Nexalin Technology Provides 2022 Year-End Business Update

About this update from Nexalin Technology, Inc.

[{"type":"text","content":"HOUSTON, March 27, 2023 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW) today provided a business update for the year ended December 31, 2022. Mark White, CEO of Nexalin Technology stated, “Nexalin has made significant progress towards commencing clinical trials of our Gen-2 and Gen-3 neurostimulation devices in the United States. Nexalin’s enhanced neurostimulation devices combine innovation, frequencies and algorithms to provide an unprecedented solution for treating mental health disorders without the need for medication. Although our Gen-1 device was previously cleared by the U.S. Food and Drug Administration (FDA) to treat patients with anxiety, depression, and insomnia, we believe that the new devices will allow deeper penetration into the brain and provide enhanced patient response without adverse side effects. Given changes in FDA medical device requirements, the Company decided to not continue with the Gen-1 device, given the success of the new devices, based on both studies and approvals in China. Moreover, we are highly encouraged by the preliminary data provided by the University of California San Diego that supports the safety of utilizing our next generation devices. As a result, we look forward to presenting our new Gen-2 and Gen-3 devices to the FDA in the coming months for the treatment of anxiety and insomnia. We are also on track to submit our PMA with the FDA for the treatment of Major Depressive Disorder (MDD) in Q3 2023. In addition, we seek to expand our neurostimulation devices into new indications, such as substance use disorder (addiction), Alzheimer’s, traumatic brain injury (TBI), PTSD and chronic pain. Overall, we remain committed to our mission of bringing our new, effective and drug-free therapy to patients with mental health issues in the United States and around the world.” “Shortly after receiving the approval of our Generation 2 (Gen-2) medical device by China’s National Medical Products Administration (NMPA) for insomnia and depression, our distributor, Wider Come Limited, commenced sales of our Gen-2 devices in China. Although we are pleased with our revenue growth in 2022, our sales in China were greatly affected by the pandemic. Despite this, our distributor continues to focus on selling the instrument and disposables to key opinion leaders at ...

More updates from Nexalin Technology, Inc.