DynaMed Systems, LLC announced today that the U.S. Food and Drug Administration (FDA) has approved its investigational Device Exemption (IDE) Application to study the Traxon Spinal Cord Repair Stimulation System (TRAXON System) in acute spinal cord injured patients. The study is designed to assess the safety and effectiveness of the TRAXON System, a surgically implanted DC powered device, to improve motor function and other functional assessments in acute complete and incomplete SCI patients.

DynaMed Systems’ proprietary technology applies oriented and linear electrical fields to damaged nerve fibers. The clinical study will test the ability of the device to safely repair and improve function in those damaged nerves. The pilot study will include 24 patients between the ages of 18 and 73 who have suffered a recent spinal cord injury.

DynaMed Systems has been studying the TRAXON System in the United Kingdom since 2004 after receiving approval from the Medicines & Healthcare Products Regulatory Agency (MHRA).

DynaMed Systems’ patented technology applies oriented and linear electric fields to damaged nerve fibers. Under the influence of properly directed fields, cells grow in an organized fashion and migrate faster into damaged areas, resulting in more rapid and effective healing than would otherwise occur.