Neural Analytics Enrolls First Patient in Clinical Study to Evaluate Transcranial Doppler Analytical Platform for Monitoring of Mild Traumatic Brain Injury

LOS ANGELES–(BUSINESS WIRE)–Neural Analytics Inc., a medical device company developing and
commercializing technology to measure, diagnose and track brain health,
today announced the company’s enrolled its first patient in a two-year
study to develop a method for evaluating cerebral blood flow in patients
with mild traumatic brain injury (TBI) using its Lucid M1 Transcranial
Doppler (TCD) Ultrasound System™. The Lucid System is an all-in-one
ultrasound system designed for measuring and displaying cerebral blood
flow velocities of patients with brain disorders.

Researchers at the University of California Los Angeles (UCLA) Steve
Tisch BrainSPORT Program will divide the study’s 240 subjects from Los
Angeles area high schools and colleges into three groups. These groups
include individuals who have been affected by mild TBI, “In Sport”
controls (high-risk contact sports, i.e. football and hockey) and “Out
of Sport” controls (low-risk contact sports, i.e. baseball and tennis).

The study is designed to include both acute analysis after injury and
return-to-participation (RTP) components. This will support the
development of a new objective method for quantification of well-known
physiologic changes after a mild TBI, such as impairment of autonomic
function and altered cerebral blood flow (CBF). The study will compare
cerebral hemodynamic impairment measured with Neural Analytics’ Lucid
System to clinical evaluations and magnetic resonance imaging (MRI)
techniques.

“Understanding the pathophysiology of a concussion is very important to
treating patients in a timely fashion,” said Christopher Giza, MD, a
neurologist and Sub-Investigator of the study. “The findings of this
study can potentially help us identify the subtle changes that aren’t
easily detected using current diagnostic methods in treating and
managing individuals with mild TBI.”

Current mild TBI diagnostic methods and RTP assessments are based on
patient symptoms, neurocognitive evaluations and/or physical tests. They
are not suitable for a significant majority of mild TBI patients because
patient symptom assessments are subjective and variable, while
neurocognitive evaluations and physical tests require a pre-injury
baseline not usually available.

“There’s a need for a definitive method for mild TBI assessment, in
particular for determining if a patient is ready to return to playing
after a sports concussion, especially in high school and college
athletes,” said Robert Hamilton, Ph.D., PI of the study, Co-Founder and
Chief Scientific Officer of Neural Analytics. “Findings from this study
may help inform physicians on return to play decisions.”

The rate of concussions in high school and colleges is reported to be as
high as 1.5 and 3 per thousand events respectively in the U.S.1

Globally, each year, severe blood flow disorders affect more than 30
million people. TBI and stroke contribute the most to the global disease
burden for these disorders. There are 14.8 million people affected by
TBI worldwide annually, with 2.5 million in the United States.2,3

Meeryo Choe, M.D., the Associate director of UCLA Steve Tish BrainSPORT
Program, will also serve as the site Principal Investigator in this
study.

The study is part of a $3 million grant Neural Analytics received from
the National Institutes of Neurological Disorders and Stroke of the NIH
Award #R44NS092209. Research reported in this publication was supported
by the National Institute Of Neurological Disorders And Stroke of the
National Institutes of Health under Award Number R44NS092209. The
content is solely the responsibility of the authors and does not
necessarily represent the official views of the National Institutes of
Health.

About Lucid M1 Transcranial Doppler Ultrasound System™ (Lucid System)

Neural Analytics’ Lucid M1 Transcranial Doppler Ultrasound System™
(Lucid System), FDA cleared and CE marked, is an all-in-one ultrasound
system designed for measuring and displaying cerebral blood flow
velocities and monitoring of patients with brain disorders. The Lucid
System is a battery operated medical grade tablet device. It uses a type
of ultrasound called Transcranial Doppler (TCD) to assess the brain’s
blood vessels from outside the body. This analysis can be performed in
the physician’s office, and can help the physician diagnose brain
disorders, potentially without the need for additional, more invasive
tests. Many significant brain disorders are caused by blood flow
disruption.

About Neural Analytics Inc.

Neural Analytics was founded in 2013 to create products and services to
measure, diagnose and track brain health. They combine leading data
science with cutting edge hardware to allow first responders and
clinicians to accurately assess and monitor brain health issues. Their
devices are designed to be portable, autonomous, reliable, and produce
precise and objective physiological measurements for medical responder
monitoring of neural disorders. More information is available at http://www.neuralanalytics.com.

Sources:

1. Daneshvar, “NIH Public Access,” Clin Sport. Med., vol. 30, no. 1, pp.
1–17, 2011.

2. http://www.cdc.gov/traumaticbraininjury/severe.html

3. Bryan-Hancock, C. et. Al.The global burden of traumatic brain injury:
preliminary results from the Global Burden of Disease Project. Inj Prev
2010;16:A17 doi:10.1136/ip.2010.029215.61

Contacts

Neural Analytics Inc.
Henry Hewes, +1-949-239-2018
Global
Vice President, Sales and Marketing