BrainsWay Targets Expansion of its Total Addressable Market through a Strategic Investment in Neuromodulation Systems Developer, Neurolief Ltd.
BrainsWay (NASDAQ: BWAY) has made a strategic investment in Neurolief Ltd. through a $5 million convertible loan with an option to acquire the company. Neurolief is developing the first wearable, non-invasive, multi-channel brain neuromodulation platform for at-home use.
The agreement includes potential additional milestone-based funding: a $6 million convertible loan upon FDA approval of Neurolief's Proliv Rx system for Major Depressive Disorder (MDD), and a $5 million equity investment upon reaching specific revenue targets. BrainsWay has also secured a call option to acquire Neurolief's outstanding equity during defined exercise windows.
Neurolief's Proliv™Rx device is currently pending FDA Premarket Approval and, if granted, will become the first FDA-cleared medical device for MDD treatment that can be administered outside clinical settings. The company's Relivion®MG therapy is already approved in the U.S., Europe, and Japan for migraine treatment.
BrainsWay (NASDAQ: BWAY) ha effettuato un investimento strategico in Neurolief Ltd. tramite un prestito convertibile da 5 milioni di dollari con un'opzione di acquisizione della società. Neurolief sta sviluppando la prima piattaforma indossabile, non invasiva e multicanale per la neuromodulazione cerebrale destinata all'uso domiciliare.
L'accordo prevede finanziamenti aggiuntivi legati al raggiungimento di determinati obiettivi: un prestito convertibile da 6 milioni di dollari al momento dell'approvazione FDA del sistema Proliv Rx di Neurolief per il disturbo depressivo maggiore (MDD) e un investimento in capitale di 5 milioni di dollari al raggiungimento di specifici traguardi di fatturato. BrainsWay ha inoltre ottenuto un'opzione di acquisto per le azioni residue di Neurolief in finestre di esercizio definite.
Il dispositivo Proliv™Rx di Neurolief è attualmente in attesa dell'approvazione precommerciale FDA e, se approvato, diventerebbe il primo dispositivo medico autorizzato dalla FDA per il trattamento della MDD utilizzabile al di fuori delle strutture cliniche. La terapia Relivion®MG dell'azienda è già approvata negli Stati Uniti, in Europa e in Giappone per il trattamento dell'emicrania.
BrainsWay (NASDAQ: BWAY) ha realizado una inversión estratégica en Neurolief Ltd. mediante un préstamo convertible de 5 millones de dólares con una opción para adquirir la compañía. Neurolief está desarrollando la primera plataforma de neuromodulación cerebral multicanal, no invasiva y portátil para uso domiciliario.
El acuerdo incluye posibles fondos adicionales condicionados a hitos: un préstamo convertible de 6 millones de dólares tras la aprobación por la FDA del sistema Proliv Rx de Neurolief para el trastorno depresivo mayor (MDD), y una inversión en capital de 5 millones de dólares al alcanzar determinados objetivos de ingresos. BrainsWay también ha asegurado una opción de compra sobre el capital en circulación de Neurolief durante ventanas de ejercicio definidas.
El dispositivo Proliv™Rx de Neurolief está actualmente pendiente de la Aprobación Premarket de la FDA y, si se concede, será el primer dispositivo médico aprobado por la FDA para el tratamiento del MDD que puede administrarse fuera de entornos clínicos. La terapia Relivion®MG de la compañía ya cuenta con aprobación en EE. UU., Europa y Japón para el tratamiento de la migraña.
BrainsWay (NASDAQ: BWAY)는 500만 달러 전환 대출과 함께 회사를 인수할 수 있는 옵션을 포함한 전략적 투자를 Neurolief Ltd.에 진행했습니다. Neurolief는 가정용으로 사용할 수 있는 최초의 착용형 비침습 다중 채널 뇌 신경조절 플랫폼을 개발 중입니다.
이번 합의에는 추가적인 마일스톤 기반 자금 조달 가능성이 포함되어 있습니다: Neurolief의 Proliv Rx 시스템이 주요우울장애(MDD)에 대해 FDA 승인을 받을 경우 600만 달러 전환 대출, 특정 매출 목표 달성 시 500만 달러 지분 투자가 예정되어 있습니다. BrainsWay는 또한 정해진 행사 기간 동안 Neurolief의 미결 권리를 인수할 수 있는 콜 옵션을 확보했습니다.
