LONDON (Alliance News) - Electrical Geodesics Inc Monday said it had received an investigational device exemption from the US Food and Drug Administration that will allow it to undertake clinical studies that will seek to demonstrate the safety and feasibility of its GTEN neuromodulation device as a treatment for managing epilepsy.
An investigational device exemption allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support further submissions. All clinical evaluations of investigational devices, unless exempt, must have an approved investigational device exemption before the study is initiated.
Electrical Geodesics' Geodesic Transcranial Electrical Neuromodulation device will use the company's head modelling technology 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 device's 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 company is planning that the study will be conducted at two centres: Harborview Hospital at Washington University and the company's own facility in Eugene under the direction of an external neurologist. It will seek to evaluate and treat around 20 patients, and the results will guide the company's potential pivotal studies and move towards clinical approval.
Electrical Geodesics shares were down 0.4% at 138.00 pence Monday morning.
By Steve McGrath; stevemcgrath@alliancenews.com; @stevemcgrath1
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