PLAINSBORO, N.J. 9/29/2005 05:00 AM GMT (TransWorldNews)
Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today that it has acquired the intellectual property estate of Eunoe, Inc. Prior to ceasing operations, Eunoe, Inc. was engaged in the development of its innovative COGNIShunt(R) system for the treatment of Alzheimer's disease patients. The COGNIShunt(R) system was evaluated under an FDA Investigational Device Exemption.
"The acquisition of the Eunoe intellectual property estate and clinical trial data considerably extends our technology base relevant to the management of conditions that require regulation of Cerebrospinal Fluid (CSF) flow within the brain. The traditional application of this technology is for the treatment of hydrocephalus, which is currently one of our key markets," said Simon Archibald, Ph.D., Integra's Chief Scientific Officer. "The core of Eunoe's approach is the modulation of the chemical environment experienced by neurons in the ageing brain. The COGNIShunt(R) system is intended to regulate a low but steady flow of CSF from the brain. The increased CSF flow is intended to stimulate CSF production and thereby improve clearance of neurotoxins, which are believed to contribute to the progression of Alzheimer's disease, from the CSF. The team at Eunoe published the promising results from their Phase I/II feasibility studies in the Oct. 22, 2002 issue of the journal Neurology."
The nervous system produces CSF that bathes the brain, clears waste products of brain cell metabolism, and provides the optimal environment for brain cell function. In normal aging, it is believed that CSF production declines. In Alzheimer's disease patients, normal aging may be worsened by amyloid deposition in the cells that produce and clear CSF, leading to marked CSF stagnation. The resulting accumulation of toxic substances may be a leading contributor to the progression of Alzheimer's disease.
The COGNIShunt System is designed to increase the flow of CSF and improve clearance of potential neurotoxins, which are believed to contribute to the progression of Alzheimer's disease, from the CSF. The specially engineered fluid regulating shunt diverts CSF from the brain, via a catheter, to the peritoneal cavity, where it is absorbed by the body. In the clinical trial, the surgical implantation of the shunt was conducted under general anesthesia and patients often went home the day of, or the day after, the procedure. The COGNIShunt(R) system has not received FDA clearance or approval for sale.
Recent clinical research suggests that impaired clearance of extracellular fluids in the brain and the resulting accumulation of neurotoxic proteins, may play a significant role in the progression of Alzheimer's disease. Current available therapies improve symptoms but are not thought to delay the underlying progression of the disease.
The Eunoe Phase I/II feasibility study demonstrated that the procedure and COGNIShunt System were safe and well tolerated in Alzheimer's disease patients. The data showed a marked difference in mental function over time, with better preservation of mental ability in shunted patients versus the control group. In addition, CSF levels of the potentially neurotoxic proteins found in Alzheimer's disease brain lesions, such as MAP-Tau and (beta)-Amyloid (1-42), declined in shunted patients and remained lower than their initial levels, even after 12 months. Importantly, no subject had symptoms of over drainage, the side effect the shunt was specifically designed to avoid.
Based on the encouraging preliminary data, Eunoe entered into a pivotal study that eventually recruited 215 patients at 22 sites. On December 8, 2003, enrollment to the study was halted by the company based on the results of a planned interim analysis. The analysis indicated that the new sample size estimation was greater than the stopping rule number previously agreed upon with FDA. Although the analysis of the more sensitive measure of mental function (the MDRS) demonstrated a difference between the two groups in favor of the COGNIShunt group, analysis of the global scale (GDS) did not show a difference; therefore, the pivotal study, as designed, would not have been sufficient to demonstrate efficacy in support of a US Pre-Market Approval Application. All implanted subjects continued with per-protocol study procedures while Eunoe continued to analyze the endpoint measures data. On June 14, 2004, the study was closed based on the results of the second interim analysis which showed that the difference between treatment groups for the MDRS, while still favoring the COGNIShunt group, was less than that of the first interim analysis.
Ray Larkin, the chief executive officer of Eunoe, Inc. remarked, "I am pleased that Integra has acquired Eunoe, Inc.'s intellectual property estate. Integra has a strong reputation for bringing innovative medical devices to the neurosciences marketplace, and I look forward to them advancing this important technology."
Integra LifeSciences Holdings Corporation is a diversified medical technology company. Integra develops, manufactures, and markets medical devices used in a variety of applications. The primary applications for our products are neuro-trauma and neurosurgery, 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 research, manufacturing and distribution facilities located throughout the world. We have approximately 1,300 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 expectations for future development of products based on the acquired intellectual property and the clinical applications of such products. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Among other things, Integra's development efforts and its ability to obtain regulatory approval to market future products based on the acquired intellectual property could affect the success and timing of commercialization of the acquired intellectual property and the results of clinical trials involving products based on the acquired intellectual property could affect the use of such products in desired clinical applications. In addition, the economic, competitive, governmental, technological and other factors identified under the heading "Factors That 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, 2004 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
Senior Director of Corporate Development
and Investor Relations