Neurolief Prepares for Launch of its Proliv™Rx System for Major Depressive Disorder with Strategic Investment from BrainsWay
BrainsWay (NASDAQ: BWAY) has made a strategic investment in Neurolief, a brain stimulation company developing non-invasive neuromodulation therapies. The investment comes as Neurolief awaits FDA approval for its Proliv™Rx system, designed to treat Major Depressive Disorder (MDD).
The Proliv™Rx system represents a breakthrough in depression treatment, offering at-home brain neuromodulation therapy for patients who haven't responded adequately to traditional antidepressants. BrainsWay's commercial expertise and global presence, with Deep TMS systems in over 1,500 clinics worldwide, positions Neurolief for significant market penetration post-FDA approval.
The partnership aims to address a critical gap in mental health care, particularly for patients who have limited access to clinic-based treatments due to factors such as childcare, employment, or geographical constraints.
BrainsWay (NASDAQ: BWAY) ha effettuato un investimento strategico in Neurolief, un'azienda che sviluppa terapie di neuromodulazione non invasive. L'investimento arriva mentre Neurolief attende la approvazione FDA per il sistema Proliv™Rx, pensato per il trattamento del Disturbo Depressivo Maggiore (MDD).
Il sistema Proliv™Rx rappresenta un progresso nel trattamento della depressione, offrendo una terapia di neuromodulazione cerebrale a domicilio per pazienti che non hanno risposto in modo soddisfacente agli antidepressivi tradizionali. L'esperienza commerciale di BrainsWay e la sua presenza globale, con sistemi Deep TMS in oltre 1.500 cliniche nel mondo, pongono Neurolief in una posizione favorevole per una significativa penetrazione del mercato una volta ottenuta l'approvazione FDA.
La partnership punta a colmare una lacuna critica nella cura della salute mentale, in particolare per quei pazienti che incontrano difficoltà ad accedere a trattamenti in clinica a causa di impegni familiari, lavorativi o limitazioni geografiche.
BrainsWay (NASDAQ: BWAY) ha realizado una inversión estratégica en Neurolief, una compañía que desarrolla terapias de neuromodulación no invasiva. La inversión llega mientras Neurolief espera la aprobación de la FDA para su sistema Proliv™Rx, diseñado para tratar el Trastorno Depresivo Mayor (MDD).
El sistema Proliv™Rx supone un avance en el tratamiento de la depresión, ofreciendo una terapia de neuromodulación cerebral en el hogar para pacientes que no han respondido adecuadamente a los antidepresivos tradicionales. La experiencia comercial de BrainsWay y su presencia global, con sistemas Deep TMS en más de 1.500 clínicas en todo el mundo, posicionan a Neurolief para una importante penetración en el mercado tras la aprobación de la FDA.
La alianza pretende cubrir una brecha crítica en la atención de la salud mental, especialmente para pacientes con acceso limitado a tratamientos en clínicas debido a factores como cuidado de hijos, trabajo o barreras geográficas.
BrainsWay (NASDAQ: BWAY)가 비침습적 신경조절 치료법을 개발하는 뇌 자극 기업 Neurolief에 전략적 투자를 단행했습니다. 이 투자는 Neurolief가 주요우울장애(MDD) 치료를 위한 Proliv™Rx 시스템의 FDA 승인을 기다리는 가운데 이뤄졌습니다.
Proliv™Rx 시스템은 우울증 치료에 있어 획기적인 진전으로, 기존 항우울제에 충분히 반응하지 않은 환자들을 위한 자가(가정)용 뇌 신경조절 치료를 제공합니다. 전 세계 1,500개 이상 클리닉에 Deep TMS 시스템을 보유한 BrainsWay의 상업적 역량과 글로벌 네트워크는 FDA 승인 후 Neurolief의 시장 진출에 유리한 조건을 제공합니다.
이번 파트너십은 보육, 근무 등 이유나 지리적 제약으로 클리닉 기반 치료에 접근하기 어려운 환자들을 위해 정신건강 관리의 중요한 공백을 해소하는 것을 목표로 합니다.
BrainsWay (NASDAQ: BWAY) a réalisé un investissement stratégique dans Neurolief, une société développant des thérapies de neuromodulation non invasives. Cet investissement intervient alors que Neurolief attend la validation de la FDA pour son système Proliv™Rx, destiné au traitement du trouble dépressif majeur (MDD).
Le système Proliv™Rx constitue une avancée dans le traitement de la dépression en proposant une thérapie de neuromodulation cérébrale à domicile pour les patients n'ayant pas suffisamment répondu aux antidépresseurs classiques. L'expertise commerciale de BrainsWay et sa présence mondiale, avec des systèmes Deep TMS dans plus de 1 500 cliniques à travers le monde, placent Neurolief en bonne position pour une forte pénétration du marché après l'approbation de la FDA.
Le partenariat vise à combler une lacune cruciale dans les soins de santé mentale, notamment pour les patients ayant un accès limité aux traitements en clinique en raison de la garde d'enfants, d'obligations professionnelles ou de contraintes géographiques.
