BrainsWay Ltd. received Premarket Approval from the U.S. Food and Drug Administration for Neurolief’s Proliv™Rx system on January 12, 2026. The Class III device is the first at‑home neuromodulation therapy that carries FDA labeling for treatment‑refractory major depressive disorder (MDD) in adults who have not responded to at least one antidepressant. The approval marks a milestone for both companies, as it validates the safety and effectiveness of a wearable, non‑invasive platform that can be used outside of a clinical setting.
The approval follows BrainsWay’s strategic investment in Neurolief, which includes an option to acquire the company. BrainsWay CEO Hadar Levy said the decision “validates the partnership and expands our value proposition by adding an at‑home modality that can reach patients who cannot easily access clinic‑based Deep TMS.” The move positions BrainsWay to capture a new segment of the mental‑health market and potentially increase its total addressable market by offering a convenient, home‑based alternative to clinic‑based neuromodulation.
BrainsWay’s recent financial results underscore the commercial potential of the new device. In the fourth quarter of 2024, the company generated $11.4 million in revenue, up 27% year‑over‑year, and reported a gross margin of 75%. Full‑year 2024 revenue reached $41.0 million, a 29% increase from 2023, while operating income rose to $1.4 million from a $5.0 million loss the previous year. BrainsWay has guided 2025 revenue to $49 million–$51 million, reflecting confidence that the expanded product line will drive growth. The at‑home Proliv™Rx platform is expected to generate recurring subscription revenue, aligning with BrainsWay’s strategy to shift toward scalable, subscription‑style models.
The FDA approval opens a sizable market opportunity. Treatment‑refractory MDD affects an estimated 4–5 % of adults with depression, and current options—such as electroconvulsive therapy, ketamine, and esketamine—require clinical visits or have limited availability. Proliv™Rx’s at‑home delivery could reach patients who live in rural areas or have mobility constraints, thereby expanding BrainsWay’s reach beyond the limited clinic capacity of its Deep TMS system. By offering a first‑in‑class home therapy, BrainsWay can differentiate itself from competitors that rely solely on clinic‑based neuromodulation.
While the announcement does not disclose a commercialization timeline or specific pricing, the device’s PMA status signals that it has met the FDA’s most stringent safety and effectiveness criteria. Neurolief’s platform already holds FDA, CE, and PMDA approvals for migraine treatment, suggesting a proven regulatory pathway. BrainsWay’s option to acquire Neurolief could further consolidate its neuromodulation portfolio, but no valuation or deal terms have been released. The company’s focus on subscription revenue and scalable delivery positions it to capitalize on the growing demand for convenient, at‑home mental‑health solutions.
Overall, the FDA approval of Proliv™Rx represents a significant expansion of BrainsWay’s therapeutic offerings and a strategic step toward a broader, more accessible mental‑health portfolio. The combination of a proven at‑home platform, a growing treatment‑refractory MDD market, and BrainsWay’s subscription‑focused business model suggests that the approval could materially enhance the company’s revenue trajectory and competitive positioning.
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