Anuncia Wins FDA Breakthrough Status for ReFlow® EVD

Anuncia Medical, Inc. ("Anuncia"), a pioneering company in CSF management and neurocritical care, has received Breakthrough Device Designation from the FDA for its ReFlow® EVD, an innovative solution for external ventricular drains (EVDs) used to manage brain swelling and elevated intracranial pressure. This milestone expands Anuncia's breakthrough portfolio, complementing the ReFlow® System Mini, a first-generation device with up to six years of clinical success, and the ReFlow® Mini Flusher, already transforming hydrocephalus care in its early U.S. rollout by enabling noninvasive, at-home CSF flow maintenance and reducing the need for costly revision surgeries. With ReFlow® EVD, Anuncia is advancing both acute and long-term CSF management, driving innovation, and expanding strategic opportunities in neurocritical care.

ReFlow® EVD: Advancing ICU Care and Patient Outcomes

EVDs are placed in more than 100,000 cases annually in the U.S. to relieve elevated intracranial pressure. The ReFlow® EVD is the first device of its kind to provide a noninvasive, manual flushing mechanism designed to restore and maintain cerebrospinal fluid (CSF) flow. By reducing the risk of occlusions, it helps prevent prolonged ICU stays, additional neurosurgical procedures, and costly EVD replacements. Unlike traditional flushing methods that require a neurosurgeon, ReFlow® EVD can be operated by nurses noninvasively during routine patient checks, seamlessly integrating into existing workflows to improve efficiency and reduce costs.

"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. Expanding our ReFlow portfolio reinforces our commitment to advancing neurocritical care and patient well-being."

Driving Innovation in Hydrocephalus Treatment

The Flinn Foundation has awarded Anuncia a meaningful grant through its Bioscience Entrepreneurship Program to support post-FDA clearance studies of the ReFlow® Mini Flusher. Led by Dr. Jason Hauptman (Phoenix Children's Hospital) and Dr. Anthony Avellino (HonorHealth Medical Group), the research aims to improve care and generate clinical evidence for hydrocephalus patients at high risk for shunt occlusion, including those affected by Coccidioidomycosis (Cocci) Meningitis, a serious complication of Valley Fever and regional health concern.

"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. Anthony M. Avellino, neurosurgeon and Chief Medical Officer of HonorHealth Medical Group – Specialty Care. "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."

While demand for CSF management technologies is high in developed nations, access to hydrocephalus care in low-resource settings remains a far greater challenge. In Sub-Saharan Africa, bacterial meningitis often leads to post-infectious hydrocephalus, yet many children lack access to life-saving treatment. To help bridge this gap, Anuncia has partnered with NeuroKids.org, founded by pioneering neurosurgeon Dr. Ben Warf of Boston Children's Hospital and led by CEO Derek Johnson, to expand hydrocephalus care in Zambia, Kenya, and Uganda.

"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."

The need for improved neurosurgical care extends beyond Africa, as patients in rural U.S. communities and underserved regions also face significant barriers. With an estimated 30 million people worldwide affected by hydrocephalus, access to effective treatment remains a critical challenge. Early data from its U.S. commercial rollout suggest ReFlow® may help prevent catheter blockages, potentially reducing emergency surgeries—an especially critical benefit where neurosurgical care is limited. Through partnerships and innovation, Anuncia is building a strong body of clinical evidence to support additional regulatory claims and expanded reimbursement, driving broader adoption and integration of ReFlow® into the standard of care for hydrocephalus treatment.