Electrical Geodesics, Inc. Release: Feasibility Study Of GTEN 100 Neuromodulation In Epilepsy
EUGENE, OREGON, US, 2 October 2014 – Electrical Geodesics, Inc. (“EGI” or the “Company”), a leading neurodiagnostic medical technology company, today announces it will commence first clinical studies of its GTEN 100 transcranial electrical neuromodulation system in early 2015.
The initial study will assess the feasibility of use of the GTEN 100 in temporary seizure suppression in patients with drug-resistant epilepsy using both pulsed and sustained protocols. The goal of the feasibility study is to demonstrate a decrease in the excitability of the cortex at the site of seizure onset, as evidenced by fewer interictal epileptiform discharges (spikes). A consortium of leading epilepsy centres will participate in the study, including the University of Washington Harborview Hospital, Seattle, Harvard Medical School Beth Israel Deaconess Hospital, Boston, and Stanford University Hospital, Palo Alto and Huashan Hospital, Shanghai.
The details of the planned feasibility study will be refined following a pre-submission review by the US Food and Drug Administration, with the goal of evaluating the safety, comfort, and efficacy of the dense array (256-channel) electrical neuromodulation treatment in epilepsy patients. Future pivotal studies would follow the feasibility study in order to gain FDA approval for a GTEN 100 treatment protocol in epilepsy.
Don Tucker, PhD, Chairman and CEO of EGI, said:
“We are highly encouraged by the support we have received from these key international epilepsy centres. We believe our technology will have an important place in the suppression of seizures in patients who do not respond to drug treatments and that this represents an important first step in bringing GTEN 100 to market. We plan to investigate the use of our neuromodulation technology in a number of other important indications, such as depression, building on the results of this first feasibility trial.”
For more information contact:
EGI
UK: Christine Soden, CFO
+44 (0) 7710 484199
Peel Hunt LLP (NOMAD and Broker)
+44 (0) 20 7418 8900
James Steel, Clare Terlouw
FTI Consulting (PR Advisors)
+44 (0) 20 3727 1000
Simon Conway, Mo Noonan
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
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The initial study will assess the feasibility of use of the GTEN 100 in temporary seizure suppression in patients with drug-resistant epilepsy using both pulsed and sustained protocols. The goal of the feasibility study is to demonstrate a decrease in the excitability of the cortex at the site of seizure onset, as evidenced by fewer interictal epileptiform discharges (spikes). A consortium of leading epilepsy centres will participate in the study, including the University of Washington Harborview Hospital, Seattle, Harvard Medical School Beth Israel Deaconess Hospital, Boston, and Stanford University Hospital, Palo Alto and Huashan Hospital, Shanghai.
The details of the planned feasibility study will be refined following a pre-submission review by the US Food and Drug Administration, with the goal of evaluating the safety, comfort, and efficacy of the dense array (256-channel) electrical neuromodulation treatment in epilepsy patients. Future pivotal studies would follow the feasibility study in order to gain FDA approval for a GTEN 100 treatment protocol in epilepsy.
Don Tucker, PhD, Chairman and CEO of EGI, said:
“We are highly encouraged by the support we have received from these key international epilepsy centres. We believe our technology will have an important place in the suppression of seizures in patients who do not respond to drug treatments and that this represents an important first step in bringing GTEN 100 to market. We plan to investigate the use of our neuromodulation technology in a number of other important indications, such as depression, building on the results of this first feasibility trial.”
For more information contact:
EGI
UK: Christine Soden, CFO
+44 (0) 7710 484199
Peel Hunt LLP (NOMAD and Broker)
+44 (0) 20 7418 8900
James Steel, Clare Terlouw
FTI Consulting (PR Advisors)
+44 (0) 20 3727 1000
Simon Conway, Mo Noonan
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
Help employers find you! Check out all the jobs and post your resume.