Polyganics Neurolac(R) Nerve Guide Receives FDA Clearance

Oct 20, 2003, 01:00 ET from Polyganics B.V.

    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.