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Preliminary Results of the Epilepsy Trial

28 Mar 2017 07:00

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 Jackson

+44 (0) 20 7418 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

GTEN

Dense-array EEG

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
 
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