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.