BrainsWay (NASDAQ: BWAY) hat eine strategische Beteiligung an Neurolief erworben, einem Unternehmen, das nichtinvasive Neuromodulations‑Therapien entwickelt. Die Investition erfolgt, während Neurolief auf die FDA‑Zulassung für sein Proliv™Rx‑System wartet, das zur Behandlung der Major Depressive Disorder (MDD) konzipiert ist.
Das Proliv™Rx‑System stellt einen Durchbruch in der Depressionsbehandlung dar und bietet eine häusliche Hirn‑Neuromodulations‑Therapie für Patienten, die auf herkömmliche Antidepressiva nicht ausreichend angesprochen haben. BrainsWays kommerzielle Expertise und globale Präsenz mit Deep‑TMS‑Systemen in über 1.500 Kliniken weltweit verschaffen Neurolief gute Voraussetzungen für eine starke Marktposition nach FDA‑Zulassung.
Die Partnerschaft zielt darauf ab, eine wichtige Lücke in der psychischen Gesundheitsversorgung zu schließen, insbesondere für Patienten, die aus Gründen wie Kinderbetreuung, Beruf oder geografischer Entfernung nur eingeschränkt Zugang zu klinikbasierten Behandlungen haben.
- Strategic partnership with BrainsWay provides access to established commercial infrastructure across 1,500 clinics globally
- Innovative at-home treatment solution addresses significant market gap in depression therapy
- Pending FDA approval for Proliv™Rx system could open new revenue streams
- Technology offers treatment alternative for patients unresponsive to traditional antidepressants
- FDA approval still pending and not guaranteed
- Will face competition from established depression treatments including traditional TMS
- Market adoption of new treatment modality may take time
Insights
BrainsWay's strategic investment in Neurolief positions it in the emerging at-home neuromodulation market for depression treatment, enhancing its commercial portfolio.
BrainsWay's strategic investment in Neurolief represents a calculated move into the at-home neuromodulation space, complementing its existing clinical-based Deep TMS technology. While the press release doesn't disclose the investment amount, this partnership gives BrainsWay early positioning in what could become a significant market expansion opportunity.
Neurolief's Proliv™Rx system represents a potentially disruptive innovation in depression treatment as it's designed for at-home use, addressing a critical market gap between traditional antidepressants and clinic-based neuromodulation therapies like BrainsWay's Deep TMS. The at-home application could substantially expand the addressable market for neuromodulation therapies beyond the current 1,500 clinics where BrainsWay has deployments.
This strategic alignment allows BrainsWay to hedge against potential competition from the at-home neuromodulation segment while leveraging its existing commercial infrastructure and clinical relationships to help scale Neurolief's technology post-FDA approval. The partnership creates a more comprehensive product portfolio that spans both clinical and home-based neuromodulation treatments.
The endorsements from prominent experts in neuromodulation (Dr. George from MUSC and Dr. Carpenter from Brown University) lend clinical credibility to Neurolief's approach. However, investors should note that FDA approval remains pending, creating regulatory uncertainty despite the optimistic positioning in the release. The commercial timeline and revenue impact remain undefined pending this critical regulatory milestone.
"We are on the brink of introducing an entirely new category in neuromodulation - bringing at-home treatment for major depressive disorder," said Scott Drees, Chief Executive Officer at Neurolief. "With BrainsWay's commercial expertise and the global reach of its proprietary Deep TMS system deployed in over 1,500 clinics globally, we are well-positioned to scale following our pending FDA approval and deliver a much-needed therapeutic solution for the millions affected by this debilitating condition."
Addressing the Urgent Need for Innovation in Depression Treatment
Major Depressive Disorder remains one of the most prevalent and burdensome mental health conditions worldwide. A significant subset of patients fails to respond adequately to traditional treatments such as antidepressant medications, resulting in prolonged illness, increased healthcare costs, and heightened risks of comorbidities including substance use disorders and suicide. The lack of adequately accessible therapies for these patients highlights a critical gap in mental health care, emphasizing the urgent need for innovative and effective treatment strategies. 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. By delivering effective brain stimulation through a wearable at-home therapy, Neurolief offers a fundamentally different approach - one that has the potential to radically shift how major depressive disorder is treated and address the unmet needs of patients who did not achieve improvement with traditional treatments.
"So many depressed patients do not respond to medications and cannot access the office-based new brain stimulation therapies like TMS as they have child-care, jobs, or live too far from clinics," said Dr. Mark S. George, Professor of Psychiatry and Neurology at the Medical University of
"The Proliv™Rx therapy represents an ideal solution for patients who have not experienced sufficient relief from antidepressants," said Dr. Linda Carpenter, Professor of Psychiatry at Brown University and Neuromodulation Program Director at Butler Hospital. "It's accessibility and at-home application offer a practical and effective alternative that could help prevent the progression to more severe and chronic illness. I'm excited about its potential to reshape how we treat depression."
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 home use, 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
About BrainsWay
BrainsWay Ltd. is a global leader in advanced, non-invasive neurostimulation therapies for mental health conditions. The company's proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform is FDA-cleared for three indications: major depressive disorder (including anxious depression), obsessive-compulsive disorder (OCD), and smoking addiction - all supported by pivotal clinical studies demonstrating efficacy. BrainsWay is committed to transforming lives and advancing neuroscience through clinically proven technologies. Learn more at: www.brainsway.com
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SOURCE Neurolief
FAQ
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