Press release

BrainScope Completes Large-Scale Clinical Studies of Concussion in Universities, High Schools and Concussion Clinics

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BrainScope®, a medical neuro-technology company focused on
concussion and mild traumatic brain injury (mTBI) assessment, announced
today that it had concluded both algorithm development and clinical
validation studies in adolescent and young adult populations using its
objective, EEG-based technology. The purpose of the studies was to
create and validate an objective, personalized capability for assessment
of concussion and readiness to return to activities in males and females
between the ages of 13-25. The studies conducted from 2015 through 2019
at 52 clinical sites included nearly 1,700 patients and healthy
controls, with over 4,000 evaluations. Funding sources for the studies
included a $9.9 million research contract from the U.S. Department of
Defense, award funding from the NFL-GE Head Health Challenge (in which
BrainScope was a two-time awardee), and BrainScope private funding.

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BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injur ...

BrainScope®, a medical neuro-technology company focused on concussion and mild traumatic brain injury (mTBI) assessment. (Photo: Business Wire)

“We are extremely pleased to have concluded these substantial clinical
studies over 4 years, the results of which are extremely exciting as we
work in the near-term through appropriate regulatory processes to bring
important new concussion assessment capabilities to the market,” stated
Michael Singer, CEO of BrainScope. “In particular I want to thank the
U.S. Department of Defense, the NFL, GE, and BrainScope investors for
their financial support of this major initiative which has yielded such
excellent results.”

In January, BrainScope announced that researchers had published
preliminary results related to a concussion assessment capability for
potential severity and likelihood of prolonged recovery from concussions
in the peer-reviewed journal Computers in Biology and Medicine.
The paper entitled, “A multimodal biomarker for concussion
identification, prognosis and management” describes a study which
enrolled 568 concussed and matched control patients between the ages of
13-25. Results from this study demonstrated highly significant
differences in the BrainScope EEG-based biomarker at the time of injury
between the 177 concussed patients and controls, and no significant
differences at when Return-to-Play was clinically determined.
Progressive recovery over time was also objectively demonstrated,
especially in the prolonged recovery group. Results also supported the
hypothesis that some of the more severely injured subjects may have been
allowed to return to play too soon.

“These large studies add important information to the understanding of
the pathophysiology of concussion, leading to better assessment
capabilities which can improve short and long-term outcomes of
head-injured patients,” added Leslie Prichep, PhD, Chief Scientific
Officer of BrainScope.

BrainScope’s flagship BrainScope One product, which is
commercially available today, is a multi-modal, comprehensive, handheld
capability to help clinicians objectively and rapidly assess and triage
head injured patients directly at the point of care. BrainScope One is
the first FDA-cleared medical device to offer capabilities to assess the
full spectrum of brain injury – from concussions (functional
abnormality) to brain bleeds (structural injury). BrainScope One is
currently being fielded by the U.S. military, both stateside and
internationally. BrainScope One is also being used in a
cross-section of market segments including: urgent care and occupational
health clinics; concussion clinics; hospital emergency rooms; university
sports and student health centers; professional sports; and
pharmaceutical clinical trials.

About BrainScope

BrainScope’s mission is to revolutionize the rapid and objective
assessment of brain-related conditions, starting with concussion and
mild traumatic brain injury, utilizing multiple integrated assessment
capabilities, artificial intelligence (AI) and digitization within a
culture of quality, excellence and entrepreneurialism. The Company’s
first product, BrainScope One, incorporates a multi-modal,
multi-parameter panel of assessment capabilities including EEG-based
technology that is non-invasive for mildly presenting head-injured
patients, 18-85 years old, within 3 days after injury and is not a
replacement to CT scan. BrainScope’s technology platform integrates
databases of thousands of brainwave recordings with AI technology and
miniaturized hardware and disposable headset sensors, all of which are
covered by an extensive intellectual property portfolio of over 100
issued and pending patents globally. BrainScope has received seven FDA
clearances and ISO 13485 Certification. It has 26 peer-reviewed
publications on its technology. Recent white papers authored by third
parties have shown the potential for BrainScope One to
decrease unnecessary head CT scans by one-third, to reduce head injury
referrals to hospital emergency departments by up to 75%, and to reduce
healthcare costs for insurers and patients by over 30%.

BrainScope has partnered with the U.S. Department of Defense (DoD) for
the development of its mTBI and concussion assessment technology.
BrainScope has been the recipient of several prestigious awards,
including the Frost & Sullivan 2017 Best Practices Award for New Product
Innovation in the Traumatic Brain Injury Assessment Solutions Market,
was a two-time winner of the GE-NFL Head Health Challenge, and has
received two nominations for the Prix Galien Best Medical Technology
(2017 and 2018), regarded as the equivalent of the Nobel Prize for
medical devices. BrainScope has received significant funding from
private investors including DBL Partners, Revolution (created by AOL
co-founder Steve Case), ZG Ventures and Maryland Venture Fund. For more
information, please visit www.brainscope.com.

The clinical study was supported in part by the U.S. Army Contracting
Command, Aberdeen Proving Ground, Natick Contracting Division, under
Contract No. W911QY-14-C-0098. Any opinions, findings and conclusions or
recommendations expressed in this material are those of the author(s)
and do not necessarily reflect the views of the US Army Contracting
Command, Aberdeen Proving Ground, Natick Contracting Division.