Polyganics Starts Clinical Trials With Its Transparent And Bioresorbable Peripheral Nerve Guide

Oct 03, 2002, 01:00 ET from Polyganics B.V.

    GRONINGEN, Netherlands, Oct. 3 /PRNewswire/ -- Polyganics B.V. has
 announced that the first patients with peripheral nerve injuries have been
 enrolled in the multi-centre clinical trials for its transparent and fully
 synthetic bioresorbable peripheral nerve guide.
     The trials are supervised by Prof. J.P.A. Nicolai, principal investigator
 and head of the Department of Plastic Surgery of the University Hospital in
 Groningen and by Prof. M.J.P.F. Ritt, head of the Department of Plastic
 Surgery of the VU University Hospital in Amsterdam. Co-investigators
 Prof. P.H. Robinson and M.J.O.E. Bertleff conducted the first implantations at
 the Groningen University Hospital. The clinical trials concentrate on
 restoring function following traumatic injury of the nerves controlling hand
 functionality. Damage to these nerves affects the performance of many
 commonplace tasks, such as grasping and holding a pencil or fork.
     "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 direct 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 Smit (Managing Director) and Theo
 Flipsen (Director R&D) of Polyganics B.V. "Polyganics' transparent peripheral
 nerve guide is a bioresorbable tube that is sutured to both ends of the
 transected nerve and guides the outgrowing nerve in a protective environment.
 Neuroma formation and the ingrowth of fibrous tissue are thus prevented. After
 the nerve function has been restored, the nerve guide is gradually and
 completely resorbed by the body."
     "If this trial is successful, Polyganics has the first commercially
 available transparent nerve guide to be used for the repair of peripheral
 nerves transected in accidents in the upper and lower extremities and other
 parts of the human body, a market with an estimated global potential of over
 $50 million per year. 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 and is expected to be widely accepted by hospitals and individual
 surgeons as an alternative to currently used animal-derived materials."
     The transparent peripheral nerve guide is one of a series of medical
 products based on Polyganics' proprietary synthetic bioresorbable materials
 that exhibit superior properties and offer break-through new alternatives for
 e.g. animal-derived materials. The peripheral nerve guide is Polyganics' first
 product that has entered clinical trials and is expected to receive FDA
 clearance and CE Mark registration in 2003. Meanwhile, Polyganics will start
 additional human trials for two other products in Q4 2002.
     Polyganics B.V., a privately held biomedical company based in the
 Netherlands, develops and manufactures innovative bioresorbable biomaterials
 and a variety of medical devices, including soft tissue regeneration implants,
 drug delivery systems and bioactive coatings. Polyganics is active in several
 areas such as Neurosurgery, Plastic Surgery, Maxillofacial Surgery,
 Ear-Nose-Throat Surgery, Advanced Wound Care and Parenteral Drug Delivery
 Systems. With its well equipped design, engineering and manufacturing centre
 and collaborative partnerships with several academic, clinical and corporate
 research groups, Polyganics designs synthetic biomaterials and new product
 concepts that will be sold globally through strategic alliances and
     Polyganics' novel synthetic bioresorbable products strongly reduce the
 number of medical interventions, thereby improving patient compliance and
 comfort while reducing health care costs. The products under development now
 address markets with a total potential of near 4 billion Euros. Polyganics
 B.V. has its headquarters, manufacturing and research facilities in Groningen,
 The Netherlands. Please visit the Company's website at

SOURCE Polyganics B.V.