Nexalin Technology, Inc. (Nasdaq: NXL; NXLIW) is thrilled to welcome Michael Nketiah to its leadership team as Senior Vice President of Quality, Clinical and Regulatory. With his vast experience and expertise in the field, Michael is poised to help propel the Company to the next level of success.
Mr. Nketiah is an internationally-renowned expert in regulatory affairs and quality assurance, boasting 23 years of experience assisting with the US FDA and other international regulatory approvals for medical devices and in vitro diagnostic devices. His impressive background includes developing quality systems, authoring numerous regulatory submissions, and assisting with clinical operations. He has also helped numerous innovative and novel medical device companies gain US and international approvals for clinical investigations and product launches in Europe, North America, Australia/New Zealand, and Asia. Mr. Nketiah holds two Bachelor of Science degrees in Chemistry and Mechanical Engineering, as well as an MBA degree, and has previously served in senior roles at various organizations, such as VP of Quality & Regulatory Affairs at Intervenn Bioscience, Tivic Health, Previvo Genetics, and Sr. Director of Quality and Regulatory Affairs at PROCEPT BioRobotics, to name a few.
We are excited to announce the addition of Michael to our senior leadership team and the invaluable contribution that he will make to our organization. Michael brings with him an abundance of program management, clinical development, and regulatory experience that will be of great use as we continue to strive to obtain FDA clearance/approval for our Generation 2 (Gen-2) and Generation 3 (Gen-3) neurostimulation devices. Our Gen-2 device, with its modern enclosure and advanced waveform, is designed for deeper penetration of the brain and to stimulate structures associated with mental illness for enhanced patient response. We are also working on the development of our Gen-3 prototype, a new patient headset for the treatment of anxiety and insomnia that will be provided through a virtual-clinic model and can be done in the privacy of the patient’s home, while reducing costs. Michael’s expertise will be invaluable in advancing clinical trials of our Gen-2 and Gen-3 devices in the United States. His experience in launching new commercial products will be a great asset in bringing our innovative, drug-free therapy to patients with mental health issues in the United States, China, and around the world.
About Nexalin Technology, Inc.
Nexalin is leading the fight against the global mental health epidemic, providing non-invasive, undetectable solutions that don’t come with harmful side effects. Using bioelectronic medical technology, Nexalin is able to provide relief to those suffering from mental health issues without the need for drugs or psychotherapy. Recently, their tACS device was approved in China by the National Medical Products Administration (NMPA) for the treatment of insomnia and depression. In order to further expand their reach in the Asia Pacific region, Nexalin has entered into a series of agreements with Wider Come Limited to explore the formation of a joint venture entity domiciled in Hong Kong. Through this new entity, Nexalin and Wider will conduct clinical research and devise a business distribution plan for the Nexalin device.