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BURLINGTON, Mass. - BrainsWay Ltd. (NASDAQ & TASE:BWAY) has closed a $5 million convertible loan investment in Neurolief Ltd., a developer of wearable neuromodulation technology for mental health disorders, according to a press release statement issued Thursday.
The strategic investment marks BrainsWay’s entry into the market for mental health therapies that can be administered outside clinical settings, including at-home treatment options. The agreement includes an option to acquire Neurolief and potential additional milestone-based funding.
Neurolief’s ProlivRx device for treatment-resistant major depressive disorder (MDD) is currently pending Premarket Approval from the U.S. FDA. If approved, it would become the first FDA-cleared medical device for MDD treatment deliverable outside clinical settings.
"Upon an FDA approval, we believe this technology will significantly expand our addressable market, enabling care for patients who cannot easily access clinics," said Hadar Levy, BrainsWay’s Chief Executive Officer. The company’s market expansion strategy comes amid impressive growth, with revenue increasing 26.5% over the last twelve months and the stock trading near its 52-week high of $15.00. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report available on InvestingPro.
The investment agreement provides for potential additional funding, including a second tranche of up to $6 million upon FDA approval of Neurolief’s ProlivRx system and a third tranche of up to $5 million upon Neurolief achieving certain revenue targets.
BrainsWay, a provider of Deep Transcranial Magnetic Stimulation technology, currently holds FDA clearances for treating major depressive disorder, obsessive-compulsive disorder, and smoking addiction. The company maintains a robust gross profit margin of 74.52%, reflecting strong operational efficiency in its medical device business. While the stock has delivered an impressive year-to-date return of 56.63%, InvestingPro analysis suggests the stock may be trading above its Fair Value.
Neurolief’s RelivionMG therapy is already approved in the U.S., Europe, and Japan for migraine treatment. The company’s ProlivRx system is designed as a non-invasive brain neuromodulation therapy that can be administered at mental health clinics or in patients’ homes.
Scott Drees, Neurolief’s Chief Executive Officer, called the investment "a strong validation of our science, our team, and our vision."
In other recent news, BrainsWay reported record quarterly net revenue of $12.6 million for the second quarter of 2025, alongside net earnings of $0.05 per share. The company shipped 88 Deep Transcranial Magnetic Stimulation (Deep TMS) systems during the quarter, marking a 35% increase from the previous year and bringing its total installed base to 1,522 systems. BrainsWay has also announced preliminary results from a multicenter trial indicating that its accelerated Deep TMS protocol for major depressive disorder shows comparable efficacy to standard treatment while requiring fewer clinic visits. This trial involved 104 adult patients across eight sites. Additionally, BrainsWay has entered into a strategic equity financing agreement with Axis Management Company, investing $2.3 million initially, with a potential additional $1 million based on milestones. Furthermore, the company invested $5 million into Stella MSO, gaining a minority stake as part of its initiative to support innovative mental health treatments. Analyst firm H.C. Wainwright has raised its price target on BrainsWay to $17 from $16 while maintaining a Buy rating. The firm also reiterated a Buy rating following the company’s announcement of promising trial results for its accelerated depression therapy.
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