Anunciainc

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City: Scottsdale

State: Arizona

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Country: United States

Anuncia Medical is an early-stage commercial, patient-centric MedTech company with the US cleared and EU-approved, clinically validated, noninvasive, therapeutic device solutions and a robust product pipeline to disrupt the Cerebrospinal Fluid (CSF) Management space. We uniquely address the largest unmet need in CSF Management; the high rate of ventriculoperitoneal (VP) shunt occlusion. VP shunts fail at a rate of 50% within 2 years and 80% within 5 years, contributing to repeat revision brain surgeries (each costing upwards of $40,000). Conceptualized in 2014 in collaboration with Boston Children’s Hospital and spun out of Alcyone Therapeutics in 2018, Anuncia’s patented portfolio of technologies provide peace-of-mind through innovation to improve daily quality of life for the millions of underserved patients with hydrocephalus and other CSF disorders and their families, who suffer from the clinical, economic, and emotional burden of repeat revision brain surgery due to VP shunt occlusions. Anuncia’s core platform has an elegant mechanism of action using a simple finger depression of a soft silicone dome located under the patient’s scalp to produce a noninvasive, retrograde flush of the patient’s own CSF to restore flow through an occluded catheter and prevent emergency surgery. ReFlow’s initial clinical evidence of flow restoration and reduction of symptoms via acute intervention flushing with follow-up up to 3 years, led neurosurgeons to evaluate ReFlow for prophylactic occlusion prevention in their high-risk patients. Ground-breaking clinical data, now out up to 2 years with 100% success, suggest ReFlow is safe for at-home, prophylactic flushing by patients or caregivers to extend shunt life and eliminate revision brain surgery. Supported by these encouraging results, the U.S. Food and Drug Administration (FDA) granted ReFlow Breakthrough Device status in 2021, making it eligible for regulatory and reimbursement advantages. With existing profitable reimbursement, Anuncia plans to launch its next-generation ReFlow Mini product line in Q2 2022 and continue clinical studies to support market adoption and premium reimbursement. With Breakthrough status and strong health economic advantages to improve hospital quality metrics and support New Technology Add-on Payment (NTAP) for rapid market adoption and premium pricing; Anuncia is positioned to be the leader in CSF management and help patients live fuller lives. ReFlow’s unique ability to improve patient access to noninvasive lifesaving therapy at home or in the clinic and to improve clinical outcomes and quality of life, and reduce healthcare costs, earned it an Honorable Mention in the Fast Company 2021 World-Changing Ideas Awards and landed it on MDDI’s The Ultimate List of Private Companies to Watch.

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