Veteran medical device executive to drive regulatory and clinical strategy as Nexalin advances drug-free Deep Intracranial Frequency Stimulation (DIFS) technology for mental health treatment
HOUSTON, TX, Oct. 14, 2024 (GLOBE NEWSWIRE) — Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) (the “Company” or “Nexalin”) announces the appointment of Carolyn Shelton as Senior Vice President of Clinical, Quality & Regulatory Affairs. With more than 30 years of experience in the medical device industry, Shelton brings a wealth of knowledge in regulatory compliance, quality assurance, and clinical development. In her role, she will oversee all clinical studies, quality systems, and regulatory submissions, ensuring Nexalin’s commitment to innovation, safety, and excellence as the Company prepares to pursue global regulatory clearances and future FDA Breakthrough Device designations for its cutting-edge Deep Intracranial Frequency Stimulation (DIFS) technology.
Shelton’s impressive career spans leadership positions at globally recognized companies. At Openwater Health, LLC, she served as Vice President of Regulatory, Quality, and Clinical, where she was instrumental in building the regulatory and clinical framework from the ground up for a medical device start-up, filing for FDA Breakthrough designation, and leading early feasibility clinical trials. Prior to this, at Advanced Sterilization Products, Inc. (ASP), a division of Fortive, she was Vice President of Worldwide Regulatory, Quality, Medical Affairs, and Product Stewardship. In that role, Shelton led the global integration of ASP following its divestiture from Johnson & Johnson, developed strategic regulatory plans, and successfully guided the company through multiple regulatory submissions and audits, including achieving compliance with the EU MDR. At Medtronic, as Vice President of Regulatory, Quality, Medical Affairs, and Clinical, she directed regulatory strategy and managed regulatory submissions for a diverse portfolio of medical devices, ensuring successful global approvals while driving quality improvements across the organization. Earlier in her career, Shelton held various leadership positions at Smith & Nephew, where she played a pivotal role in developing global regulatory strategies and ensuring compliance for a wide range of Class I, II, and III devices, biologics, and combination products.
Commenting on the appointment, Mark White, CEO of Nexalin Technology, said, “We are delighted to welcome Carolyn to our executive team at such an exciting time for Nexalin. Her deep experience in successfully navigating complex global regulatory landscapes and leading high-performing teams is truly impressive. Carolyn’s leadership in preparing regulatory submissions such as 510(k), PMA, and breakthroughs her extensive work in achieving EU MDR compliance, and her ability to manage clinical trials will be invaluable to Nexalin as we move forward. In particular, Carolyn’s proven ability to guide companies through global regulatory clearance processes will be crucial as we prepare for the international rollout of our DIFS technology and pursue future FDA Breakthrough Device designations. Carolyn is a strategic addition, and we look forward to her contributions in driving Nexalin’s growth and innovation.”
Shelton added, “I’m excited to join Nexalin at this pivotal time, especially given the huge unmet need for effective, drug-free alternatives to treat mental illness. Mental health conditions such as anxiety, depression, and insomnia not only affect the lives of patients but also have a profound impact on their families. Nexalin’s innovative DIFS neurostimulation technology offers a much-needed solution for individuals seeking treatment without the side effects of medication. With Nexalin preparing to undertake major regulatory initiatives, both in the U.S. and internationally, I’m eager to bring my experience to the table and help navigate these critical processes. I look forward to working with the Nexalin team to bring these potentially transformative therapies to market, ultimately improving the quality of life for countless patients and their loved ones.”
About Nexalin Technology, Inc.
Nexalin designs and develops innovative neurostimulation products to uniquely help combat the ongoing global mental health epidemic. All of Nexalin’s products are believed to be non-invasive and undetectable to the human body and are developed to provide relief to those afflicted with mental health issues. Nexalin utilizes bioelectronic medical technology to treat mental health issues. Nexalin believes its neurostimulation medical devices can penetrate structures deep in the mid-brain that are associated with mental health disorders. Nexalin believes the deeper-penetrating waveform in its next-generation devices will generate enhanced patient response without any adverse side effects. The Nexalin Gen-2 15 milliamp neurostimulation device has been approved in China, Brazil, and Oman. Additional information about the Company is available at: https://nexalin.com/.
FORWARD-LOOKING STATEMENTS
This press release contains statements that constitute “forward-looking statements,” These statements relate to future events or Nexalin’s future financial performance. Any statements that refer to expectations, projections or other characterizations of future events or circumstances or that are not statements of historical fact (including without limitation statements to the effect that Nexalin or its management “believes”, “expects”, “anticipates”, “plans”, “intends” and similar expressions) should be considered forward looking statements that involve risks and uncertainties which could cause actual events or Nexalin’s actual results to differ materially from those indicated by the forward-looking statements. 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 Report on Form 10-K for the year ended December 31, 2023 and other filings as filed with the Securities and Exchange Commission. Copies of such filings are available on the SEC’s website, www.sec.gov. Such forward-looking statements are made as of the date hereof and may become outdated over time. Such forward-looking statements are made as of the date hereof and may become outdated over time. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
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