FDA granted Pharaoh Neuro a Breakthrough Device Designation on October 28 for Neurapheresis, an external automated system that draws off a patient's cerebrospinal fluid, filters out blood and blood breakdown products, and returns the fluid with no replacement volume added. The designation covers accelerated removal of that blood after aneurysmal subarachnoid hemorrhage.
Safety and feasibility came from PILLAR-XT (NCT03607825), published in Neurocritical Care and led by Spiros Blackburn at UTHealth Houston. Pharaoh also holds a place in FDA's TAP pilot, which pairs more frequent agency contact with a shorter review path.
The company was founded in 2024 in Minnesota and closed a $20M Series A in February 2026, when it named Amaza Reitmeier chief executive. She ran neuromodulation at Medtronic as vice president and general manager. Neurapheresis is investigational and the designation does not authorize sale. A Breakthrough designation plus a TAP slot two years from founding is a strong regulatory position on $20M.