Item
2.01 Completion of Acquisition or Disposition of Assets.
The
information set forth in Item 1.01 of this Current Report on Form 8-K is incorporated herein by reference.
As
described in Item 1.01 above, effective September 1, 2016, the Company entered into a Share Exchange Agreement which resulted
in Nexalin becoming our majority-owned subsidiary.
Nexalin,
a Nevada corporation, was formed in October 2010. The Company is an information technology company which provides a safe, non-invasive
and drug free treatment that is cleared by the FDA for the treatment of anxiety, depression and insomnia. The Nexalin device emits
a patented, frequency-based waveform that interacts with structures of the mid-brain that help to regulate and stabilize neurochemicals.
Nexalin
products/treatments (“Nexalin Therapy”) is classified at the FDA as “Cranial Electrical Stimulation”.
Nexalin Therapy is a class III medical device and is FDA cleared and indicated for the treatment of depression, anxiety and insomnia.
These are also the symptoms associated with more complex issues such as PTSD, substance abuse and other addictive behaivors. Nexalin
has also received the CE European clearance for the treatment of chronic pain in addition to Anxiety, Depression and Insomnia.
Unfortunately
most mental health treatment models are based on the symptomatic treatment associated with pharmaceutical medication. Recently
new evidenced based articles have published statements that many of these medications have an actual effective rate of less than
30%. Additionally, there are many unpleasant side effects and addictive qualities associated with medications. The future of mental
health treatment is based on stimulating areas of the brain that may be responsible for the underlying cause of these disorders.
With the advancement of neuro-imaging techniques in the last 10 years, new evidence has indicated that many of the underlying
causes of mental health challenges can be identified in the mid-brain. This is the area that Nexalin has focused their advanced
stimulation technology.
Nexalin
Therapy utilizes a new patented waveform that is highly effective in stimulating the Hypothalamus and other structures in the
mid-brain associated with mental health issues. Data suggests the Nexalin Therapy waveform effectively resets these structures
of the brain without the introduction of pharmaceutical medication. A major function of the hypothalamus is to maintain homeostasis
in the brain by constantly sensing and adapting to information received by the brain. When an individual is faced with a traumatic
life event, the hypothalamus appears unable to maintain normal levels of Serotonin, Dopamine, Beta-endorphins and other Neurotransmitters.
The result of reduced levels of these important neurochemicals can be anxiety, depression, and insomnia and other related mental
health issues. All of which can increase in frequency and severity if not treated. The Nexalin Therapy treatment stimulates the
brain with an undetectable electrical frequency that is transmitted via a proprietary waveform. The waveform affects key brain
structures that are involved in the regulation of its neurotransmitters.
Nexalin
Therapy has an effective rate of over 70% in patients in company testing and research. Patients report an average reduction of
81% to 85% for their primary and secondary symptoms. Clinical results and early research indicates that 10-15 treatments will
begin stabilizing the brain by normalizing the levels of various neurotransmitters by increasing the production of Beta-endorphins.
Early research indicates base line beta-endorphin concentration of the Cerebral Spinal Fluid (CSF) was 1.5 times lower than that
of normal healthy subjects. After 40 minutes of the Nexalin Therapy stimulation, the average CSF beta-endorphin concentrations
increased 380%. Additional research indicates the effects are long lasting and addresses the underlying causes of the associated
symptoms. Nexalin Therapy consists of 10 - 15 consecutive daily treatment sessions which last 40 minutes. Nexalin Therapy is administered
non-invasively to the patient via three electrodes, one placed on the forehead and one placed behind each ear located on the mastoid
area of the temporal bone. The therapy itself delivers a mild, unique frequency based waveform that is administered through the
electrodes into the mid brain. Through this repetitive stimulation of the hypothalamus, Nexalin Therapy can trigger significant
changes in the levels of important neurochemicals within the brain. We believe that Nexalin Therapy assists the hypothalamus to
re-establish and sustain normal levels of neurochemicals in the brain.
Nexalin
Therapy is currently being used in several settings around the country. We believe that Nexalin Therapy provides benefit for patients
that are not responding to traditional pharmaceutical intervention or want to decrease dosage over time and reduce side effects.
We believe that Nexalin Therapy is also demonstrating tremendous opportunity in the addiction community by reducing the symptoms
associated with addiction such as anxiety and depression. By addressing these symptoms, Nexalin Therapy is also decreasing the
cravings issue associated with chronic relapse. Relapse conditions and mid-brain functional issues associated with active addictions
are mitigated by the normalization of the brain’s neurochemistry.
Nexalin’s
Management Team consists of:
Randall
Letcavage – Chief Executive Officer, President, Chief Financial Officer and Chairman of the Board of Directors
Mr.
Letcavage was named Chairman, President, Chief Executive Officer, and Chief Financial Officer of the Company on June 28, 2017.
