Published: May 03, 2004
Integra LifeSciences Launches LICOX(R) PMO Catheter
PLAINSBORO, N.J., May 3, 2004 -- Integra LifeSciences Holdings Corporation today announced that it plans to market and sell the LICOX(R) PMO, a next-generation catheter and introducer for use with the Integra LICOX(R) Brain Tissue Oxygen Monitoring System. Integra NeuroSciences has received 510K clearance from the United States Food and Drug Administration to market the LICOX(R) PMO in the United States. Integra, which is featuring the LICOX PMO at the 2004 American Association of Neurological Surgeons Annual Meeting in Orlando, Florida this week, plans to sell this product in the United States through its Integra NeuroSciences(TM) sales force.
The LICOX Brain Tissue Oxygen Monitoring System allows for continuous qualitative regional monitoring of dissolved oxygen and temperature in cerebral tissues following injury or neurosurgical procedures. The LICOX PMO catheter and introducer offer several advantages over the catheter currently used as a part of the system. It is designed to measure oxygen and temperature through a single combined probe, a feature that decreases the time required for the insertion procedure. It also utilizes a larger sampling area, and therefore provides more data for use in monitoring oxygen and temperature levels in the brain.
A low level of oxygen in the brain is related to increased mortality in traumatic brain injury. Prior to the introduction of LICOX, neurosurgeons measured cerebral perfusion pressure (CPP) as a surrogate for oxygen levels in the brain. Since the introduction of LICOX, neurosurgeons have documented cases in which CPP was normal while oxygen levels were dangerously low. Neurosurgeons have responded favorably to utilizing the LICOX Brain Tissue Oxygen Monitoring System as a tool for the management of traumatic brain injury.
"The LICOX PMO is an important addition to our LICOX product line," said Deborah Leonetti, Integra's Vice President of Marketing. "The enhancements it offers to our current product line provide an example of Integra's ability to respond to the needs of physicians, which has made us a market leader in neurosurgery."
Integra LifeSciences Holdings Corporation is a diversified medical technology company that develops, manufactures, and markets medical devices for use in a variety of applications. The primary applications for our products are neuro-trauma and neurosurgery, plastic and reconstructive surgery and general surgery. Integra is a leader in applying the principles of biotechnology to medical devices that improve patients' quality of life. Our corporate headquarters are in Plainsboro, New Jersey, and we have manufacturing and research facilities located throughout the world. We have approximately 1,000 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 future use of the LICOX PMO. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, physicians' willingness to use the LICOX PMO may affect the prospects for its use in clinical procedures. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Factors Than May Affect Our Future Performance" included in the Business section of Integra's Annual Report on Form 10-K for the year ended December 31, 2003 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
CONTACT: Integra LifeSciences Holdings Corporation
John B. Henneman, III
Executive Vice President
Chief Administrative Officer
(609) 936-2481
jhenneman@Integra-LS.com
Maria Platsis
Director of Corporate Development
and Investor Relations
(609) 936-2333
mplatsis@Integra-LS.com
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