FOXBOROUGH, Mass.--(BUSINESS WIRE)--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; “Company;” “Cyberkinetics”), announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) requesting additional analyses and data regarding its Humanitarian Device Exemption (HDE) marketing application for the Andara™ OFS™ (Oscillating Field Stimulator) System, a nerve growth stimulator designed as a treatment for acute spinal cord injuries. Based on the FDA’s request for additional data and analyses, the Company now expects that approval of its Andara™ OFS™ System for the treatment of acute spinal cord injury may be delayed until at least the first half of 2008.
