26 January 2016
Polyganics Receives FDA 510(k) Clearance for Nerve Capping Device NEUROCAP
Groningen, The Netherlands, 26 January 2016 – Polyganics, a privately held medical technology company focused on the commercialization of proprietary products and technologies for peripheral nerve repair, neurosurgery, general surgery, as well as ear, nose & throat surgery, today announced it has received FDA 510(k) clearance for NEUROCAP, an innovative device designed to reduce painful neuroma formation and thereby facilitate tissue repair and regeneration.
Rudy Mareel, CEO a.i. of Polyganics said, “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 US FDA 510(k) clearance for NEUROCAP is another major milestone for Polyganics.”
NEUROCAP is available in the USA through MicroAire Surgical Instruments LLC (www.microaire.com), the exclusive distribution partner of Polyganics’ PNR portfolio for the USA, Canada and Puerto Rico.
Polyganics is a medical technology company with multiple versatile polymer platforms. The Company develops, manufactures and commercializes innovative bioresorbable medical devices that facilitate tissue repair and regeneration.
Polyganics’ portfolio includes products developed in-house and in collaboration with leading medical technology companies and academic centers of excellence. In the Peripheral Nerve Repair (PNR) and neurosurgery field, the portfolio includes three marketed products: VIVOSORB® for minimizing unwanted tissue adhesions after surgery; NEUROLAC® for supporting PNR following hand surgery; and NEUROCAP for the management of symptomatic neuromas. Products in development include a sealant for the dural membrane, for use post brain surgery.
In 2014, the Company sold its Ear, Nose & Throat (ENT) surgery business unit (the NASOPORE® product family including HEMOPORE®, SINUPORE® and OTOPORE®) to US Company Stryker, one of the world’s leading medical technology companies. NASOPORE®, a reliable, easy-to-use, nasal wound care dressing made of biodegradable foam, has been used in over 2.5m procedures globally.
Polyganics has a supportive shareholder base, including the investment agency of the Northern Netherlands (NOM), and the University of Groningen. The Company has a research partnership with the non-profit organization the Brain Technology Institute, an international group of neurosurgeons.
Polyganics is profitable and privately held. The Company is based in Groningen, The Netherlands, a center of biomedical engineering excellence, in an ISO 13485-certified manufacturing facility. The Company’s polymer platform technologies are protected by a broad portfolio of patents and its products have received clearance from FDA, CE-approval, approval from CFDA and from other international authorities.