HOUSTON - Nexalin Technology, Inc. (NASDAQ:NXL; NXLIW), a company specializing in non-invasive neurostimulation medical devices, has received regulatory approval from the Sultanate of Oman's Ministry of Health for its second generation 15 milliamp (mA) neurostimulation device. The announcement marks the company's first regulatory approval outside of China, positioning Oman as a strategic entry point into the Middle East market.
CEO Mark White expressed optimism about the company's future, anticipating further approvals in additional markets globally. He said, "We are pleased to announce the approval to sell our Gen-2 neurostimulation device in Oman, which represents our first regulatory approval outside of China. Not only is Oman an important gateway to the Middle East, but we intend to seek, and expect to be granted, additional approvals in other markets around the world. We look forward to finalizing our first commercial distribution agreement in Oman within the coming weeks and commencing commercial sales soon thereafter. We are laser-focused on opening new international markets and securing commercial distribution partners to rapidly and cost-effectively scale the business."
The Gen-2 neurostimulation device, designed to treat mental health issues such as insomnia and depression without adverse side effects, aligns with Nexalin's mission to address the global mental health epidemic. The device, which uses bioelectronic technology to reach deep structures in the mid-brain, was previously approved in China by the National Medical Products Administration (NMPA).
Nexalin's approach to mental health treatment involves non-invasive, drug-free solutions that are undetectable to the human body. The company believes its technology's deep-penetrating waveform will enhance patient response rates.
The information in this article is based on a press release statement from Nexalin Technology, Inc.
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