Anuncia Medical

Anuncia Medical is a private, commercial-stage medical device company developing innovative solutions for hydrocephalus and CSF management. The company's flagship technology, the ReFlow® System, has received FDA clearance and Breakthrough Device Designation for its EVD Flusher variant, offering a noninvasive method to maintain shunt patency. Founded in 2016 and based in Scottsdale, Arizona, Anuncia targets a significant clinical problem where a large percentage of shunts fail within two years due to occlusion. The company is positioned in the urology and neurosurgery sectors with a clear focus on improving patient outcomes and reducing surgical burden.

The ReFlow® platform features implantable, noninvasive flushing devices designed to clear occlusions in cerebrospinal fluid (CSF) shunt catheters and external ventricular drains (EVDs). The core technology involves a patient- or clinician-activated mechanism that sends a controlled fluid pulse to dislodge blockages and restore flow, including a proprietary ventricular catheter with a backup relief membrane.

Anuncia operates in the hydrocephalus shunt market, long dominated by large players like Medtronic and Integra LifeSciences. Its primary competitive advantage is the unique, noninvasive mechanism of the ReFlow system, for which there is no direct equivalent currently on the market. Competition comes from alternative technologies (e.g., antibiotic-impregnated catheters to reduce infection) and the entrenched preference for traditional shunt systems without an integrated flushing mechanism.