BrainsWay's Expansion Plans and Strategic Investment
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, it will set a precedent as the first FDA-cleared medical device for treating Major Depressive Disorder (MDD) that can be used outside of a clinical setting.
BURLINGTON, Mass. and JERUSALEM — BrainsWay Ltd. (NASDAQ: BWAY) is taking bold steps in the neuromodulation industry with a significant investment aimed at enhancing mental health treatment options. Recently, BrainsWay announced the closing of a $5 million convertible loan to Neurolief Ltd., a pioneer in developing home-use brain neuromodulation systems targeting conditions like MDD and migraine. This agreement also opens the door to additional funding contingent upon achieving specified milestones.
“We are thrilled about this strategic investment in Neurolief,” said Hadar Levy, CEO of BrainsWay. “Once FDA approval is secured, we believe this technology will vastly broaden our potential market, allowing us to deliver care to patients who find it challenging to visit clinics, and empowering healthcare providers to broaden their treatment reach. This initiative aligns perfectly with our goal of enhancing awareness and accessibility of groundbreaking mental health interventions that can work alongside our Deep TMS therapy,” he further explained.
Neurolief is at the forefront of innovation in neuromodulation, dedicated to creating solutions for mental health and neurological disorders. Its flagship therapy, RelivionMG, is already approved in markets including the U.S., Europe, and Japan for migraine treatment. Neurolief is anticipating the approval of its Proliv™Rx therapy which specifically addresses treatment-resistant cases of MDD. If approved, they will stand as the first company to offer an FDA-certified MDD treatment that patients can use at home.
MDD is a prominent cause of disability globally, affecting countless lives. Those who do not respond to traditional treatments often endure prolonged distress, face increased healthcare expenses, and have a greater risk of severe complications, including substance abuse and suicidal tendencies. Even with the massive impact of MDD, there remains a significant lack of accessible, effective treatments. The introduction of Proliv™Rx aims to fill this critical gap by providing a revolutionary non-invasive brain neuromodulation therapy suitable for use both in clinical settings and at home.
“This strategic investment by BrainsWay validates our innovative vision and commitment,” affirmed Scott Drees, CEO of Neurolief. “Our collaboration enhances our capacity to deliver essential therapy to those in need. BrainsWay’s established market presence and expertise can significantly complement our innovations and drive forward our momentum. Together, we endeavor to transform the treatment landscape for depression, ensuring that more patients can access evidence-based, effective care,” he added.
In addition to the initial funding, the agreement details further milestone-based investments, such as an additional $6 million convertible loan that will be accessible upon receipt of FDA approval for Neurolief’s Proliv™Rx system. Furthermore, there is an option for an equity investment of up to $5 million contingent upon Neurolief achieving defined revenue targets. BrainsWay has also secured a “call option” to acquire Neurolief’s outstanding equity during specific exercise periods, priced based on certain pre-established metrics.
This phased investment strategy is aimed at broadening BrainsWay's long-term total addressable market, reflecting their commitment to innovative mental health solutions.
About BrainsWay
BrainsWay stands as a global leader in non-invasive neurostimulation treatments intended for mental health disorders. With its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform, the company strives to enhance health outcomes and make positive transformations in lives affected by mental illness. BrainsWay is recognized as the first and sole TMS company to have three FDA-cleared indications, supported by pivotal clinical studies that validate their efficacy. Current applications include treatment for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The company continues its dedication to advancing superior scientific approaches while capitalizing on an extensive body of clinical evidence regarding Deep TMS technology. Current trials for Deep TMS encompass various psychiatric, neurological, and addiction disorders. Established in 2003, with operations in the U.S. and Israel, BrainsWay is devoted to promoting global awareness and accessibility for its Deep TMS technology.
About Neurolief
Neurolief is a trailblazing company in neuromodulation, focused on delivering innovative treatments for mental health and neurological disorders. They have pioneered the world's first wearable, non-invasive, multi-channel brain neuromodulation system, which is specifically designed for home use. This technology stimulates key brain pathways concurrently to modulate regions responsible for mood regulation and pain management. Currently, Neurolief’s migraine treatment is FDA-cleared and CE-marked, while they await approval for Proliv™Rx, which aims to treat MDD. If granted, this innovative device will mark Neurolief as a leader in home-based FDA-approved MDD therapies.
Frequently Asked Questions
What is the significance of BrainsWay's investment in Neurolief?
BrainsWay's investment opens new avenues for accessible mental health treatments through innovative home-use therapies, expanding their market reach.
What is the Proliv™Rx device?
The Proliv™Rx device is Neurolief's groundbreaking neuromodulation technology targeting treatment-resistant MDD, awaiting FDA approval for home use.
How does the partnership benefit both companies?
This partnership leverages BrainsWay's market expertise and resources with Neurolief's innovative technology, enhancing treatment access for patients.
What conditions do BrainsWay's treatments address?
BrainsWay's therapies target major depressive disorder, obsessive-compulsive disorder, and smoking addiction, utilizing their Deep TMS technology.
What is Neurolief's approach to treatment?
Neurolief focuses on developing non-invasive neuromodulation solutions that stimulate brain pathways for enhancing mental health and alleviating pain.
