Nexalin Technology CEO Provides Letter to Shareholders

Rhea-AI Summary

Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) provided a business update emphasizing its advancements in neurostimulation devices aimed at combating mental health disorders. The company is enhancing its Gen-1 device to a more powerful Gen-2 model with a waveform increase from 4 milliamps to 15 milliamps, expected to improve treatment efficacy. Plans for FDA submissions and clinical trials are outlined, including a strategy for addressing Major Depressive Disorder. Additionally, Nexalin reports progress with its devices in China and a recent white paper supporting its technology's effectiveness for anxiety treatment.

Positive

• Advancement of Gen-1 device to a more powerful Gen-2 with a waveform increase from 4 milliamps to 15 milliamps.
• Plans for FDA submissions of Gen-2 and Gen-3 devices in Q1 2023.
• Successful progress with commercial rollout in China and additional clinical trials planned.
• Publication of supportive white paper validating the effectiveness of Gen-2 for anxiety treatment.
• Achieved historic milestone by listing on Nasdaq and raising $9.6 million, enhancing investor base.

Negative

• Market volatility concerns affecting micro-cap companies, potentially impacting investor sentiment.

HOUSTON, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW), today provided the following business update and letter to shareholders from its Chief Executive Officer, Mark White:

To our valued shareholders,

I would like to thank all of you for your tremendous support, as we look towards a very bright future in 2023 and beyond. Nexalin has built a solid foundation, grounded in strong intellectual property, and backed by growing clinical data.  Our goal has been and continues to be establishing the Company as the preeminent producer of innovative neurostimulation devices to uniquely and effectively help combat the ongoing global mental health epidemic.

Our first-generation (Gen-1) 4-milliamp frequency-based device was previously cleared by the U.S. Food and Drug Administration (FDA) to treat patients with anxiety, depression, and insomnia. However, with the evolution of our business and regulatory strategy, we have implemented important technology enhancements to our Gen-1 device and waveform. The enhancements will increase the waveform power from 4 milliamps to 15 milliamps. Nexalin believes that a stronger and more powerful waveform will allow deeper penetration in the brain and provide enhanced patient response without any adverse side effects. A new improved modern enclosure, referred to as Generation 2 (Gen-2), will administer the new waveform in a clinical setting. Additionally, the Nexalin design team has completed prototype designs for the new patient headset, referred to as Generation 3 (Gen-3). Nexalin is planning to present Gen-2 and Gen-3 to the FDA in Q1 2023 for the treatment of anxiety and insomnia. Strategic planning for a PMA with the FDA for the treatment of Major Depressive Disorder (MDD) is planned for Q3 2023. The strategy will be supported by a large blinded clinical trial with the Gen-3 headset.

Specifically, we are moving forward with conducting clinical trials of our Gen-2 and Gen-3 devices for various mental health disorders in the United States. Nexalin is seeking to expand our innovative neurostimulation devices to address the current mental health epidemic including substance use disorder (addiction),
Alzheimer’s, traumatic brain injury (TBI), PTSD and chronic pain.

Given the favorable results of recent safety data provided by the University of California San Diego, which supports the safety of utilizing our new waveform technology, we are excited to take the next step on this journey with a goal of bringing this new, effective, safe, and drug-free therapy to our patients with mental and neurodegenerative illnesses.

On the heels of the approval of our Gen-2 medical device by China’s National Medical Products Administration (NMPA) for insomnia and depression, we are making progress with the commercial rollout of our device in China through our joint venture partner, Wider Come Limited. We are currently making strategic plans for additional clinical trials for the use of Gen-2 and Gen-3 devices in China to scientifically validate the new advanced waveform.

Most recently, we announced the publication of a white paper, titled, “A case report of Nexalin Gen-2 device in the treatment of somatic symptoms of anxiety,” by the Second Xiangya Hospital of Central South University, China, validating our Gen-2 device for the treatment of generalized anxiety disorder and associated somatic (physical) symptoms. The patient, a 42-year-old female teacher, suffered repeated mental and physical discomfort for 23 years, as well as anxiety attacks and sleep disturbance. The treatment consisted of 2 treatments per day over 10 days. Notably, the hospital reported the disappearance of all somatic anxiety symptoms and improved quality of sleep. Nexalin believes this response to the patient’s somatic symptoms that originated from anxiety, demonstrates the potential of the new advanced waveform for the treatment of mental and physical symptoms associated with generalized anxiety disorder. As a result, we look forward to the results of new and current clinical trials.

In September 2022 we achieved a historic milestone for our Company by listing on the Nasdaq Stock Market and concurrently raising $9.6 million.  This financing puts us on solid footing to execute our strategy and we believe our listing on a major U.S. exchange provides us increased visibility, liquidity, and the opportunity to attract a broader investor base.  As a result, we believe we are well funded to support the clinical development, sales, and marketing activities around our innovative medical devices.  While we recognize the volatility in the stock market, especially among micro-cap companies, which has caused concern for many of our investors, we appreciate your continued support and remain confident the steps we have taken will drive significant long-term value for our shareholders.

Once again, let me take this opportunity to thank you, our shareholders, as well as our hard-working employees and our board of directors, for your faith, dedication, and support. We remain fully committed to executing on our business model and could not be more excited about the outlook for the business. We remain encouraged by the potential of our neurostimulation devices for improving healthcare outcomes among patients with mental and neurodegenerative illnesses as a proven alternative to psychiatric drugs. We look forward to providing further updates on our clinical research, and commercial programs as we continue to make progress heading into the new year. 

I look forward to the new year with great optimism, not only for our shareholders, but the countless patients whose lives we hope to change.

Best regards,
Mark White

About Nexalin Technology, Inc.

Nexalin designs and develops innovative neurostimulation products to uniquely and effectively help combat the ongoing global mental health epidemic. All Nexalin’s products are non-invasive and undetectable to the human body and provide relief to those afflicted with mental health issues without adverse side effects. Nexalin utilizes bioelectronic medical technology to treat mental health issues without the need for drugs or psychotherapy. Nexalin believes the 15 milliamp medical device can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper penetrating waveform will generate enhanced patient response without any adverse side effects. The Nexalin tACS device was recently approved in China by the National Medical Products Administration (NMPA) for the treatment of insomnia and depression. In September 2018, Nexalin entered into a series of agreements with Wider Come Limited (“Wider”), a company formed under the laws of the People’s Republic of China. Pursuant to this agreement, Nexalin and Wider have agreed to explore the formation of a joint venture entity to be domiciled in Hong Kong. This new entity will conduct clinical research and implement a business distribution plan for the Nexalin device in the Asia Pacific. 

Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020
Email: NXL@crescendo-ir.com

FAQ

What is Nexalin Technology's recent update regarding its neurostimulation devices?

Nexalin Technology updated on its enhancements to neurostimulation devices, notably increasing the waveform power of its Gen-1 device to 15 milliamps for better treatment outcomes.

When does Nexalin plan to submit its devices to the FDA?

Nexalin plans to submit its Gen-2 and Gen-3 devices to the FDA in Q1 2023.

What are the potential applications of Nexalin's devices?

Nexalin's devices aim to treat various mental health disorders, including anxiety, depression, PTSD, and substance use disorder.

How much funding did Nexalin raise from its Nasdaq listing?

Nexalin raised $9.6 million following its Nasdaq listing.

What recent validation did Nexalin receive for its Gen-2 device?

A white paper published by the Second Xiangya Hospital confirmed the Gen-2 device's effectiveness in treating anxiety and associated symptoms.