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We have recently filed a Humanitarian Device Exemption to market the Andara[TM] OFS[TM] Therapy in the United States and have also begun the regulatory process to support introduction of the device in the European markets in 2008. In September 2006, we received Humanitarian Use Device (HUD) Designation for our Andara[TM] OFS[TM] System as a treatment for acute spinal cord injury and, in February 2007, submitted a Humanitarian Device Exemption (HDE) to the Food and Drug Administration (FDA) to obtain market clearance. OTCBB: CYKN; "Company;" "Cyberkinetics"), announced that it submitted a Humanitarian Device Exemption ( |
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