FDA 授予 Pharaoh Neuro 的 Neurapheresis™ 脑脊液管理系统突破性器械认定

Designation recognizes the potential of Neurapheresis to offer advantages over existing treatment options following aneurysmal subarachnoid hemorrhage (aSAH)

, /PRNewswire/ -- Pharaoh Neuro, Inc., (https://pharaohneuro.com), a medical device company developing innovative solutions for neurocritical care, announced that the U.S. Food and Drug Administration has granted Breakthrough Device Designation (BDD) to its Neurapheresis™ Cerebrospinal Fluid (CSF) Management System for the accelerated removal of blood and blood- breakdown products from the CSF of patients following aSAH.

Pharaoh Neuro is also participating in the Total Product Lifecycle Advisory Program (TAP) Pilot. BDD and TAP provide the opportunity for more frequent, interactive engagement with FDA and streamlined review as the company advances the Neurapheresis System toward potential marketing authorization.

"The Breakthrough Device Designation is a significant milestone for Pharaoh Neuro," said Amaza Reitmeier, Chief Executive Officer. "It validates our belief that Neurapheresis offers significant advantages over existing approved or cleared alternatives. We look forward to working closely with the agency to bring this technology to patients as quickly as possible."

Addressing an Unmet Need in Aneurysmal Subarachnoid Hemorrhage

Aneurysmal subarachnoid hemorrhage is a form of hemorrhagic stroke affecting approximately 30,000 people in the United States each year¹. It strikes a relatively young population², and the consequences are lasting: roughly one in four survivors does not return to functional independence, and an estimated two-thirds are unable to return to their previous employment³.

After the aneurysm is secured, current standard of care relies on passive, open-loop drainage systems to manage CSF pressure while blood gradually clears from the CSF. No cleared or approved device is currently available to actively remove blood and blood-breakdown products from the CSF.

A Closed-Loop Approach to CSF Management

The Neurapheresis System represents a novel approach: a closed-loop, external, automated CSF management platform designed to aspirate, filter and return a patient's CSF, removing blood and blood-breakdown products without introducing replacement fluids. The safety and feasibility of the investigational system were evaluated in the PILLAR-XT⁴ clinical trial, published in Neurocritical Care.

"Significant clinical challenges remain in caring for patients following aSAH," said Spiros L. Blackburn, M.D., 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."

"Breakthrough Device Designation is an important recognition of the clinical need we set out to address," said Nandan Lad, M.D., Ph.D., Chief Medical Officer of Pharaoh Neuro and inventor of the Neurapheresis System. "We remain committed to a rigorous, evidence-based path forward with FDA as we work to bring an active approach to CSF management to patients and clinicians."

References

1 Xia C, Hoffman H, Anikpezie N, Philip K, Wee C, Choudhry R, Albright KC, Masoud H, Beutler T, Schmidt E, Gould G, Patel SD, Akano EO, Morris N, Chaturvedi S, Aneni E, Lamikanra O, Chin L, Latorre JG, Otite FO. Trends in the Incidence of Spontaneous Subarachnoid Hemorrhages in the United States, 2007-2017. Neurology. 2023 Jan 10;100(2):e123-e132.

2 Sabra, A., Philip, K., Levin-Carrion, Y., Ha, C. J., Sahoo, A., Huynh, T., Landzberg, D., Singla, A., Liu, J. K., Atchaneeyasakuul, K., Khandelwal, P., & Otite, F. O. (2026). Medical Complications After Aneurysmal Subarachnoid Hemorrhage: Analysis of Trends in US Admissions from 2006 to 2022. Neurocritical Care, 44(3), 1025-1035.

3 Stokum JA, Cannarsa GJ, Wessell AP, Shea P, Wenger N, Simard JM. When the Blood Hits Your Brain: The Neurotoxicity of Extravasated Blood. Int J Mol Sci. 2021 May 12;22(10):5132..

4 Blackburn SL, Babi MA, Grande AW, Choudhri OA, Hauck EF, Kellner CP, Giordano MC, Lad SP, McCabe AR. Prospective Trial of Cerebrospinal Fluid Filtration After Aneurysmal Subarachnoid Hemorrhage via Lumbar Catheter Extension (PILLAR-XT). Neurocrit Care. 2025;43:934–946

About Pharaoh Neuro

Pharaoh Neuro, Inc. is a Minneapolis-based medical device company developing novel technologies that give physicians and the patients they treat improved options during the most critical moments in neurointerventional care. The company combines decades of medical device and neurosurgical expertise with an aspiration to protect the brain.
For more information, visit https://pharaohneuro.com

About the FDA Breakthrough Devices Program

The Breakthrough Devices Program is a voluntary FDA program for medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. To be eligible, a device must also meet at least one additional criterion: it represents a breakthrough technology, no approved or cleared alternatives exist, it offers significant advantages over existing approved or cleared alternatives, or its availability is in the best interest of patients. Designation is not an approval or clearance and does not authorize commercial sale in the U.S.

Important Safety and Regulatory Information

The Neurapheresis System 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 (FDA). BDD does not change the investigational status of the device.

Media Contact:

[email protected]
(612) 900-2099

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. 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.

SOURCE Pharaoh Neuro