PLAINSBORO, N.J., Sept. 23, 2002 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) today announced that it has acquired certain assets, including the NeuroSensor(TM) monitor and rights to certain intellectual property from Novus Monitoring Limited of the United Kingdom. The parties also entered into a related development agreement pursuant to which Novus will conduct certain clinical studies, continue development of an additional product for use in the neuromonitoring field, and design and transfer to Integra, a validated manufacturing process for these products.
The NeuroSensor(TM) monitoring system measures both intracranial pressure and cerebral blood flow using a single combined probe and an electronic monitor for data display. Cerebral blood flow is considered to be an important parameter for monitoring cerebral auto-regulation and, when combined with the measurement of intracranial pressure, is expected to facilitate improved patient care and clinical management with applications in neuro-trauma, cerebrovascular disease and post-operative neurosurgical treatment. The NeuroSensor(TM) product has not yet been launched, pending the results of clinical trials that are scheduled to begin in 2003 and other factors. It received 510(k) clearance from the United States Food and Drug Administration in February 2002.
Integra NeuroSciences will feature the NeuroSensor(TM) product at the annual meeting of the Congress of Neurological Surgeons in Philadelphia this week. The developers of the NeuroSensor(TM) system, Professor Peter Gibson and Dr. James Petite, will be present at the Integra NeuroSciences booth to discuss the NeuroSensor(TM) system.
"Integra has a long and successful history in the field of neuromonitoring with our Camino(R) and Ventrix(R) product lines," said Stuart M. Essig, Integra's Chief Executive Officer. "The technology that we have acquired provides Integra with a valuable platform to develop and launch innovative, new products for measuring clinically important brain parameters, such as intracranial pressure and cerebral blood flow. It is our goal to continue to advance the treatment of brain injuries and we look forward to working with Novus to use the acquired technology in the development of additional neuromonitoring products."
Integra paid $3.5 million in cash at closing for the acquired business and related technology and the services to be provided by Novus under the development agreement. Integra has also agreed to pay an additional $1.5 million upon the achievement of a product development milestone and up to $2.5 million based upon sales of acquired and developed products.
Because development of one of the acquired product technologies is in process and does not have regulatory clearance, Integra is expected to record an in-process research and development charge in the third quarter ended September 30, 2002 related to this technology. The amount of the charge is currently under evaluation.
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. Integra has its corporate headquarters in Plainsboro, New Jersey, with manufacturing and research facilities located throughout the world. Integra has approximately 750 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 Integra's expectations for the clinical efficacy of the NeuroSensor(TM) system, the timing of the initiation of clinical trials for the NeuroSensor(TM) product, the launch of the NeuroSensor(TM) product, the development of additional medical devices using the acquired technology, and the Company's current estimate for the amount of the in-process research and development charge to be recorded in the third quarter ended September 30, 2002. 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 cerebral blood flow as a clinically relevant brain parameter for treatment may affect the launch of the NeuroSensor(TM) product, the efforts of Novus may affect the development of additional medical devices using the acquired technology, and the review by external auditors and regulatory agencies of the Company's assumptions used to estimate the in-process research and development charge may affect the charge to be recorded. 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.