Integra NeuroSciences Announces FDA Clearance to Market a Tunneled Catheter for the LICOX Brain Tissue Oxygen Monitoring System; Product Launch to Begin in Second Quarter
The LICOX® Brain Tissue Oxygen Monitoring System, which was launched by Integra NeuroSciences in the United States in 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. The LICOX® probes, which directly measure intracranial oxygen levels in the brain, can be inserted using the tunneling technique or secured through the use of a bolt.
Presenting at Integra's Investor Forum at the American Association of Neurological Surgeons meeting in Chicago, Stuart M. Essig, Integra's President and Chief Executive Officer, said, "The introduction of the tunneled LICOX® catheter is another important step in Integra NeuroSciences' continued efforts to become the leading provider of the most complete line of products to meet our customers' clinical needs. Now our neurosurgeon and neuro nurse customers can choose between the more traditional tunneling technique or the multi-parameter capabilities of the bolted system for measuring intracranial oxygen using our LICOX® system. Due to the hard work of our regulatory team, we received FDA clearance for the tunneled LICOX® catheter earlier than we had anticipated."
Integra LifeSciences Holdings Corporation develops, manufactures and markets medical devices, implants and biomaterials primarily used in the treatment of cranial and spinal disorders, soft tissue repair and orthopedics. Integra is a leader in applying the principles of biotechnology to medical devices that improve patients' quality of life. The Company has its corporate headquarters in Plainsboro, New Jersey, with manufacturing and research facilities located throughout the world. The Company has approximately 600 permanent employees.
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 concerning the Company's expectations for market launch of the LICOX® Tunneling Catheter. 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 Company's ability to manufacture the LICOX® Tunneling Catheter may affect market launch activities for the product. 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 for the year ended December 31, 2001 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, Senior Vice President,
Chief Administrative Officer
(609) 936-2481
jhenneman@integra-ls.com
John Bostjancic, Senior Director of Finance
(609) 936-2239
jbostjancic@integra-ls.com