DynaMed Systems Obtains FDA Approval to Study Its Traxon® Spinal Cord Repair Stimulation System in Acute Spinal Cord Injured (SCI) Patients

NEW YORK--(BUSINESS WIRE)--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).

About The TRAXON® Spinal Cord Stimulation System

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.

About DynaMed Systems

DynaMed Systems, LLC is the developer and manufacturer of medical devices that promote the regeneration and recovery of the central nervous system (CNS), the peripheral nervous system (PNS) and other soft tissues such as tendons, ligaments and skin.

DynaMed has focused its research and development on surgically implanted and topically applied devices which are at various stages of development. Each device uses low-strength electric fields that are applied in a specific orientation, strength and duration to promote the recovery and healing of damaged nerves and soft tissues.

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