Integra NeuroSciences Announces New Product Launches at the Congress of Neurological Surgeons Meeting
The following product lines will be highlighted at the meeting:
-- The NeuraGen™ Nerve Guide, an absorbable collagen implant
for the repair of severed peripheral nerves in the
extremities, received FDA 510(k) clearance in June. The
NeuraGen™ product is designed to provide a protective
environment for peripheral nerve repair after injury and to
provide a conduit through which regenerating axons can bridge
the injury. The Integra NeuroSciences sales force will
complete its sales training on this product in October.
Integra will also introduce the product at the meeting for the
American Society for Surgery of the Hand in Baltimore,
Maryland later this week. The Company estimates that the
annual worldwide market potential for the repair of peripheral
nerve injuries approximates $40 million.
-- Integra NeuroSciences line of cranial access kits, ventricular
catheters and external ventricular drainage (EVD) systems will
now be marketed as Integra Systems of CSF Drainage and Cranial
Access, which represents the consolidation of Integra's former
Heyer-Schulte®, Clinical NeuroSystems™ and Camino®
family of drainage and cranial access products. These products
will continue to be marketed under the Hermetic® and
MoniTorr ICP™ External CSF Drainage Systems brand names as
part of the new Integra family of neuro-trauma products. The
Hermetic Plus™ system, our newest, most advanced panel
mount EVD system, is the latest addition to Integra's
comprehensive product portfolio. This new drainage system,
along with our cranial access kits, have been improved to
incorporate "needle-less" ports and safety syringes in advance
of federal regulations requiring these enhancements.
-- The Ventrix® True Tech Catheter, the only advanced fiber
optic intracranial pressure monitoring and drainage catheter
designed to tunnel away from the brain, received FDA 510(k)
clearance earlier this year and has been introduced into nine
new domestic accounts since its targeted launch in April. The
True Tech catheter is being launched nationally at the
Congress of Neurological Surgeons meeting this week and the
Company is seeking CE Mark Certification for the launch of the
product into Europe. It is estimated that there are 400,000
cases of head trauma in the United States each year, of which
the portion that requires monitoring and intervention
represents products sales today in excess of $40 million.
Approximately 50% of this market is currently served by
advanced ICP monitoring systems, such as those using fiber
optics, with the remaining 50% served by fluid-filled systems
that tunnel away from the brain. The Ventrix® True Tech
Catheter now provides the neurosurgeon with an advanced ICP
monitoring system that allows for the proven clinical method
of tunneling away from the brain similar to fluid-filled
systems.
-- The LICOX® Brain Tissue Oxygen Monitoring System, which was
launched in April 2001, provides continuous quantitative
regional monitoring of dissolved oxygen and temperature in
cerebral tissues. These measurements are valuable diagnostic
and prognostic indicators with important clinical and research
applications. Since its launch of the LICOX® product, the
Company has taken a leadership role in working with
institutions to develop standards of care for patient
interventions using the LICOX® product technology as a new
modality for monitoring critically ill patients. The Company's
estimate of the market for the LICOX® product technology in
the United States is approximately $10 to $20 million for the
initial purchase of monitors and $10 to $15 million annually
for the disposable catheters.
"Integra NeuroSciences has become a leader in the neurosurgical market through
its ability to bring innovative, new products such as these to market," remarked
Stuart Essig, Integra's President and Chief Executive Officer. "These new
product offerings will increase Integra's reputation as a one-stop shop for the
neurosurgeon and neuro nurse. We will continue to develop and launch new
products and seek distribution rights to additional products that can be
leveraged through our growing domestic and international sales organization,
which now totals over 65 direct salespeople and clinical educators in the United
States and Europe."
Integra NeuroSciences designs, manufactures and sells implants, devices and monitors used in neurosurgery, neurotrauma, and related critical care. Integra NeuroSciences also sells its products in approximately 80 countries worldwide through a network of international distributors.
Integra LifeSciences Holdings Corporation, headquartered in Plainsboro, New Jersey, has approximately 585 permanent employees. Please visit the Company's website at www.Integra-LS.com.
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements relating to the market launch of new products for use in new, approved therapeutic applications and the potential market size for these products, and the Company's efforts to develop and obtain distribution rights to new products. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, the willingness of physicians to adopt new products may affect the launch of and potential market size for these products, and the Company's research and business development efforts may affect its ability to develop or obtain distribution rights to new products in the future. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Risk Factors" included in the Business section of Integra's Annual Report on Form 10-K/A for the year ended December 31, 2000 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
www.integra-Ls.com
CONTACT: Integra LifeSciences Holdings Corporation, Plainsboro
John B. Henneman, III, 609/936-2481
jhenneman@integra-ls.com
or
John Bostjancic, 609/936-2239
jbostjancic@integra-Ls.com