Mr. Letcavage has been the Chief Executive Officer of Nexalin since inception in 2010. Mr. Letcavage is also Chairman, President,
Chief Executive Officer, and Chief Financial Officer of Premier Holding Corporation, since July 5, 2012. Prior to this he was
employed as a consultant by Capital Finance LLC. He brings in excess of 25 years plus of business experience specializing in the
financial markets and business consulting including biotech, green energy/clean technology. For the past 20 years Mr. Letcavage
has been an investment banker widely recognized for individual achievements as well as his role of Founder, Officer and Director
of the iCapital Group that includes iCapital Finance Inc, iCapital Advisory LLC and iCap Development LLC (A National “CDE”
Community Development Entity – Certified by the U.S Treasury Department). Mr. Letcavage has also held executive positions,
invested, and/or operated numerous businesses including related companies in life sciences, medical devices and green energy and
power reduction – CEO of Ciralight Global Inc, CEO of Green Central Holdings, Consultant and one of the largest shareholders
of publicly traded PRHL which operates The Power Company, American Illuminating and Energy Efficiency Experts (E3). Letcavage
had been successful in many areas additionally providing capital to healthcare companies. Mr. Letcavage personally acted as an
advisor to municipalities, including the Stare of New Jersey and its Economic Development Authority, and leading millions in industrial
bond transactions, as well as New Market Tax Credits, while also advising the National Conference of Black Mayors (NCBM; over
800 members in these matters). Mr. Letcavage served as the Managing Director of NC Capital Markets and as Vice President of The
National Capital Companies, Inc. (directing the daily operations of most of its subsidiaries). Mr. Letcavage was formerly the
CEO and a majority owner of Capital Access Group. Prior to Capital Access, Mr. Letcavage founded and/or managed several asset
management firms, including Valley Forge Capital Holdings and the Marshall Plan, LLC that directed and/or co-managed over $3 billion
in assets with former renowned CALPERS (California Pension & Retirement Systems) Manager, Greta Marshall. Prior to Valley
Forge, Mr. Letcavage founded Security America, Inc., an asset management firm based in Grosse Pointe, Michigan. Mr. Letcavage
worked with Prudential-Bache running a Joint Venture ―High Net Worth Group (a/k/a Security American, Inc.).
Mark
White
Chief
Operating Officer
Mark
has been a successful entrepreneur for 20 years; he specializes in the performance of service based companies. He has extensive
experience in growth organizations and turnaround situations. He has had numerous successes building teams and implementing effective
processes, with an emphasis on organizational development, financial stability and the quality and efficiency of services.
Mr.
White has spent the last six years studying the Nexalin Technology in the patient and practitioner community. In 2010, Mr. White’s
distribution company, iiCOM Strategic, became the first national distribution provider for Nexalin. His recent development of
clinical models utilizing the Nexalin Therapy has positioned him as a provider of consulting aspects related to the use of Nexalin
in clinical applications across the United States.
In
January of 2012, Mr. White joined the Nexalin corporate team to oversee operations and the development of a successful clinical
model. Mr. White is an experienced and well-respected trainer and presenter internationally on the subject of “Brain Based
Health” and “Brain Based Recovery”. He is a thought leader in the application of brain stimulation and its ability
to address mental health and addiction issues in the United States. Mr. White has also appeared on several prominent news and
media shows speaking on Nexalin and electrical brain stimulation as a form of drug free treatment for various psychiatric disorders.
In
addition to his considerable responsibilities with Nexalin, Mr. White is the Founder and Director of Unique Mind Care in Houston,
TX, a clinical leader in the in the brain health arena focused on drug free treatments that utilize QEEG training technologies
and various neurostimulation techniques.
Medical
Advisory Board
Nexalin
also utilizes a Medical Advisory Board, consisting of the following medical professionals:
Dr.
Mark G. Agresti, M.D. P.A.
Dr.
Agresti was raised in New Jersey and came to Florida after completing medical training. He attended Tulane University in New Orleans,
LA for premed. The Chicago Medical School for medical school, and completed his Residency in Psychiatry at Roosevelt Hospital
in New York City. He is Board Certified in the Practice of Psychiatry.
He
has been in private practice in West Palm Beach, FL for 20 years and has been on the staff of Columbia Hospital and several Addiction
Treatment centers. He served as Chairman of the Department of Psychiatry at Columbia Hospital and medical director for the various
treatment centers.
Dr
Agresti’s practice focuses on the treatment of mental illness addictions and dual diagnosis. He has expanded his addictions
practice to include outpatient detoxification from both drugs and alcohol. His patient population includes both children and adults.
Suzie
Schuder, MD
Dr.
Schuder is Board Certified by the American Board of Psychiatry and Neurology. She is a founding member and vice president of the
World Society of Antiaging Medicine (WOSAAM), a founding member of the International Hormone Society, and a member of the International
Society of Psychoneuroendocrinology (ISPNE), and the American Society of Addiction Medicine and a Diplomate of the American Board
of Anti-Aging Medicine.
