TBD, 2026
FDA Grants Breakthrough Device Designation to Pharaoh Neuro’s Neurapheresis™ CSF Management System
February 18, 2026
Designation covers accelerated removal of blood and blood-breakdown products from cerebrospinal fluid following aneurysmal subarachnoid hemorrhage — a condition affecting 30,000 to 35,000 Americans a year for which no cleared or approved device exists
MINNEAPOLIS, Minn. — [DATE] — 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).
Aneurysmal subarachnoid hemorrhage is a form of hemorrhagic stroke affecting an estimated 30,000 to 35,000 people in the United States each year. It strikes a comparatively young population, and the consequences are lasting: roughly one in four survivors does not return to functional independence, and an estimated 67% never return to their previous employment.
“The Breakthrough Device Designation is a significant milestone for our company and validates our belief that Neurapheresis offers significant advantages over existing approved or cleared alternatives,” said Amaza Reitmeier, Chief Executive Officer of Pharaoh Neuro. “We are motivated to provide a better way to protect the brain for the over 30,000 people a year who suffer from aSAH. We look forward to working with the FDA to make the technology accessible as quickly as possible.”
The treatment of subarachnoid hemorrhage has not meaningfully changed. We secure the aneurysm, we manage the CSF pressure, and we wait. What we demonstrated in PILLAR-XT is that active filtration can remove blood and its breakdown products from the CSF. The Breakthrough Device Designation tells us the FDA recognizes the potential here. These are patients who have had very few new options, and I'm hopeful this is a step in the right direction for them.
MINNEAPOLIS, Minn. — [DATE] — 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).
Aneurysmal subarachnoid hemorrhage is a form of hemorrhagic stroke affecting an estimated 30,000 to 35,000 people in the United States each year. It strikes a comparatively young population, and the consequences are lasting: roughly one in four survivors does not return to functional independence, and an estimated 67% never return to their previous employment.
“The Breakthrough Device Designation is a significant milestone for our company and validates our belief that Neurapheresis offers significant advantages over existing approved or cleared alternatives,” said Amaza Reitmeier, Chief Executive Officer of Pharaoh Neuro. “We are motivated to provide a better way to protect the brain for the over 30,000 people a year who suffer from aSAH. We look forward to working with the FDA to make the technology accessible as quickly as possible.”
The treatment of subarachnoid hemorrhage has not meaningfully changed. We secure the aneurysm, we manage the CSF pressure, and we wait. What we demonstrated in PILLAR-XT is that active filtration can remove blood and its breakdown products from the CSF. The Breakthrough Device Designation tells us the FDA recognizes the potential here. These are patients who have had very few new options, and I'm hopeful this is a step in the right direction for them.
Spiros L. Blackburn, MD, Vivian L. Smith Department of Neurosurgery, McGovern Medical School at UTHealth Houston, and lead investigator of the PILLAR-XT study
About Pharaoh Neuro
Pharaoh Neuro, Inc. is a Minneapolis-based medical device company developing active solutions that protect the brain through a novel approach to cerebrospinal fluid (CSF) management. Its Neurapheresis™ CSF Management System is a closed-loop platform designed to actively manage a patient's own CSF. The company's portfolio also includes MindsEye™, the world's first expandable cranial access port. Pharaoh Neuro works with care teams to go beyond watchful waiting, bringing active CSF management and minimally invasive brain access to the critical moments in neuro care. The company combines decades of medical device and neurosurgical expertise with a mission to transform how clinicians treat the most critically ill neurological patients.
For more information, visit www.pharaohneuro.com/neurapheresis/ (What is NF page).
About the FDA Breakthrough Devices Program
The Breakthrough Devices Program is a voluntary FDA program for devices that may provide more effective treatment or diagnosis of life threatening or irreversibly debilitating conditions, and that offer significant advantages over existing approved or cleared alternatives. Designation is not an approval or clearance and does not authorize commercial sale in the United States.
Media Contact
info@pharaohneuro.com
(612) 582-4037
(612) 582-4037
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of
1995. These statements relate to, among other things, the anticipated development and regulatory pathway for the Neurapheresis
CSF Management System and MindsEye Expandable Port. Forward-looking statements are based on current expectations and
are subject to risks and uncertainties that could cause actual results to differ materially. These risks include, but are not limited
to, risks related to the development, regulatory review, and commercialization of medical devices. Pharaoh Neuro undertakes no
obligation to update forward-looking statements.
A medical device company developing innovative solutions for neurocritical care — advancing active CSF management after aneurysmal subarachnoid hemorrhage.
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