Neurolief의 Proliv™Rx 장비는 현재 FDA 사전시장 승인(PMA)을 기다리고 있으며, 승인될 경우 임상 환경 밖에서 사용될 수 있는 MDD 치료용으로 FDA 승인을 받은 첫 번째 의료기기가 될 것입니다. 회사의 Relivion®MG 치료법은 이미 미국, 유럽 및 일본에서 편두통 치료에 대해 승인받았습니다.
BrainsWay (NASDAQ: BWAY) a réalisé un investissement stratégique dans Neurolief Ltd. via un prêt convertible de 5 millions de dollars assorti d'une option d'acquisition de la société. Neurolief développe la première plateforme portable, non invasive et multicanale de neuromodulation cérébrale destinée à un usage à domicile.
L'accord prévoit des financements supplémentaires éventuels conditionnés à des jalons : un prêt convertible de 6 millions de dollars en cas d'approbation par la FDA du système Proliv Rx de Neurolief pour le trouble dépressif majeur (MDD), et un investissement en capital de 5 millions de dollars au franchissement de certains objectifs de chiffre d'affaires. BrainsWay a également obtenu une option d'achat sur les actions en circulation de Neurolief pendant des fenêtres d'exercice définies.
Le dispositif Proliv™Rx de Neurolief est actuellement en attente de l'approbation pré-commerciale (PMA) de la FDA et, s'il est approuvé, deviendra le premier dispositif médical approuvé par la FDA pour le traitement du MDD pouvant être utilisé en dehors des structures cliniques. La thérapie Relivion®MG de la société est déjà approuvée aux États-Unis, en Europe et au Japon pour le traitement de la migraine.
BrainsWay (NASDAQ: BWAY) hat eine strategische Investition in Neurolief Ltd. über ein 5 Millionen US-Dollar wandelbares Darlehen mit einer Option zum Erwerb des Unternehmens getätigt. Neurolief entwickelt die erste tragbare, nichtinvasive Multi-Kanal-Plattform zur Gehirnneuromodulation für den Einsatz zu Hause.
Die Vereinbarung sieht potenzielle zusätzliche, leistungsabhängige Finanzierungen vor: ein 6 Millionen US-Dollar wandelbares Darlehen bei FDA-Zulassung des Proliv Rx-Systems von Neurolief für Major Depressive Disorder (MDD) sowie eine 5 Millionen US-Dollar Eigenkapitalinvestition bei Erreichen bestimmter Umsatzziele. BrainsWay hat zudem eine Kaufoption auf die ausstehenden Anteile von Neurolief innerhalb definierter Ausübungszeiträume gesichert.
Das Proliv™Rx-Gerät von Neurolief befindet sich derzeit im Verfahren zur FDA-Premarket-Zulassung und würde, falls genehmigt, das erste von der FDA zugelassene Medizinprodukt zur Behandlung von MDD sein, das außerhalb klinischer Einrichtungen angewendet werden kann. Die Relivion®MG-Therapie des Unternehmens ist bereits in den USA, Europa und Japan für die Behandlung von Migräne zugelassen.
- Strategic expansion into at-home mental health treatment market
- Structured deal with milestone-based funding reduces initial investment risk
- Call option provides flexibility for complete acquisition
- Potential first-mover advantage in out-of-clinic MDD treatment devices
- Geographic diversification with products approved in US, Europe, and Japan
- Initial $5 million investment with no immediate revenue generation
- FDA approval for Proliv Rx still pending with no guarantee of success
- Additional funding commitments of up to $11 million tied to milestones
Insights
BrainsWay's $5M investment in Neurolief strategically expands their market reach into at-home neuromodulation treatments with significant growth potential.
BrainsWay's
The investment targets a critical gap in the treatment landscape for Major Depressive Disorder (MDD). Neurolief's Proliv™Rx device, currently awaiting FDA Premarket Approval, would become the first FDA-cleared medical device for MDD treatment deliverable outside clinical settings. This positions BrainsWay to capture market share in two complementary treatment environments: clinic-based (through their existing Deep TMS platform) and at-home therapy (through Neurolief's technology).
