BrainsWay Initiates Clinical Evaluation of Rotational Field “Deep TMS 360°™” Technology

Rhea-AI Summary

BrainsWay Ltd. (BWAY) to clinically evaluate innovative stimulation technology in two new feasibility trials. The patented 'Rotational Field' TMS aims to stimulate a greater number of neurons in the brain, potentially impacting patients with stroke and obsessive-compulsive disorder (OCD). The technology is not yet FDA-cleared, but the company aims to assess its potential clinical impact in the new studies.

Insights

Medical Research Analyst

The initiation of feasibility trials for BrainsWay's innovative 'Rotational Field' TMS technology marks a pivotal step in the advancement of neurostimulation treatments. Traditional Transcranial Magnetic Stimulation (TMS) methods have limitations in the scope of neuron activation, which the Rotational Field system aims to overcome by stimulating a broader array of neural orientations. The potential to enhance neural activation could lead to significant improvements in treatment outcomes for mental health disorders and neurological conditions like stroke and OCD.

The clinical impact of such technology, if proven effective and safe, could disrupt the current TMS market by offering a more efficient and potentially more effective treatment option. This could result in an increased demand for BrainsWay's technology, potentially expanding its market share and positively affecting its financial position in the long-term. Moreover, the ability to shorten the standard treatment protocol could reduce costs and improve patient adherence, further enhancing the value proposition of BrainsWay's offerings.

Neurotechnology Market Analyst

BrainsWay's exploration of 'Deep TMS 360°™' technology in the field of neurostimulation represents a strategic move to solidify its position within a growing market. The global TMS market is projected to grow significantly, driven by the increasing prevalence of mental health conditions and the demand for noninvasive treatment options. The company's focus on conditions such as stroke and OCD aligns with high-impact areas where treatment innovation is critically needed.

From a market perspective, successful trials could position BrainsWay as a leader in next-generation TMS technologies, potentially catalyzing partnerships, licensing opportunities, or even acquisitions. Investors should monitor the progress of these trials closely, as positive results could lead to FDA clearance and commercialization, which would be a substantial value driver for BrainsWay's stock. Conversely, any setbacks in the trials could pose risks to the company's growth trajectory and investor confidence.

Healthcare Economist

The economic implications of BrainsWay's Rotational Field TMS technology extend beyond the company's financials into the broader healthcare landscape. The cost associated with mental health disorders and post-stroke rehabilitation is substantial and innovative treatments that offer improved efficacy and efficiency could lead to significant healthcare savings. If BrainsWay's technology reduces the duration of treatment while maintaining or enhancing efficacy, it could alleviate some of the financial burden on healthcare systems and patients.

In the long-term, widespread adoption of more effective TMS solutions could shift treatment paradigms, potentially reducing reliance on pharmacological interventions and their associated costs. However, the initial investment in new technologies and the training required to implement them could present short-term economic challenges. The balance between upfront costs and long-term savings will be a critical factor in the adoption rate of Rotational Field TMS by healthcare providers.

BURLINGTON, Mass. and JERUSALEM, Jan. 10, 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 it will be clinically evaluating an innovative stimulation technology in two new feasibility trials.

The studies both involve BrainsWay’s exclusive, patented “Rotational Field” TMS (or “Deep TMS 360°™”), which employs a method of stimulation that enables activation of a greater number of neurons in the brain. In all currently available forms of TMS, those neurons which are aligned parallel to the coil’s electric field are much more likely to be stimulated than other neurons. Thus, only a fraction of the neurons in the targeted brain region are actually impacted. With the new Rotational Field system now being evaluated, two orthogonal TMS coils are placed perpendicular to each other and are operated with a time lag in order to induce a circularly rotating electric field. This results in uniform stimulation of neurons oriented along a wide variety of directions in the targeted brain region – all within less than a millisecond.

The Company now aims to assess the potential clinical impact of this technology on patients in two newly launched feasibility studies. One study will test the safety and efficacy of this technology in the field of rehabilitation following stroke, a devastating neurological condition. Another study will test the technology in the field of obsessive-compulsive disorder (OCD) utilizing an accelerated protocol. BrainsWay’s existing Deep Transcranial Magnetic Stimulation (Deep TMS™) system is already FDA-cleared to treat OCD using the standard daily protocol via its H7 Coil, and this new study will test the ability to further improve outcomes using Rotational Field stimulation while also reducing the length of the standard treatment.

"We are proud to continue to be at the forefront of innovation in the field of noninvasive brain stimulation,” said Hadar Levy, Chief Executive Officer of BrainsWay. “We believe that our Rotational Field technology holds significant potential to change the current TMS paradigm. We look forward to testing its capabilities in these newly launched post-stroke rehabilitation and OCD feasibility studies.”

BrainsWay’s Rotational Field technology is not commercially available and has not yet been cleared for safety and/or efficacy by the FDA.

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 
844-386-7001 ext. 5
Ido.Marom@BrainsWay.com 

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

Media Contact:
Chris Boyer
844-386-7001 ext. 2
Chris.Boyer@BrainsWay.com

FAQ

What is BrainsWay Ltd.'s ticker symbol?

The ticker symbol for BrainsWay Ltd. is BWAY.

What is the innovative stimulation technology being evaluated by BrainsWay?

BrainsWay is evaluating its patented 'Rotational Field' TMS technology, which aims to stimulate a greater number of neurons in the brain.

What conditions are being targeted in the new feasibility trials?

The new feasibility trials will focus on testing the technology's potential impact on patients with stroke and obsessive-compulsive disorder (OCD).

Is the Rotational Field technology currently available for commercial use?

No, the Rotational Field technology is not yet commercially available and has not been cleared for safety and/or efficacy by the FDA.

What is the current FDA-cleared treatment for OCD by BrainsWay?

BrainsWay's existing Deep Transcranial Magnetic Stimulation (Deep TMS™) system is already FDA-cleared to treat OCD using the standard daily protocol via its H7 Coil.