The ReFlow™ Mini Flusher will Benefit the Lives of Patients in the US and Abroad where Access to Ongoing Advanced Clinical Care can be Limited
SCOTTSDALE, Ariz., July 26, 2023 /PRNewswire/ — Anuncia Medical Inc. (“Anuncia” or the “Company”), a Company specializing in advancing innovations for implantable and external cerebrospinal fluid (CSF) management systems and neurocritical care, is pleased to announce the successful U.S. commercial launch of the ReFlow™ Mini Flusher device. Neurosurgeons in the US and soon internationally will now have a new option to reduce the impact of hydrocephalus by providing better access to potentially life-saving therapy for the 30 million patients worldwide suffering from this neurological disorder. Hydrocephalus is a chronic neurological condition in which excess CSF accumulates in the brain, often causing severe symptoms, frequent hospitalizations, and ongoing health concerns, and may be fatal if left untreated.
Data recently published in the Journal of Pediatric Neurosurgery on the first generation ReFlow device suggests that ReFlow prophylactic use, designated as a US FDA Breakthrough Device indication Anuncia intends to further explore in future clinical studies, may reduce the high rate of shunt malfunctions due to catheter occlusions and associated repeat revision brain surgeries. The just launched second-generation ReFlow Mini Flusher is FDA-cleared for use in patients living with hydrocephalus or similar conditions. Its reduced size and profile are designed to better support a broader hydrocephalus patient population, from infants to older adults. Used in line with any shunt system brand, the patented ReFlow Mini Flusher is uniquely designed to flush the patient’s CSF back into the ventricular catheter to maintain, restore or increase hydrocephalus shunt flow with just a simple push of the flusher’s soft dome located beneath the patient’s scalp. Noninvasive flushing with the ReFlow Mini Flusher does not interfere with shunt flow regulation and can be performed in-clinic by trained clinical staff, or anywhere by a trained patient/caregiver, as directed by the treating neurosurgeon.
Since the ReFlow Mini became available earlier this month, multiple leading centers across the country have successfully implanted the technology. Patients are already using the ReFlow Mini to manage their chronic hydrocephalus. Beyond the U.S., Anuncia actively seeks opportunities to assist neurosurgeons in regions where treating the condition remains challenging. Most notably, international news organizations are currently covering a public health crisis in Uganda, highlighting how a bacterial outbreak has led to a new surge in hydrocephalus cases. The Company is currently seeking strategic partners who share the belief that the ReFlow Mini could improve the lives of undermanaged patients.