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CORAL SPRINGS, Fla./NETANYA, Israel - Neurolief, a non-invasive neuromodulation therapy developer, has received a strategic investment from BrainsWay Ltd. (NASDAQ & TASE:BWAY) as it awaits FDA approval for its Proliv™Rx device for treating Major Depressive Disorder (MDD), according to a press release issued Thursday.
The investment aims to support Neurolief’s commercial preparations for the Proliv™Rx system, which is designed to provide at-home brain stimulation therapy for depression patients. The device would represent a new category in neuromodulation by allowing treatment outside clinical settings. According to InvestingPro data, BrainsWay maintains a strong financial position with a current ratio of 3.51, indicating robust capability to fund strategic investments.
"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.
The Proliv™Rx system is being positioned as an alternative for patients who don’t respond adequately to antidepressant medications. If approved, it would be the first FDA-approved MDD treatment device that can be used outside clinical settings.
BrainsWay, which markets its Deep Transcranial Magnetic Stimulation technology in over 1,500 clinics globally, brings commercial expertise that could help Neurolief scale its operations following potential regulatory approval. With a market capitalization of $287.36 million and an "GREAT" financial health score according to InvestingPro, BrainsWay appears well-positioned to support this strategic initiative. Discover 14+ additional exclusive insights about BrainsWay and access comprehensive Pro Research Reports covering 1,400+ top stocks through an InvestingPro subscription.
Dr. Mark S. George, Professor of Psychiatry and Neurology at the Medical University of South Carolina, noted in the announcement that many depressed patients cannot access office-based brain stimulation therapies due to childcare responsibilities, work commitments, or distance from clinics.
Neurolief’s technology has already received FDA clearance and CE marking for migraine treatment. The company describes its system as the first wearable, non-invasive, multi-channel brain neuromodulation system designed for home use.
The financial terms of the investment were not disclosed in the company’s statement.
In other recent news, BrainsWay Ltd. reported record net revenue of $12.6 million for the second quarter of 2025, along with net earnings of $0.05 per share. The company achieved a 35% increase in shipments of its Deep Transcranial Magnetic Stimulation (Deep TMS) systems, totaling 88 units for the quarter. H.C. Wainwright responded by raising its price target for BrainsWay to $17 from $16, maintaining a Buy rating. Additionally, BrainsWay announced promising preliminary results from a multicenter trial of its accelerated Deep TMS protocol for major depressive disorder. The trial involved 104 patients and suggested that the accelerated protocol requires fewer clinic visits while maintaining efficacy. In strategic moves, BrainsWay invested $5 million in Neurolief Ltd., with an option to acquire the company, and $2.3 million in Axis Management Company, Inc., with potential additional funding based on milestones. These investments aim to expand BrainsWay’s reach in mental health care services.
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