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.