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Nexalin Technology Appoints Medical Device Veteran Michael Nketiah as Senior Vice President of Quality, Clinical and Regulatory
HOUSTON, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Nexalin Technology, Inc. (the “Company” or “Nexalin”) (Nasdaq: NXL; NXLIW), today announced the appointment of
About this update from Nexalin Technology, Inc.
[{"type":"text","content":"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 advanc...