FDA Grants Humanitarian Use Device Designation To Cyberkinetics Inc.' Andara(TM) OFS Device For Acute Spinal Cord Injuries; Designation Marks Critical Regulatory Step Toward Commercialization

FOXBOROUGH, Mass.--(BUSINESS WIRE)--Sept. 6, 2006--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; "Company;" "Cyberkinetics"), a neurotechnology company focused on neurostimulation and neural sensing, announced today that it has received notification from the Food and Drug Administration (FDA) that the Company's Andara(TM) Oscillating Field Stimulator (OFS) Device has been designated as a Humanitarian Use Device (HUD) for use immediately after (within 18 days) certain types of spinal cord injuries.