Cyberkinetics Receives FDA Response Letter On Andara OFS

Looking for potential FDA approval in 2008 based on trials and studies...a new way to stimulate nerve repair and restore sensory and motor function...system is removed after 14 weeks of therapy..great technology to restore movements to those with nerve damage and lost of motion. that are months to years old..BD

Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; "Company;" "Cyberkinetics"), announced 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.

"The FDA has identified additional information related to our clinical and engineering data that we must provide prior to completion of their review of the Andara™ OFS™ HDE," stated Timothy R. Surgenor, Cyberkinetics' President and Chief Executive Officer. "We look forward to working with the FDA over the coming weeks to fully understand their requirements. We believe that we can provide the information that the FDA has requested in an additional amendment to our HDE application in early 2008.

In the future, the BrainGate System could be used by those individuals whose injuries are less severe. Next generation products may be able to provide an individual with the ability to control devices that allow breathing, bladder and bowel movements.