GRONINGEN, Netherlands, Oct. 20 /PRNewswire/ -- Polyganics B.V. announced today that it received FDA 510(k) clearance for Neurolac, the first bioresorbable synthetic transparent nerve guide. "The most severe form of peripheral nerve damage is a total lesion and consequential loss of nerve function. Although peripheral nerves can regenerate spontaneously their function is not automatically restored. Currently the standard surgical treatment for repair of peripheral nerve lesions is end-to-end suturing or if the gap is too large the interposition of a nerve transplant from another part of the patients body. Both techniques are time-consuming, give rise to complications and do not lead to optimal nerve function recovery," said Jan-Bart Hak (Manager Clinical and Regulatory Affairs) of Polyganics B.V. "Our transparent peripheral nerve guide, an FDA class II device, is a bioresorbable tube that is sutured to both ends of the transected nerve and guides the outgrowing nerve in a protective environment, preventing neuroma formation. After the nerve function has been restored, the nerve guide is gradually and completely resorbed by the body. Neurolac is successfully applied clinically in Europe." Neurolac is the first transparent nerve guide available to reconstructive surgeons the US. Its transparency is considered a tremendous advantage as it allows easy and rapid closure of the nerve gap. Moreover, because of its synthetic character Polyganics' nerve guide offers maximum safety to the patient versus some animal derived materials and is expected to be widely accepted by hospitals and individual surgeons. "We sell directly to end-users," said Jan Smit (Managing Director). "Several companies have shown keen interest to market the product in the US and in other parts of the world, which is understandable considering a market global potential of over $50 million per year. We expect to announce commercial alliances in the near future." Polyganics B.V., a privately held biomedical company based in The Netherlands, markets, develops and manufactures synthetic biodegradable break-through solutions to medical needs. Polyganics' products strongly reduce the number of medical interventions and improve patient comfort while lowering health care costs. Neurolac is one of a series based on Polyganics' proprietary synthetic bioresorbable materials. Polyganics B.V. has its headquarters, manufacturing and research facilities at L.J. Zielstraweg 1, 9713 GX Groningen, The Netherlands. Please visit Polyganics' website: www.polyganics.com
SOURCE Polyganics B.V.