Integra LifeSciences Launches KraniOS™ Cranial Closure System
PLAINSBORO, N.J., July 27, 2004 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it plans to market and sell the KraniOS™ Cranial Closure System, a complete set of implants and tools necessary to perform successful cranial flap closure. Integra NeuroSciences has received 510K clearance from the United States Food and Drug Administration to market the KraniOS™ System in the United States. Integra plans to begin selling this product line next month through its domestic Integra NeuroSciences™ sales force.
The KraniOS™ Cranial Closure System, which was internally developed by Integra, consists of titanium plates, screws and instruments used to close cranial bone flaps. The system features low-profile titanium implants for reduced palpability and screws designed with a head that allows for stable insertion. The KraniOS™ screws also have the strength to minimize stripping while maintaining a low profile.
"The KraniOS™ System is a very important addition to our product line," said Deborah Leonetti, Integra's Senior Vice President of Marketing. "It rounds out our existing neurosurgical product lines, which include cranial access kits, specialty neurosurgical instruments, and a complete line of dural closure products. Our sales force is enthusiastic about the opportunity to sell the KraniOS™ System, which addresses the cranial closure market. We are excited by the response of neurosurgeons who have had an opportunity to evaluate the KraniOS™ System."
Based on available procedure data, Integra estimates that the United States cranial closure market is approximately $80 million.
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 1,100 employees. Please visit our website at (http://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 concerning the future use of the KraniOS™ Cranial Closure System. 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 use the KraniOS™ Cranial Closure System 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:
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