Polyganics has received FDA 510(k) clearance for Neurocap, a device designed to reduce neuroma formation and facilitate tissue repair and regeneration
Neurocap is a transparent tubular device with a sealed end, is the first synthetic nerve capping device cleared for the management of symptomatic neuromas.
Rudy Mareel, CEO of Polyganics, said: “Neuroma-induced neuropathic pain and morbidity can seriously affect the quality of a patient’s daily life.
“Current approaches are based on surgical removal of the neuroma and surrounding scar tissue, then placing the nerve stump in tissue subjected to minimal mechanical stimulation. However, these approaches have in many cases unsatisfactory outcomes.
“With our bioresorbable medical device Neurocap we offer orthopedic and hand surgeons a valuable new tool that contributes to the clinical management of neuromas and that can improve the daily life of patients.
“Receiving US FDA 510(k) clearance for NEUROCAP is another major milestone for Polyganics.”
Polygeanics is a privately held medical technology company focused on the commercialisation of proprietary products and technologies for peripheral nerve repair, neurosurgery, general surgery, as well as ear, nose and throat surgery.