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.
CONTACT: Integra LifeSciences Holdings Corporation, Plainsboro John B. Henneman, III, 609/936-2481 firstname.lastname@example.org or John Bostjancic, 609/936-2239 jbostjancic@integra-Ls.com