” said Hadar Levy, BrainsWay ’s Chief Executive Officer. “Our increasingly robust sales pipeline continues to pay off, securing multi-system contracts with large networks in the U.S. as well as continued momentum internationally in various countries including Taiwan, India, and Korea.”

“Importantly, our third quarter operating results included nearing breakeven operating income, achieving positive Adjusted EBITDA ahead of schedule, and generating cash flow from operations exceeding $1 million – all of which were driven by our revenue growth and the cost optimization measures we executed on earlier this year,” continued Mr. Levy. “We are now targeting positive operating income and increased Adjusted EBITDA for the fourth quarter of 2023 while demonstrating full-year revenue growth over 2022.”

BrainsWay partnered with Unison Healthcare Group to strategically enhance access and awareness of Deep TMS in the Taiwanese market. BrainsWay recently delivered 16 Deep TMS systems to Taiwan, with another 5 systems planned for installation before the end of the year.

“There are approximately 1.5 million patients suffering from depression in Taiwan. For those individuals that are resistant to other therapies, Deep TMS represents a unique non-drug option to alleviate the symptoms of this serious mental health condition,” said Shih Wei-Lun, Unison Healthcare Group’s Chief Executive Officer.

In India, after the recent multisystem orders this summer, Asha Neuromodulation Clinics (ANC) and its affiliates will own 25 BrainsWay Deep TMS systems.

“At Asha Neuromodulation Clinics, we understand the challenges of leading a fast-paced life and the need for better outcomes in mental health care delivery,” said Dr. M.S. Reddy, Director of Asha Neuromodulation Clinics. “That is why we are working with BrainsWay to offer the most advanced therapeutic solution available in the industry throughout the country, including at our new flagship clinic in Gachibowli, as well as at Asha Hospitals in Hyderabad, Bengaluru, Vizag, Mysuru, Vijayawada, Guntur, Chandigarh, and New Delhi.”

BrainsWay also has distribution agreements for Deep TMS in Thailand and Singapore.

BrainsWay received an order for an additional 10 Deep TMS systems from Katie’s Way, an American non-profit mental health services provider serving U.S. active duty military members, veterans, and their families. This will bring them to a total of 20 systems. Katie’s Way was founded by Jeff Mathis, following the loss of his daughter, Katie, in her battle with depression. Their mission is to cure 80 % of military patients who suffer from depression and anxiety, with two years+ remission through the delivery of TMS Therapy enabling increased readiness, retention & well-being.

Katie’s Way was founded in memory of my daughter, Katie, who tragically lost her battle with depression,” said Jeff Mathis, Founder of Katie’s Way. “Our goal is to ensure that no other family needs to endure such pain. These additional BrainsWay systems will allow us to extend our reach, offer hope, and ultimately save lives.”

In November, a major private insurer in Louisiana joined the growing list of payors reducing the patient eligibility requirements for transcranial magnetic stimulation (TMS) treatment from four failed medication trials to two.

BrainsWay ‘s Deep Transcranial Magnetic Stimulation (Deep TMS™) technology has recently become available in South Korea. After growing momentum over the past few years, recent sales are expected to bring BrainsWay ’s installed base in the country to over 20 Deep TMS systems.

Deep Transcranial Magnetic Stimulation, or Qeep TMS, is an FDA-approved, non-invasive treatment option that offers long-term relief for major depression, OCD, anxiety and PTSD.

Antidepressant medication trials often require weeks or months to determine if they are benefiting patients struggling with depression, the main cause of disability worldwide. Thus, policy changes that reduce prior medication failure requirements enable significantly quicker access to depression relief for many treatment-resistant patients. In a recent post-marketing analysis of 1,753 subjects, Deep TMS was shown to reduce depression symptoms by 50% or greater in four out of five depression patients, and two out of three patients achieved remission.

Recently, the Clinical TMS Society (CTMSS), an influential medical society dedicated to supporting clinical practice, research, and access to transcranial magnetic stimulation (TMS), has published the first coverage recommendations for smoking addiction treatment using TMS. Currently, BrainsWay Deep TMS™ is the only TMS technology to have received FDA clearance for the treatment of smoking addiction. With this new coverage guidance for insurers, CTMSS now recommends TMS coverage for individuals with a confirmed diagnosis of Tobacco Use Disorder (TUD) who failed two alternative treatment methods, cannot tolerate drugs, or have other comorbid medical conditions (secondary to TUD) such as COPD, artery disease and lung cancer.

“We are encouraged by the ongoing efforts of the Clinical TMS Society to drive favorable coverage for TMS around the world,” said Aron Tendler, MD, Chief Medical Officer of BrainsWay . “Nicotine use continues to be the leading cause of preventable death across the globe, and based our data, Deep TMS can be a beneficial solution for those looking to quit without prior success.”

Results from BrainsWay ’s pivotal randomized controlled trial published in 2021 demonstrated that over one in four highly addicted cigarette smokers receiving Deep TMS treatment quit during the study, two in three quitters maintained their abstinence during the follow-up period, and the average number of cigarettes smoked per week among the overall active patient group was significantly reduced by 75%.

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. 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
844-386-7001 ext. 5
Ido.Marom AT Brainsway.com
Investors:

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

Media Contact:
Chris Boyer
844-386-7001 ext. 2
Chris.Boyer AT Brainsway.com

 

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