IDE Clearance from FDA to Commence Feasibility Clinical Trials for GTEN in Epilepsy

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2 March 2015 – Electrical Geodesics, Inc. announces receipt from the US Food and Drug Administration (FDA) of an Investigational Device Exemption (IDE) which will allow the Company to undertake clinical studies seeking to demonstrate the safety and feasibility of its GTEN neuromodulation device as a treatment for managing epilepsy.

An IDE allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Notification or 510(k) submission. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated.

GTEN, the Geodesic Transcranial Electrical Neuromodulation device is EGI’s latest development of its world-leading GES 400 dense array EEG platform. GTEN will use EGI’s advanced head modeling technologies to understand the areas of the brain where treatment should be focused. The device and software will then deliver small amounts of highly targeted electrical current through a changing pattern of the devices 256 electrodes in order to direct treatment to the focal area and spare treatment to non-target areas. During and after treatment the same device and electrodes can record brain activity to monitor the safety and effect of the product.

The initial study will be in epilepsy, a life-threatening and debilitating condition where more than 25% of patients are drug refractory or resistant, where seizures result from electrical discharges which frequently derive from a single source of abnormal or damaged brain tissue. In time, seizures can move to multiple sources. Whilst the frequency and severity of seizures varies, epilepsy is characterized by more frequent small electrical discharges or inter-ictal spikes, the incidence of which is used by clinicians to assess and treat patients. Most brain neuromodulation devices are contra-indicated in epilepsy, with the concern that seizures might be induced rather than modulated or reduced, but research evidence has shown that well-directed magnetic or electrical stimulation can reduced the incidence of inter-ictal spikes.1 It is this research and concern for safety that led EGI to propose to the FDA a feasibility and safety study with the primary endpoint of the temporary reduction in the frequency of inter-ictal spikes and to request an IDE.

It is planned that the study will be conducted at two centres, Harborview Hospital at Washington University and at EGI’s own facility in Eugene under the direction of an external neurologist and will seek to evaluate and treat around 20 patients. Upon completion of the study and guided by its results, the Company will investigate routes to conduct pivotal studies and move towards clinical approval.

Don Tucker, CEO of EGI, commented: “For some years we have had a strong belief in the potential of dense array electrical neuromodulation as a treatment in intractable neurological conditions and see it as a natural extension of our expertise in the monitoring and imaging of brain activity. Our current GES 400 platform was designed to allow the flexibility to both measure and deliver targeted electrical currents and we are pleased the inherent safety offered by our ability to monitor the effect of treatment as it is delivered has given the FDA confidence to allow us to study GTEN in epilepsy. The neuromodulation market is booming and we are hugely excited about the potential for GTEN initially as a driver of research sales and later as an important clinical tool.”

1. Fregni, F., et al. (2006). "A randomized clinical trial of repetitive transcranialmagnetic stimulation in patients with refractory epilepsy." Ann. Neurol. 60(4): 447-455. Sun, W., et al. (2011). "Low-frequency repetitive transcranial magnetic stimulation for the treatment of refractory partial epilepsy." Clin. EEG Neurosci. 42(1): 40-44.

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