PLAINSBORO, N.J., Aug. 6, 2002 (PRIMEZONE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) and REVA Medical, Inc. of San Diego, California today announced that they entered into an agreement for REVA to evaluate Integra's tyrosine-derived polycarbonate biomaterials for use as the principal component to manufacture REVA's resorbable cardiovascular stent.
"We at REVA believe that we can leverage our proprietary `slide & lock' design concept to develop a temporary coronary stent," said Gordie Nye, REVA's President and CEO. "The key benefit of a temporary stent is that it won't remain as an impediment to retreatment after patency is restored to the stented site. Our product will deliver and perform just as its steel ancestor, except that it will vanish after its job is done."
According to Dr. Joan Zeltinger, Director of Materials and Biological Science for REVA, the marriage of a slide & lock design and Integra's tyrosine-derived polycarbonates is ideal. "Our low-strain design concept is particularly suited for polymer materials and should allow high-level loading of a broad range of drugs used to treat coronary vascular disease. REVA conducted a careful study of available biomaterials and selected poly(DTE carbonate) because of its superior material properties."
REVA has the exclusive right to evaluate tyrosine-derived polycarbonates for use in cardiovascular stents for a one-year period. On or before the completion of that period, REVA may request that Integra negotiate an exclusive supply agreement for Integra's supply of commercial quantities of tyrosine-derived polycarbonates for use in cardiovascular stenting. In a commercial supply agreement, Integra would have the exclusive right to REVA's resorbable stent technology for intracranial stenting and a co-exclusive right with REVA for carotid stenting. According to industry sources, about 40,000 strokes occur each year due to intracranial stenosis, and many could be prevented using stents. There are no stents approved for intracranial or carotid use in the United States.
Integra has developed its tyrosine-derived polycarbonate biomaterials for commercial manufacture under a license agreement with Rutgers University. Dr. Joachim Kohn, Professor of Chemistry at Rutgers University and Director of the New Jersey Center for Biomaterials, initially led the team of scientists at Rutgers in discovering the tyrosine-derived polycarbonates. Since the inception of a joint industrial/academic collaboration in 1993, Integra has put into place an extensive technical development program, intellectual property portfolio, manufacturing and regulatory filings in support of this technology.
"We are very excited about REVA's interest in pursuing our tyrosine-derived polycarbonate biomaterials," said Stuart M. Essig, Integra's Chief Executive Officer. "REVA's interest in one of Integra's many biomaterial-based products once again confirms Integra's status as a leader in the development of biomaterials for use in medical devices." Integra offers a variety of biomaterial-based products either for sale to the neurosurgical community through its Integra NeuroSciences direct sales force, or through strategic alliances in other therapeutic areas.
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.
REVA Medical, Inc. was founded in 1998 with the mission to deliver novel solutions for the treatment of vascular disease. REVA holds multiple proprietary patents on product designs which promise to revolutionize the cardiovascular industry, leading to market growth and improved patient outcomes. At present, REVA has two stent development programs under way, each which employ a patented and unique stent design. Additionally, REVA's investors have formed a new entity named Happy Valley Medical, Inc., which features a complementary development program involving Ceracor(TM), a proprietary and promising anti-restenotic agent. Both REVA and HVM share a corporate facility located in San Diego, California.
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 and REVA's expectations for the development of medical devices using Integra's tyrosine-derived polycarbonate biomaterials and the execution of commercial supply agreements related to the tyrosine-derived polycarbonate biomaterials. 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 efforts of Integra's development partners may affect development activities for the tyrosine-derived biomaterials, and Integra's ability to manufacture sufficient quantities of the tyrosine-derived polycarbonate biomaterials may affect its ability to enter into commercial supply agreements. 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.