26 February 2016
Polyganics Receives Chinese Food and Drug Administration (CFDA) Approval for NEUROLAC®
Beijing, China, 26 February 2016 – Polyganics today announced it has received Chinese FDA (CFDA) clearance for NEUROLAC®, a unique synthetic and resorbable nerve conduit designed to support regeneration of peripheral nerve discontinuities up to 20 mm in patients who have sustained a complete division of a nerve.
Rudy Mareel, CEO a.i.: “NEUROLAC® offers a valuable treatment option for surgeons dealing with peripheral nerve discontinuities and for Polyganics this approval to market NEUROLAC® in China is an important step in further expanding the global distribution of our products.”
The clearance was realized in close collaboration with PolyCare Technology (Beijing) Co., Ltd (www.polycare.com.cn), the exclusive distribution partner of Polyganics’ PNR portfolio for China.
Davy Zhu, Chief Executive Officer of Polycare: “With NEUROLAC® Polycare can contribute our surgeons with a high quality peripheral nerve repair product that enhances the patient’s functional nerve recovery.”
For more information on NEUROLAC®, please use this link
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, and approval from CFDA and from other international authorities.