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Integra NeuroSciences and GMSmbH Renew LICOX Distribution Agreement; Revolutionary Device to Measure Cerebral Tissue Oxygen Pressure.


Business Editors/Health & Medical Writers

PLAINSBORO, N.J.--(BUSINESS WIRE)--Sept. 6, 2000

Integra LifeSciences Integra LifeSciences Corporation, based in Plainsboro, New Jersey, is a leading medical technology company. Integra is a publicly traded company and is listed under the symbol IART.  Holdings Corporation (Nasdaq: IART IART Impact Area Review Team
IART Intraatrial Reentrant Tachycardia
IART Initial Access Response Time (IBM)
IART Image-Guided Adaptive Radiation Therapy
) today announced that its Integra NeuroSciences division has extended for seven years its exclusive sales and distribution agreement with German manufacturer GMSmbH.

The agreement provides for the introduction of GMS's LICOX(R) cerebral tissue oxygen monitoring products in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , Canada, Mexico, England, and Central and South America. The two companies also plan to implement a strategic marketing and clinical development cooperation in important Asian and European markets.

The LICOX(R) products have CE Mark Certification and are approved for clinical use in Europe, Australia and New Zealand New Zealand (zē`lənd), island country (2005 est. pop. 4,035,000), 104,454 sq mi (270,534 sq km), in the S Pacific Ocean, over 1,000 mi (1,600 km) SE of Australia. The capital is Wellington; the largest city and leading port is Auckland. . In the European Community, the LICOX(R) Brain Oxygen Monitoring System has proven useful in monitoring cerebral tissue oxygen in neurotrauma, subarachnoid hemorrhage Subarachnoid Hemorrhage Definition

A subarachnoid hemorrhage is an abnormal and very dangerous condition in which blood collects beneath the arachnoid mater, a membrane that covers the brain.
, stroke and vascular compromise.

The LICOX(R) system may also be used to monitor oxygen availability in a working myocardium myocardium /myo·car·di·um/ (-kahr´de-um) the middle and thickest layer of the heart wall, composed of cardiac muscle.

hibernating myocardium  see myocardial hibernation, under
, organ transplants, osteomyocutaneous transplants and septic shock Septic Shock Definition

Septic shock is a potentially lethal drop in blood pressure due to the presence of bacteria in the blood.
Description

Septic shock is a possible consequence of bacteremia, or bacteria in the bloodstream.
. Other uses include validation of irradiation therapy, dermatosclerosis diagnosis, disturbed wound healing wound healing Physiology The repair of a wound Steps Inflammation, repair and closure, remodeling, final healing; repair of incisions may be either simple–'clean' wounds with little loss of tissue heal by 'primary intention', or 'dirty' wounds heal by , skeletal muscle assessments, synovitis synovitis /syno·vi·tis/ (sin?o-vi´tis) inflammation of a synovial membrane, usually painful, particularly on motion, and characterized by fluctuating swelling, due to effusion in a synovial sac.  and arthrosis arthrosis /ar·thro·sis/ (ahr-thro´sis)
1. joint.

2. arthropathy.


ar·thro·sis
n. pl. ar·thro·ses
1. An articulation between bones.

2.
 investigation.

"Integra NeuroSciences, through its Camino(R) and Ventrix(R) lines, is already a leader in providing products that measure clinically important brain parameters," said Stuart M. Essig, Integra's President and Chief Executive Officer. "When approved, LICOX(R) will give us another leading and complimentary technology to support doctors and nurses and their patients in the neuro intensive care unit."

Dr. Wolfgang Fleckenstein, President and Chief Executive Officer of GMSmbH commented, "We are delighted to be working with Integra NeuroSciences. This partnership with GMS GMS Greater Mekong Subregion
GMS Global Mobile (Communications) System
GMS Guild Management System
GMS General Medical Services
GMS Global Management System (Sonicwall)
GMS GroupWise Mobile Server
 for LICOX(R) and other GMS products further establishes Integra NeuroSciences as the worldwide industry leader in neurotrauma. Integra already sets the standard in intracranial pressure intracranial pressure
n. Abbr. ICP
Pressure within the cranial cavity.


intracranial pressure (in´tr
 monitoring. GMS has developed a leadership position in cerebral tissue oxygen pressure."

