Relieving Pressure on the Brain
Cerebrospinal fluid (CSF) normally flows through the cavities (ventricles) of our brains and bathes our brain and spinal column. Hydrocephalus is a condition caused by a buildup of this fluid deep within the brain. The excess fluid puts pressure on the brain. This pressure can damage brain tissues and cause a range of brain function problems. Hydrocephalus can happen at any age, but it occurs more frequently among infants and adults 60 and over.
When patients are living with hydrocephalus, a surgeon may determine that the best treatment is to insert a small tube or shunt into the brain to drain the fluid and relieve the pressure. If it gets clogged, the procedure may need to be repeated. Data shows that these shunts fail at a rate of up to 50% within 2 years and 80% within 5 years, contributing to repeat revision brain surgeries.
Anuncia Medical is developing products to address this clogging challenge and improve the care and quality of life for people with hydrocephalus.
Collaborations with Boston Children’s Hospital and Alcyone Therapeutics supported the development of Anuncia’s patented portfolio of technologies designed to improve the daily quality of life for millions of people living with hydrocephalus and other CSF disorders by aiming to better the standard of care and potentially reduce the burden of repeat revision brain surgery.
Anuncia’s ReFlow™ device is implanted by the surgeon as part of a shunt system and offers a noninvasive way to attempt to restore or increase the flow in a non-flowing shunt. The system includes a soft silicone dome located under the patient’s scalp. Should the drainage device become restricted or clogged, softly pressing on the dome creates a flush that can restore the flow and prevent emergency surgery.
ReFlow’s initial clinical evidence of flow restoration and reduction of symptoms via acute intervention flushing, led neurosurgeons to evaluate ReFlow for prophylactic occlusion prevention in their high-risk patients. Ground-breaking clinical data, now spanning 2-3 years, suggests that ReFlow may be safe for at-home, prophylactic flushing by patients or caregivers to potentially extend shunt life and reduce revision brain surgery.
Supported by these encouraging results, the U.S. Food and Drug Administration (FDA) granted ReFlow with Breakthrough Device status in 2021, making it eligible for a shorter regulatory pathway and reimbursement.
Anuncia plans to launch its next-generation ReFlow Mini product line in the near future and continue clinical studies and trials in hydrocephalus. The company is also developing new therapeutic and monitoring devices for neurocritical care, Alzheimer’s Disease care, and CSF drug delivery.
In the past 18 months, Anuncia Medical has hired 4 full-time executive team members, 2 full-time engineers from ASU, 3 more employees who relocated to Arizona, and 3 student interns.
“Patients and their care teams call on our health innovators to address areas of care where new and better solutions are needed,” said Joan Koerber-Walker, President & CEO of AZBio. “Anuncia Medical is being honored as a 2022 Fast Lane Company for the progress they are making in answering the call from people with hydrocephalus and growing their team to deliver on solutions.”