EUGENE, OREGON, US, 21 February 2014 – Electrical Geodesics, Inc. (“EGI” or the “Company”), a leading neurodiagnostic medical technology company, today announces receipt of notification from the US Food and Drug Administration (“FDA”) that its GES 400 EEG systems are now cleared for sale and use in clinical settings in the US market.
The Geodesic EEG System (“GES”) 400 platform adds three systems to EGI’s established product line and is aimed at filling the needs of a broad range of research and clinical customers, from entry level EEG through to the most advanced, dense array EEG (“dEEG”) imaging.
Based on EGI’s new ADAPT amplifier technology platform, the GES 400 platform’s state of the art hardware components allow faster flow of information, increased bandwidth and better networking. This speed and accuracy, alongside in-built computing capability, enables customers to operate multiple systems and undertake simultaneous review of brain activity from two or more people. Users can also access software updates and support remotely.
The CE Marked GES 400 systems have been available for research use since mid-2013 and for clinical use in Europe and other territories under that registration. This clearance from the FDA allows EGI to market these powerful monitoring devices to hospitals and clinics in the large US market. Additional regulatory clearances for clinical use of this platform will now be sought in other major markets such as Japan and China.
Receipt of this 510(k) clearance will enable EGI to rapidly launch its next generation operating software, Net Station 5.0, to existing and new customers.
Don Tucker, PhD, Chairman and CEO, commented: “We are delighted to receive 510(k) clearance for our GES 400 product and to be in a position to deliver this powerful technology to a wider market. With the further benefits we anticipate from the launch of Net Station 5.0, we believe the Company is well placed to increase revenues as we move through 2014.”
As previously announced the preliminary results for the year to 31 December 2013 will be released on 26 February 2014.
For more information contact:
EGI UK: Christine Soden, CFO +44 7710 484199
US: Ann Bunnenberg, COO +1 541 687 7962
Peel Hunt LLP (NOMAD and Broker) +44 (0) 20 7418 8900
James Steel, Clare Terlouw
FTI Consulting (PR Advisors) +44 (0) 20 7831 3113
Simon Conway, Mo Noonan
About EGI
Founded in 1992, EGI designs, develops and commercialises a range of non-invasive neurodiagnostic products used to monitor and interpret 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, capitalize 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).
In April 2013 EGI commenced trading on the London Stock Exchange AIM market under the symbol EGI.L. See www.egi.com for more information on the Company.
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