Nexalin Technology Appoints Medical Device Veteran Michael Nketiah as Senior Vice President of Quality, Clinical and Regulatory

Rhea-AI Summary

Nexalin Technology announced the appointment of Michael Nketiah as Senior Vice President of Quality, Clinical, and Regulatory. Nketiah brings over 23 years of experience in regulatory affairs and clinical operations, specifically with the FDA. His expertise will support the company in accelerating FDA clearance for its Generation 2 and Generation 3 neurostimulation devices, aimed at improving healthcare outcomes for mental and neurodegenerative illnesses. The Gen-2 device is designed to penetrate deeper into the brain using an advanced waveform, while the Gen-3 prototype will utilize a virtual-clinic model for treatment.

Positive

• Appointment of Michael Nketiah enhances leadership with his extensive regulatory and clinical experience.
• The Gen-2 device's improved capabilities may lead to better treatment outcomes for patients with mental health issues.

Negative

• Concerns about FDA approval timelines for the new devices may affect investor confidence.

HOUSTON, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW), today announced the appointment of Michael Nketiah as Senior Vice President of Quality, Clinical and Regulatory.

Mr. Nketiah is an expert in regulatory affairs, as well as clinical and quality assurance, specializing in US FDA and international regulatory approvals, with over 23 years of experience working directly with the FDA in the medical device and life sciences industries, for both prescription and OTC products. His experience includes multiple regulatory submissions of 510(k)s, PMAs, De Novo, IDEs, Q-Submissions, FDA meetings and international regulatory approvals for a wide variety of innovative and novel medical device and in vitro diagnostic device companies. His experience includes developing quality systems, authoring various US FDA regulatory submissions, and assisting with clinical operations. Mr. Nketiah also has extensive experience in gaining US and international approvals for clinical investigations and/or product launch in Europe, North America, Australia/New Zealand, and Asia. Prior to joining Nexalin, Mr. Nketiah served in senior roles at various companies which include VP of Quality & Regulatory Affairs at Intervenn Bioscience, Tivic Health, Previvo Genetics, Sr. Director of Quality and Regulatory Affairs at PROCEPT BioRobotics, Director of Quality at Crux Biomedical, Inc. and at Biomimedica, Inc. Michael holds two Bachelor of Science degrees in Chemistry and Mechanical Engineering, and an MBA degree.  

Mark White, CEO of Nexalin Technology, noted, “We are pleased to welcome Michael to our senior leadership team. He brings extensive program management, clinical development and regulatory experience, which should be invaluable as we accelerate our efforts to obtain FDA clearance/approval of our Generation 2 (Gen-2) and Generation 3 (Gen-3) neurostimulation devices, that we believe will significantly improve healthcare outcomes among patients with mental and neurodegenerative illnesses as an alternative to psychiatric drugs. Our Gen-2 device, with a new and improved modern enclosure, as well as an advanced waveform to be emitted at 15 milliamps, is designed to penetrate deeper into the brain to stimulate structures associated with mental illness for enhanced patient response. We are also advancing the clinical development of our Gen-3 prototype, a new patient headset for the treatment of anxiety and insomnia that will utilize a virtual-clinic model and can be performed from the privacy of the patient’s home, while reducing costs for patients and doctors. Having a widely respected clinical expert of Michael’s caliber will assist us in advancing clinical trials of our Gen-2 and Gen-3 devices in the United States as we seek to expand our innovative neurostimulation devices into new indications, such as substance use disorder (addiction), Alzheimer’s, traumatic brain injury (TBI), PTSD and chronic pain. Michael has a proven track record launching new commercial products, and we look forward leveraging his skill set in order to bring our new, effective, safe, and drug-free therapy to patients with mental health issues in the United States, China and around the world.”

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 region. Additional information about the Company is available at: https://nexalin.com/.

FORWARD-LOOKING STATEMENTS

This press release contains statements that constitute "forward-looking statements," including with respect to the Company’s initial public offering. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company, including those set forth in the Risk Factors section of the Company's registration statement and prospectus for the offering filed with the SEC. Copies are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.

Contact:
Crescendo Communications, LLC
Tel: (212) 671-1020

Email: NXL@crescendo-ir.com

FAQ

Who is Michael Nketiah in relation to Nexalin Technology?

Michael Nketiah has been appointed as Senior Vice President of Quality, Clinical, and Regulatory at Nexalin Technology.

What is the significance of Michael Nketiah's appointment?

His extensive experience in regulatory affairs and clinical operations is expected to accelerate FDA approval for Nexalin's new neurostimulation devices.

What are the Generation 2 and Generation 3 neurostimulation devices?

The Gen-2 device is designed for deeper brain penetration to enhance treatment outcomes, while the Gen-3 prototype will offer treatment through a virtual clinic model.

When did Nexalin Technology announce this leadership change?

Nexalin Technology announced Michael Nketiah's appointment on January 24, 2023.

What are the expected impacts of the new devices on mental health treatment?

The devices aim to provide effective, non-invasive alternatives to psychiatric drugs for various mental and neurodegenerative conditions.