What is Neurapheresis?
Neurapheresis is Pharaoh Neuro's investigational closed loop CSF management platform, designed for the accelerated removal of blood and blood-breakdown products from the cerebrospinal fluid of patients following aneurysmal subarachnoid hemorrhage.
ANNOUNCEMENT BREAKTHROUGH DEVICE DESIGNATION
Pharaoh Neuro, Inc., a medical device company developing innovative technologies for neurocritical care, today announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation to its Neurapheresis® Cerebrospinal Fluid (CSF) Management System for the accelerated removal of blood and blood-breakdown products from the CSF of patients following aneurysmal subarachnoid hemorrhage (aSAH).
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Why CSF Matters
Cerebrospinal fluid is the brain's natural protective environment. It cushions the brain and spinal cord, helps maintain intracranial pressure, clears metabolic waste, and circulates essential nutrients.
After aneurysmal subarachnoid hemorrhage, blood and blood-breakdown products can enter that space and alter the environment around the brain.
Pharaoh Neuro's work is built around a simple clinical idea: if that environment matters, managing it more actively may matter too.
About Neurapheresis®
Neurapheresis is a closed loop CSF management platform designed to circulate and filter a patient's own (autologous) CSF without introducing replacement fluids. The program is built on evidence from Pharaoh's PILLAR and PILLAR-XT clinical studies.
Neurapheresis is an investigational device and has not received FDA approval or clearance.
Scientific Sources
Peer-reviewed publications and guideline context supporting the science behind active CSF management.
Important Safety and Regulatory Information
Neurapheresis is an investigational device limited to investigational use under an Investigational Device Exemption (IDE). It has not been cleared or approved by the U.S. Food and Drug Administration. Breakthrough Device Designation is not FDA clearance or approval.