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.
This special FDA designation will allow Cyberkinetics to file a Humanitarian Device Exemption (HDE) application with the FDA to use Cyberkinetics' Andara(TM) OFS Device to treat patients with acute, or recent, spinal cord injuries. Cyberkinetics expects to file the HDE application later this year.
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