The deal structure intelligently mitigates risk while maximizing potential upside. The initial
For investors, this represents BrainsWay's strategic pivot toward expanding its total addressable market in the growing neuromodulation sector. The acquisition call option, exercisable during specific windows at predetermined valuations, provides BrainsWay with significant future flexibility based on Neurolief's performance. The partnership also creates potential commercial synergies by leveraging BrainsWay's established distribution network and clinical relationships to accelerate Neurolief's market penetration.
This investment marks BrainsWay’s entrance into the market for mental health therapies that can be administered outside of a clinic, including at home
Neurolief’s breakthrough Proliv™Rx device is pending Premarket Approval from the U.S. FDA, and if granted, will become the first FDA-cleared medical device for MDD treatment that can be delivered outside of the clinic
BURLINGTON, Mass. and JERUSALEM, Aug. 21, 2025 (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 it has closed an initial strategic investment by means of a
“We are very excited with this strategic investment in Neurolief. Upon an FDA approval, we believe this technology will significantly expand our addressable market, enabling care for patients who cannot easily access clinics and empowering medical professionals to extend treatment beyond traditional settings. This aligns with our strategic goal of accelerating access to and awareness of innovative mental health treatments, especially offerings that we believe are complementary to mental health professionals using our Deep TMS therapy,” said Hadar Levy, BrainsWay’s Chief Executive Officer. “The BrainsWay team has rapidly expanded sales of the Deep TMS™ system, supported by scaling of our commercial platform and customer network. We are excited by the opportunity to leverage our platform and explore potential synergies between our two companies, as Neurolief brings its at-home neuromodulation systems to the market through mental health professionals.”
Neurolief is a pioneering neuromodulation company dedicated to developing innovative solutions for mental health and neurological disorders. Neurolief's Relivion®MG therapy is currently approved in the U.S., Europe and Japan for the treatment of migraine, and it is awaiting Premarket Approval from the U.S. FDA for its ProlivTMRx therapy addressing Major Depressive Disorder (MDD) in treatment resistant patients. If approved, Neurolief will be the first medical device company to offer an FDA-cleared MDD treatment that can be delivered outside of the clinic.
MDD is a leading cause of disability globally, with millions of people affected. The situation is especially dire for those patients who fail to respond to traditional treatments, facing prolonged suffering, higher healthcare costs, and a heightened risk of comorbid conditions such as substance abuse and suicide. Despite the global impact of MDD, there is a critical gap in accessible, effective therapies, particularly for these patients. Proliv™Rx is designed to bridge this gap by offering a revolutionary, non-invasive brain neuromodulation therapy that can be administered at a mental health clinic or a patient’s home.
“This strategic investment by BrainsWay is a strong validation of our science, our team, and our vision,” stated Scott Drees, Neurolief's Chief Executive Officer. “This partnership enhances our ability to reach the patients who need our therapy most. BrainsWay’s market presence, deep expertise, and established commercial platform can complement our innovation and momentum. Together, we aim to reshape the treatment landscape for depression and expand access to evidence-based, effective care.”
Beyond the initial
Through this multi-phased transaction, BrainsWay aims to expand its long-term total addressable market.
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 operations in the United States and 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.
About Neurolief
Neurolief is a pioneering neuromodulation company committed to developing breakthrough therapies for mental health and neurological disorders. The company has developed the world’s first wearable, non-invasive, multi-channel brain neuromodulation system, that is designed for use at home, engineered to simultaneously stimulate key neural pathways in the head in order to modulate brain regions involved in regulation of mood and pain. Neurolief's technology is currently FDA-cleared and CE-marked for the treatment of migraine, and the company is actively seeking regulatory approvals for Proliv™Rx, its flagship product for the treatment of Major Depressive Disorder. If granted, Neurolief will be the first medical device company to offer an FDA-approved MDD treatment that can be delivered outside of the clinic. Learn more at: www.neurolief.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,” “targets,” “believes,” “hopes,” “potential” or similar words, and also includes any financial guidance and projections contained herein. 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 – especially preliminary data which remains subject to peer-review – 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: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of our investments in management services organizations and/or other clinic-related entities to produce profitable returns; 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
FAQ
What is the value of BrainsWay's (BWAY) initial investment in Neurolief?
What are the milestone payments in BrainsWay's investment in Neurolief?
What products does Neurolief currently have approved?
How will this investment affect BrainsWay's market position?
What is unique about Neurolief's Proliv™Rx device?
