The US Food and Drug Administration (FDA) has granted breakthrough device designation to Pharaoh Neuro’s Neurapheresis, setting a course for the expedited development of its cerebrospinal fluid (CSF) management system.
Alongside its participation in the FDA’s total product lifecycle advisory program (TAP) pilot, the Minnesota-based company said the designation will give it the opportunity for more frequent engagement with the FDA and streamlined review protocols as it advances Neurapheresis towards a potential marketing authorisation.
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“The breakthrough device designation is a significant milestone for Pharaoh Neuro,” said the company’s CEO, Amaza Reitmeier.
“It validates our belief that Neurapheresis offers significant advantages over existing approved or cleared alternatives,” Reitmeier added.
Pharaoh’s Neurapheresis is a closed-loop CSF management platform designed to circulate and filter a patient’s own (autologous) CSF without introducing replacement fluids. It is currently under development with a view to advancing existing treatment options to patients following aneurysmal subarachnoid haemorrhage (aSAH).
The system’s safety and efficacy have previously been demonstrated in Minnetronix Neuro’s prospective PILLAR-XT trial (NCT03607825). The extracorporeal filtration of subarachnoid haemorrhage via spinal catheter extension study demonstrated the potential to significantly accelerate intracranial blood elimination and CSF red blood cell and protein reduction measures with Neurapheresis.
Research indicates that around 30,000 ventriculoperitoneal (VP) shunt procedures are performed in the US each year to address high CSF disorders such as pressure buildup (hydrocephalus), and to drain excess fluid following subarachnoid haemorrhage (SAH) or acute brain injuries.
“Significant clinical challenges remain in caring for patients following aSAH,” said Spiros Blackburn, Professor of Neurosurgery in the Vivian L. Smith Department of Neurosurgery at McGovern Medical School at UTHealth Houston and lead investigator of the PILLAR-XT study.
“In PILLAR-XT, we demonstrated that active filtration accelerates removal of blood and its breakdown products from CSF. These patients have very few new options, and breakthrough device designation is a promising step toward making neurapheresis available for them,” Blackburn continued.
Pharaoh was founded in 2024 and completed a Series A financing round in February 2026. Alongside the funding tranche, the company simultaneously appointed Reitmeier, who formerly served as vice president and general manager of neuromodulation at Medtronic, to the CEO role.
