Cyberkinetics Neurotechnology Systems, Inc. Files To Market Andara(TM) OFS(TM) Therapy For Acute Spinal Cord Injury Under Humanitarian Device Exemption

FOXBOROUGH, Mass.--(BUSINESS WIRE)--Cyberkinetics Neurotechnology Systems, Inc. (OTCBB: CYKN; “Company;” “Cyberkinetics”), announced that it submitted a Humanitarian Device Exemption (HDE) to the Food and Drug Administration (FDA) to obtain market clearance for the implantable Andara™ OFS™ (Oscillating Field Stimulator) System, a nerve growth stimulator. If approved, Cyberkinetics’ Andara™ OFS™ System would be the first commercially available neurotechnology device designed to partially restore sensation and motor function in acute spinal cord injuries by stimulating nerve repair.
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