TIDMEGI
RNS Number : 6666A
Electrical Geodesics, Inc
28 March 2017
Electrical Geodesics, Inc.
Preliminary Results of the Epilepsy Trial
EUGENE, OREGON, US, 28 April 2017 - Electrical Geodesics, Inc.
("EGI" or the "Company"), a leading neurodiagnostic medical
technology company, today provides preliminary results of case
studies from the first three patients treated in its safety and
feasibility trial for suppressing focal epilepsy with Geodesic
Transcranial Electrical Neuromodulation (GTEN).
The patients in this trial at the University of Washington
Harborview Hospital in Seattle suffer from focal epilepsy (ie
epilepsy associated with a specific region of the brain) that is
not controlled by medication. The epileptic discharges reflect the
abnormal activity of the brain that is often associated with
generating seizures. Each of the three patients has demonstrated a
statistically significant suppression of epileptic discharges
immediately following treatment, where statistical significance is
measured by the change in the epileptic discharge rate (before
versus after treatment) across the five treatment days.
GTEN represents an advance in targeting brain regions for
electrical neuromodulation with a dense electrode array (256
channels) distributed over the head surface, and with high
performance computing applied to model the distribution of
electrical current in each patient's head tissues. EGI's
proprietary technology allows the use of the patient's dense array
electroencephalography ("dEEG") to guide the targeting of the
therapeutic pulses of electric current. GTEN is currently sold for
research use only and will require clearance from a regulatory body
such as the FDA in order to be sold for treatment of each specific
disorder, including epilepsy.
A preliminary report on the epilepsy trial results will be
presented at the Brain Stimulation and Imaging Symposium June 23-24
at the Organization for Human Brain Mapping meetings in Vancouver,
BC, Canada.
EGI would need to secure additional funding in order to advance
the clinical trial through to a pivotal study at the current centre
within the University of Washington, and to extend the trial to a
new site at Huashan Hospital of the Fudan University Shanghai
Medical College in Shanghai, China. Subject to funding being
secured, the goal would be to complete the recruitment of the
planned 20 patients in the feasibility study by year end 2017,
report the results to FDA, and plan for a pivotal trial commencing
in 2018.
Dr. Don Tucker, CEO of EGI, commented: "Although we have as yet
only assessed a small number of patients, these improvements
immediately following treatment support our hypothesis that
accurate targeting of epileptic regions of the brain with our GTEN
technology will allow reduction of cortical excitability and thus
suppression of epileptic discharges, at least acutely. For the
pivotal trial, we need to understand how lasting the effect is, and
whether it will result in suppression of seizures."
Dr. Mark Holmes, epileptologist and Principal Investigator of
the University of Washington trial, added, "These are exciting
results with very difficult patients. Even a temporary suppression
of seizure activity could be clinically significant for the 35% of
patients who continue to suffer from seizures despite taking
multiple anticonvulsant medications."
For more information contact:
EGI
Ann Bunnenberg +1 541 687 7962
Peel Hunt LLP (NOMAD
and Broker)
James Steel, Oliver +44 (0) 20 7418
Jackson 8900
Special Note Regarding Forward Looking Statements
All statements, other than statements of historical fact, are
forward-looking, including, without limitation, statements
regarding: future operating results; market conditions and
opportunities; timing and amount of expected shipments; growing
interest in EGI's core products; impact of new product releases and
clinical sites on sales; new products expected to provide
attractive growth opportunities; outcome of clinical trials and
their ability to assess safety and feasibility; reviewing potential
financing options and their ability to assist the Company in
maximizing its growth opportunities; confident about the prospects
for the second half of 2016 and double digit sales growth for the
full year. Words such as "believe," "anticipate," "expect,"
"estimate," "project," "will be," "will continue," "will likely
result," or words or phrases of similar meanings identify
forward-looking statements. Forward-looking statements reflect
management's current expectations, plans or projections and are
inherently uncertain and actual results could differ materially
from such expectations, plans or projections. Investors are
cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date of this press release.
Risks and uncertainties that could cause actual results to differ
significantly from management's expectations include, but are not
limited to, the following: EGI's limited financial and other
resources; potential period-to-period revenue or expense
fluctuations; production factors and timely access to raw
materials; industry cost factors and conditions; competition;
government regulation; labor disputes; technological changes; and
international business risks. Additional risks and uncertainties
not presently known to EGI or which EGI currently deems immaterial
also may impair its business or operations. EGI does not intend to
release publicly any revisions to any forward-looking statements
contained herein to reflect events or circumstances after the date
hereof or to reflect the occurrence of unanticipated events.
Notes to Editors
Electrical Geodesics, Inc. in Summary
Founded in 1992, EGI designs, develops and commercialises a
range of non-invasive neurodiagnostic and neuromodulation products
used to monitor, interpret and modulate brain activity, based on
its proprietary dense array electroencephalography ("dEEG")
platform technology. The Company's technology uses up to 256
sensors, providing much higher resolution brain activity data
compared to conventional 8 or 16 channel EEG and is used in
medical, clinical and research settings in a diverse range of
applications including important areas such as the diagnosis and
monitoring of epilepsy, neurosurgical planning, sleep assessment,
and many others.
EGI's dEEG systems, available in the GES 300 and now the GES 400
lines, capitalise on the Company's unique Hydrocel Geodesic Sensor
Net which allows faster, easier, and more convenient placement of
many EEG sensors in an even distribution over the entire scalp,
providing more accurate and precise diagnosis and measurement.
EGI's technology is now widely used in neuroscience research
laboratories and is becoming more commonly used in clinics, care
centers, and hospitals around the world. Data is measured and
visualised using EGI's proprietary amplifier technology and
software, providing a complete, advanced, high-resolution EEG
platform. The Company's products are compatible with multiple
diagnostic and imaging technologies, including magnetic resonance
(MR) imaging, functional MRI (fMRI), and magneto-encephalography
(MEG).
See our website www.egi.com
Glossary
EEG Electroencephalography
dEEG Dense-array EEG
GTEN Geodesic transcranial electrical
neuromodulation
GS3 GeoSource 3
MRI Magnetic resonance imaging
fMRI Functional MRI
PET Positron emission tomography
MEG Magneto encephalography
NIRS Near-infra-red spectroscopy
TES Trans-cranial electrical
stimulation
TMS Trans-cranial magnetic stimulation
rTMS repetitive Trans-cranial
magnetic stimulation
This information is provided by RNS
The company news service from the London Stock Exchange
END
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