Nexalin Technology, Inc. secured clearance from the Israeli Ministry of Health for its Gen‑2 SYNC 15‑mA neurostimulation device, enabling the company to market and sell the product in Israel.
The Gen‑2 SYNC platform uses Deep Intracranial Frequency Stimulation (DIFS™) technology and is designed to treat mental health disorders without medication. The approval follows prior approvals in China, Brazil, and Oman.
The clearance removes a key barrier to commercial sales in Israel and supports Nexalin’s strategy to expand its presence in the Middle East and North Africa. The company’s CEO, Mark White, highlighted Israel’s rigorous regulatory standards as a validation of the technology.
Nexalin’s financial results for 2024 show a net loss of $7.6 million, up from a $4.6 million loss in 2023, and total revenues of $168,721, compared with $110,748 in 2023. Operating expenses increased due to higher professional fees, salaries, and stock‑based compensation.
The company maintains a strong liquidity position, with a current ratio of 10.44 and more cash than debt, providing flexibility to pursue further product development, including the Gen‑3 Halo headset and expanded indications for Alzheimer’s disease.
Nexalin’s regulatory strategy includes securing a local representative in Israel, a requirement for market entry, and the company plans to leverage the Israeli approval to negotiate distribution agreements across the region.
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