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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.
The KARL STORZ Fetoscopy Instrument Sets will be marketed under the FDA's Humanitarian Use Device (HUD) program, which encourages development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the U.
Cyberkinetics is seeking to obtain Humanitarian Use Device (HUD) Designation from the FDA to support the filing of a Humanitarian Device Exemption (HDE) in mid 2006.
With the application for designation as a Humanitarian Use Device already submitted, we look forward to bringing this important therapeutic platform forward toward market launch.

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