The LICOX(R) is a system for continuous quantitative regional monitoring of dissolved oxygen and temperature in body fluids and tissue. These measurements are valuable diagnostic and prognostic indicators with important clinical and research applications. The LICOX(R) is the culmination of over ten years of developmental refinement.

System calibration is fast and simple, electrode accuracy is excellent and readings are corrected for temperature fluctuations every two seconds. The small size and long-term stability of the sensors make the system useful for critical care and intraoperative monitoring.

The LICOX(R) system is a universal clinical tissue oxygen and temperature monitor. Its REVOXODE(TM) micro catheter probes are precalibrated and are supplied with their individual calibration data electronically stored on a smart card. The REVOXODE(TM) probes are simple to use and accurate even in long-term use.

The accuracy of the LICOX(R) system at low critical thresholds of tissue oxygenation oxygenation /ox·y·gen·a·tion/ (ok?si-je-na´shun)
1. the act or process of adding oxygen.

2. the result of having oxygen added.
 is essential for reliable diagnosis and treatment control of tissue hypoxia hypoxia

Condition in which tissues are starved of oxygen. The extreme is anoxia (absence of oxygen). There are four types: hypoxemic, from low blood oxygen content (e.g., in altitude sickness); anemic, from low blood oxygen-carrying capacity (e.g.
 and ischemia.

Integra NeuroSciences designs, manufactures and sells implants, instruments and monitors used in neurosurgery neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system.

neu·ro·sur·ger·y
n.
Surgery on any part of the nervous system.
 and intensive care units, primarily for the treatment of neurosurgical trauma and surgery. Together with its seven-person medical education unit, Integra NeuroSciences' direct selling effort has reached 50 field personnel in the United States and England.

Integra NeuroSciences also sells its products in over 80 countries worldwide through a network of approximately 100 international distributors.

Integra LifeSciences Holdings Corporation has its corporate headquarters in Plainsboro, NJ. Manufacturing and research facilities are also located in San Diego, CA, Anasco, Puerto Rico, Andover, England and Exton, PA. The Company has approximately 485 permanent employees. Please visit the Company's Website at (http://www.integra-LS.com).

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted or pro-forma results. Achieving the anticipated benefits of new products and technologies will depend in part upon whether necessary governmental approvals are obtained, the new product is manufactured and priced consistently with the commercial requirements of the market, and whether marketing and sales efforts are successful, none of which may be assured. In addition, the economic, competitive, governmental, technological and other factors identified in Integra's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for 1999 and subsequent filings, could affect actual results.

Source: Integra LifeSciences Holdings Corporation

Integra NeuroSciences

Fact Sheet

Integra NeuroSciences is the neurosurgery division of Integra LifeSciences Holdings Corporation. Integra NeuroSciences has consistently brought innovative technologies to market. Integra NeuroSciences products are as follows:


Products          Use                         Brand

Intracranial      For continuous pressure,    Camino(R); Clinical
monitoring and    temperature, and oxygen     Neuro Systems(TM);
drainage          monitoring of the brain     Ventrix(R) intracranial
                  following injury            pressure monitoring and
                                              drainage systems;
                                              LICOX(R) Brain Oxygen
                                              Monitoring System

Neurosurgical     For removal of tumors       Selector(R) Integra
systems                                       Ultrasonic Aspirator;
                                              Integra Coblation(R)

Neurosurgical     Specifically designed for   Heyer-Schulte(R);
shunts            the maintenance of the      Novus(R); Spetzler(R);
                  chronic condition           Pudenz(R); LPV-II(TM)
                  hydrocephalus, i.e. excess  shunting systems
                  pressure in the brain

Neuroendoscopy    For minimally invasive      Neuro Navigational(R)
                  surgical access to the      flexible endoscopes for
                  brain                       neurosurgery

Neurosurgical     Specialized surgical        Redmond(TM)-Ruggles(TM)
instruments       instruments for             neurosurgical and
                  neurosurgeons               spinal instruments

Dural grafts      For repair of damage to     DuraGen(TM) Dural Graft
                  the dura mater, the         Matrix
                  membrane that encases the
                  brain and spinal column
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