Integra LifeSciences Announces Completion of Grant in Advanced Biomaterials Program; Device Master File Submitted to FDA
Funded by a three-year grant from the National Institute of Standards and Technology's Advanced Technology Program, this development program has yielded a fully synthetic, resorbable polymer technology platform that encompasses a broad range of tissue engineering applications that require tailored control of degradation rates.
The material is designed to degrade into naturally occurring, non-inflammatory by-products. Furthermore, device fabrication by traditional techniques such as compression molding, injection molding and extrusion can be readily achieved. Recently issued U.S. Patent No. 6,120,491 details the composition of matter and uses for this platform technology.
Integra LifeSciences has licensed this and related patented technologies from Rutgers University for all applications, and continues to work in collaboration with the technology's co-inventor, Dr. Joachim Kohn, Professor of Chemistry at Rutgers University and Director of the New Jersey Center for Biomaterials to develop its applications.
Investments in the manufacturing, regulatory, and development of this technology since the inception of the program in 1993 has totaled approximately $8.0 million, a large portion of which was funded through external grants.
Stuart Essig, President and Chief Executive Officer of Integra LifeSciences, commented "This program demonstrates Integra's continued commitment to advancing its biomaterials-based technologies to develop innovative medical devices. We have designed a well-defined and commercially scalable manufacturing process to prepare the product, which was sold commercially for the first time in February 2000."
Since 1998, Integra has been involved in a strategic alliance with Bionx Implants, Inc. for the development of fixation devices using Integra's tyrosine-derived polymer technology.
Products covered under the alliance with Bionx include a resorbable line of screws, plates, pins, wedges and nails used for the fixation or alignment of fractures or osteotomies in all areas of the musculoskeletal system except the spine and cranium.
Integra is continuing and has concluded several other materials transfer and research collaborations for tyrosine-derived polycarbonates during the past year. These collaborations, which include evaluation for use in orthopedic, craniomaxillofacial, spinal and drug delivery applications, have progressed through animal studies. To date no human studies have been undertaken.
The Company has produced a Device Master File for the polymer technology and filed it with the FDA in April 2001. Information contained in the Device Master File may be used by Integra's strategic partners for Premarket Approval Applications, Investigational Device Exemptions, and 510(k) Premarket Notification submissions.
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.
The Company has its corporate headquarters in Plainsboro, New Jersey, with manufacturing and research facilities located throughout the world. The Company has approximately 550 permanent employees. Please visit the Company's website at 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 factors include, but are not limited to, statements concerning product development programs and regulatory approval and market acceptance of new products and their use in approved therapeutic applications. 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 strategic alliance partners to continue development programs may affect product development and regulatory approval activities, competing products and product performance may affect market acceptance of new products, and the willingness of practitioners to adopt new product technologies may affect their use in approved therapeutic applications. 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/A for the year ended December 31, 2000 and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results.
Source: Integra LifeSciences Holdings Corporation
CONTACT: Integra LifeSciences Holdings Corporation, Plainsboro John B. Henneman, III, 609/936-2481 firstname.lastname@example.org or John Bostjancic, 609/936-2239 email@example.com