Anuncia Medical has secured Breakthrough Device Designation from the U.S. Food and Drug Administration for its innovative ReFlow External Ventricular Drain (EVD), a device designed to address the critical challenges of brain swelling and elevated intracranial pressure management.
The ReFlow EVD represents a significant advancement in neurocritical care, featuring a first-of-its-kind noninvasive, manual flushing mechanism that helps restore and maintain cerebrospinal fluid (CSF) flow. This innovation addresses a substantial clinical need, as more than 100,000 EVD procedures are performed annually in the United States to relieve elevated intracranial pressure in patients with traumatic brain injuries, strokes, and other neurological conditions.
Transforming Neurocritical Care Workflows
Unlike traditional EVD systems that require neurosurgeon intervention when blockages occur, the ReFlow EVD enables nurses to perform noninvasive flushing as part of routine patient care. This streamlined approach has the potential to prevent prolonged ICU stays, reduce the need for additional neurosurgical procedures, and eliminate costly EVD replacements.
"This regulatory milestone highlights the broader impact of our ReFlow innovation beyond hydrocephalus management," said Elsa Chi Abruzzo, CEO and President of Anuncia Medical. "We continue to hear from neurosurgeons, nurses, patients, and families that ReFlow's simple, seconds-long manual flush helps prevent blockages—improving outcomes and providing peace of mind."
The ReFlow EVD joins Anuncia's growing portfolio of CSF management solutions, which includes the ReFlow System Mini and the ReFlow Mini Flusher, both of which have demonstrated success in hydrocephalus care. The company's expanded product line reinforces its commitment to advancing both acute and long-term CSF management.
Advancing Hydrocephalus Research and Treatment
Beyond its breakthrough device designation, Anuncia has received a grant from the Flinn Foundation's Bioscience Entrepreneurship Program to support post-FDA clearance studies of the ReFlow Mini Flusher. This research initiative, led by Dr. Jason Hauptman of Phoenix Children's Hospital and Dr. Anthony Avellino of HonorHealth Medical Group, aims to generate critical clinical evidence for hydrocephalus patients at high risk of shunt occlusion.
The study will focus particularly on patients affected by Coccidioidomycosis (Cocci) Meningitis, a serious complication of Valley Fever and a regional health concern in the southwestern United States.
"This grant allows us to generate the high-quality, prospective clinical data needed for broader commercial adoption, further cementing Arizona as a leader in neurosurgical excellence," said Dr. Avellino. "By partnering with Dr. Jason Hauptman, Chief of Neurosurgery at Phoenix Children's, we are advancing hydrocephalus care while showcasing Arizona's world-class institutions as a national model."
Global Impact and Partnerships
Recognizing the global disparities in hydrocephalus treatment, Anuncia has formed a strategic partnership with NeuroKids.org to expand access to care in underserved regions, particularly in Sub-Saharan Africa where bacterial meningitis often leads to post-infectious hydrocephalus.
The collaboration aims to bring Anuncia's technology to vulnerable populations in Zambia, Kenya, and Uganda, where access to neurosurgical care remains limited. An estimated 30 million people worldwide are affected by hydrocephalus, with many lacking access to effective treatment options.
"Anuncia Medical's revolutionary ReFlow device has the power to provide peace of mind to parents and patients living with hydrocephalus," said Derek Johnson, Chief Executive Officer of NeuroKids.org. "NeuroKids is proud to partner with Anuncia Medical to bring this technology to some of the most vulnerable populations living in Africa."
Future Directions
Early data from the U.S. commercial rollout of Anuncia's technology suggests that ReFlow may help prevent catheter blockages, potentially reducing emergency surgeries—a benefit that is especially critical in areas where neurosurgical care is limited.
The company is also developing remote monitoring systems to improve real-time patient management and long-term outcomes, positioning itself at the forefront of neurocritical care innovation. Through continued research and strategic partnerships, Anuncia aims to build a strong body of clinical evidence to support additional regulatory claims and expanded reimbursement, driving broader adoption of its technologies as the standard of care for hydrocephalus treatment and neurocritical care.
