Nexalin Technology Appoints Medical Device Veteran Michael Nketiah as Senior Vice President of Quality, Clinical and Regulatory
24 Gennaio 2023 - 2:30PM
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, LLCTel: (212)
671-1020
Email: NXL@crescendo-ir.com
Grafico Azioni Nexalin Technologies (NASDAQ:NXL)
Storico
Da Mag 2024 a Giu 2024
Grafico Azioni Nexalin Technologies (NASDAQ:NXL)
Storico
Da Giu 2023 a Giu 2024