Dr.
Schuder has made it her mission to educate doctors about her common-sense methods in providing a holistic, pro-health approach
to patient care, particularly in psychiatry . She also devotes time to lecturing physicians at a variety of international venues
on topics related to the mind and emotions and the major life altering impact of hormones, nutrients and toxins. Dr. Schuder also
takes the time to teach medical students who rotate through her unique psychiatric practice.
Dr.
Schuder provides total patient care through a balanced treatment approach by merging the best of traditional medicine with science-based
alternative solutions to provide excellence in patient care. She recently added a Nexalin, a unique transcranial electrostimulation
device that provides significant, enduring improvements in patients with depression, anxiety and insomnia.
Irene
Cergnul, MD
Dr.
Irene Cergnul completed her post-graduate training at Bronx Lebanon Hospital Center in New York and after her final year as Chief
Resident was recruited as Assistant Professor in the Department of Family Medicine. She worked as the Medical Director in the
in-patient service and also taught residents in training for the next four years. She was a Research Coordinator involving multiple
studies on HIV, depression, as well as neuropathy, and is a co-author on several publications.
Dr.
Cergnul then transitioned to Montefiore Medical Center at the Substance Abuse Treatment Program where she provided direct medical
care to patients, as the Director of HIV Services, and also held Assistant Professorship positions in both the Departments of
Family Medicine and Psychiatry. She taught Family Medicine residents, Psychiatry residents and fellows in Addiction Psychiatry.
Dr.
Cergnul is Board Certified in Family medicine as well as Addiction Medicine and is currently the Medical Director at Turning Point
addiction treatment facility in North Jersey. She has been involved with the field of addiction medicine, HIV care and Psychiatry
for the last 12 years. Her private practice focuses on novel modalities used in treating addiction and dual diagnosis patients,
both adolescent and adults.
Nancy
E. White, Ph.D.
Dr.
White is the Clinical Director of Unique MindCare in Houston, Texas. She is recognized as an industry leader in the development
of a brain based approach to support neurobehavioral wellness. Dr. White has specialized in the diagnosis and treatment of functional
brain disorders for more than twenty years. She is a Fellow, past President and Board member of the International Society for
Neurofeedback and Research (ISNR), a Certified EEG Fellow of the Biofeedback Certification International Alliance (BCN) and a
QEEG Diplomate and member of the Quantitative EEG Certification Board. Dr. White is a licensed Clinical Psychologist in the State
of Texas as well as a Licensed Marriage and Family Therapist and Advanced Addictions Counselor.
Dr.
White is a pioneer in the practical application of neuroscientific research to clinical practice, including the extension of advanced
brain based therapies to all psychiatric mood disorders including Post-Traumatic Stress, Autism and Addictions. She is a frequent
presenter of her work at conferences, including the American Academy of Anti-Aging Medicine, the International Society for Neurofeedback
and Research, the Association for Applied Psychophysiology and Biofeedback, FutureHealth, and the National Academy of Neuropsychology.
She also serves as a consulting editor of the Journal of Neurotherapy (Taylor and Francis).
Dr.
White has dedicated 3 years to the development of the clinical application of the Nexalin Therapy. Her research and clinical data
on the use of Nexalin Therapy has been presented at International conferences.
Benjamin
V. Hu, MD
Dr.
Hu is currently in private practice, with a specialty in General Ophthalmology, which consists of both medical and surgical aspects
including use of lasers, in Parma, Ohio: He is also a member of the Board of Directors and an Advisor to Enlighten Technologies
Inc. of Laguna Hills California, a company developing a surgical machine for cataract surgery with newly patented technology.
Dr.
Hu previously was a member of the NRAGT Board of Advisors, a parent advocacy group trying to increase classes, programs and clubs
to challenge the gifted, talented kids of North Royalton, Ohio; a Member of the Board of Advisors of QMS Inc., a company manufacturing
and marketing scale control systems and technology to business and industry in Cleveland, Ohio; and Co-Director of Ion-X International,
LLC in Huron, Ohio, a company manufacturing, marketing and distributing copper/silver ionization systems and technology to business
and industry.
Dr.
Hu was awarded his Chemical Engineering degree in June, 1979 in conjunction with the MIT School of Chemical Engineering Practice,
Cambridge, Massachusetts, with an emphasis on practical problem solving and independent research projects. Dr. Hu was awarded
his Doctorate of Medicine in May, 1983 from Case Western Reserve in Cleveland, Ohio, with an emphasis in applied medical research.
Dr. Hu did his Post-Doctorate Resident training in ophthalmology at the Kresge Eye Institute, Wayne State University, Detroit,
Michigan. He is the co-developer of a PCL implantation technique in the absence of capsular or zonular support. His technical
paper won the First Prize in the Kresge Residence Day competition for best research project and presentation.