Polyganics said today it won FDA 510(k) clearance for its Neurocap device, designed to reduce neuroma formation and facilitate tissue repair.
Neuromas, also known as pinched nerves or nerve tumors, are benign growths of nerve tissue that can cause pain, burning sensation, tingling or numbness, according to the company.
“Neuroma-induced neuropathic pain and morbidity can seriously affect the quality of a patient’s daily life. Neurocap, a transparent tubular device with a sealed end, is the first and only synthetic nerve capping device cleared for the management of symptomatic neuromas. 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 U.S. FDA 510(k) clearance for Neurocap is another major milestone for Polyganics,” CEO Rudy Mareel said in prepared remarks.
Last week, Polyganics said it signed an exclusive distribution deal with strategic partner MicroAire Surgical Instruments that will put it in charge of distributing Polyganics peripheral nerve repair portfolio in the U.S., Canada and Puerto Rico.