Welcome to our dedicated page for Nexalin Technology news (Ticker: NXL), a resource for investors and traders seeking the latest updates and insights on Nexalin Technology stock.
Nexalin Technology, Inc. (NASDAQ: NXL) is a pioneering company in the field of neurostimulation, offering non-invasive and drug-free therapies for individuals suffering from anxiety, depression, and insomnia. The company has developed a patented device that uses transcranial electrical stimulation (tES), producing a unique waveform designed to stimulate brain activity and normalize neurochemical levels. This treatment aims to provide lasting relief from mental health conditions without the adverse side effects typically associated with drugs or psychotherapy.
One of the core products from Nexalin is the Gen-1 device, classified as a Class II medical device by the U.S. Food and Drug Administration (FDA). This cranial electrotherapy stimulation (CES) device emits a waveform at 4 milliamps during treatments and has been shown to increase beta-endorphins significantly during clinical trials.
Nexalin is also advancing the development of its Gen-2 and Gen-3 HALO™ Clarity devices, which aim to offer deeper brain penetration and enhanced patient response without side effects. The company's Gen-2 device was recently approved by the National Medical Products Administration (NMPA) in China for treating insomnia and depression and is distributed in the Asia Pacific region through a joint venture with Wider Come Limited.
Recent achievements include a collaborative study involving the U.S. Department of Veterans Affairs and UC San Diego, which demonstrated a significant decrease in post-concussion syndrome (PCS) and PTSD symptoms in veteran patients using the Gen-2 device. Moreover, the company continues to gather clinical data supporting its neurostimulation technology and is making progress in advancing its new Gen-3 HALO™ Clarity Virtual Clinic model.
Nexalin is committed to addressing the global mental health crisis through innovative solutions. The company's non-invasive devices are developed to be undetectable to the human body, ensuring a comfortable treatment experience. With ongoing research and development, Nexalin aims to extend the reach of its therapies to benefit more people worldwide.
Nexalin Technology announced that the FDA has provided feedback and reached consensus on the design for clinical studies of its Gen-3 HALO Clarity™ headset. These studies, focusing on anxiety and insomnia, are set to commence in Q3 2024. Each study will involve 75 patients receiving active treatment and 75 receiving sham treatment. The HALO device uses Deep Intracranial Frequency Stimulation (DIFS™) to potentially offer an effective alternative to pharmacological treatments. Following the studies, Nexalin plans to submit a De Novo request to the FDA, seeking a new marketing pathway for the device.
The production of over 500 units of the HALO headset has started to support these studies. Nexalin aims to manage the patient-physician relationship through a virtual clinic model, allowing at-home use with remote monitoring by a physician. CEO Mark White sees this as a significant step towards revolutionizing mental health treatment standards.
Nexalin Technology announced that its new division, Nexalin America, has joined the National Traumatic Brain Injury (TBI) Registry Coalition. This Coalition comprises private sector and non-profit organizations dedicated to advancing research, raising awareness, and supporting clinical trials for TBI, affecting millions annually. Members include the NFL Players Association, Spaulding Rehabilitation at Mass General, United States Brain Injury Alliance, Abbott, and American Academy of Neurology. Nexalin America will leverage its neurostimulation technology expertise to contribute to developing a national TBI registry. CEO Mark White highlighted this partnership as a significant step towards combating brain injuries through advanced technology and collaborative research.
Nexalin Technology, Inc. is hosting an exclusive live investor webinar on May 23, 2024, featuring CEO Mark White discussing the company's clinical data on its deep brain stimulation device and new clinic model. Investors can register for the event and submit questions online.
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