C O R P O R A T E B A C K G R O U N D E R For information contact: Joni Morford, Communicore 714/721-8081 jmorford@communicore.com ORQUEST, INC. The worldwide orthopedic market is in the early stages of a revolution which will create new therapeutic options and reduce the morbidity and hospital stays associated with current procedures. This revolution is being driven by the new field of orthobiologics which combines an understanding of tissue biology, material sciences and the new generation of growth factors to create breakthrough products. These products have the potential to enable the orthopedic surgeon to restructure existing therapies in a less invasive manner increasing patient satisfaction and reducing therapy costs. The new approach to therapies will potentially increase the volume of procedures as patients with chronic pain and disability find the new methods more attractive with a promise of an improved quality of life. Orquest, Inc. was founded in 1994 to establish a new paradigm in orthobiologics by aggressively developing a portfolio of innovative and proprietary products using proven, naturally occurring biomaterials. Orquest's strategy is to develop a portfolio of matrix-based products which will address targeted needs in bone and cartilage. Orquest's approach is unique because it concentrates on neither growth factors nor grafting materials alone, but rather seeks to use its broad expertise to engineer products capable of integrating the most effective properties of both. Orquest has returned to basic tissue biology to create advanced matrices which are conducive to the body's natural remodeling and tissue regeneration processes. These matrices more closely mimic the natural environment for the cells which are required in the healing process and as such are also a more efficient partner for growth factors in promoting tissue regeneration. Orquest has developed two proprietary platform technologies, an implantable matrix technology and an injectable matrix technology. Each forms the basis for multiple product opportunities, specifically designed for selected orthopedic indications. Each of these technologies has been advanced to yield a specific clinical product targeted at a major orthopedic indication. The Company's initial product Healosª is an implantable bone grafting matrix designed to reduce the morbidity and cost associated with current spinal fusion procedures. The Company's second product Ossigelª is an injectable formulation developed to accelerate fresh fracture healing. Orquest's first two products address the needs of the two fastest growing segments in the orthopedic market, spinal fusion and fracture management, and together represent a current worldwide opportunity well over $2 billion. Healos, Orquest's first matrix-based product mimics the inherent properties of natural bone. Healos is fabricated from collagen fibrils coated with hydroxyapatite (the primary components of native bone), cast in a porous, open cell matrix with characteristics that facilitate handling and placement during surgery. Healos was developed to eliminate a painful and expensive secondary surgery routinely performed in spinal fusion and other procedures requiring bone grafting. This additional surgery involves the removal of bone material, called autograft, from the patient's hip. The disadvantages of this surgery include increased surgical time, added cost ($3,000 - $5,000 per procedure) and risks of post-surgical complications such as infection and chronic hip pain. The majority of patients have hip pain at the harvest site, many lasting up to a year or more following surgery. Surgical harvesting of autograft, the current medical standard, was performed in an estimated 80% of the 225,000 spinal fusion procedures in 1996. No alternative bone graft material has been able to match the clinical performance of autograft - thus autograft continues to be used in spite of its disadvantages. Healos was designed to mimic the natural bone matrix, composition and characteristics. Like autograft, it promotes the natural bone healing processes and is similarly completely replaced by newly formed bone. Healos is currently in clinical trials for spinal fusion with standard instrumentation in Europe; U.S. trials are expected to begin in late 1997. In addition, through a strategic alliance with SpineTech, the leading interbody fusion cage company in the United States, Healos will be combined with the BAKª spinal interbody fusion cage system to facilitate spinal fusion. Interbody fusion cages are the most exciting new instrumentation in spinal fusion because they offer the potential to convert this extensive surgical procedure to a laparoscopic, minimally invasive technique. Currently interbody fusion cages must be filled with autograft, thus retaining one of the most undesirable features of the existing procedure. By combining Healos with the interbody fusion cages, Orquest and SpineTech expect to realize the full potential of this new therapeutic option yielding significant patient and payor benefit. Orquest and SpineTech will initiate the U.S. clinical trials mid 1997. Additionally, Hoechst Marion Roussel (HMR) and Orquest are developing a next generation implantable bone grafting product utilizing HMR's recombinant bone inductive protein and the Healos matrix technology. In preclinical studies, this product has demonstrated the potential to exceed the goal of matching the performance of autograft through more rapid induction and remodeling of newly formed bone. While this product will carry the extra cost of incorporating the growth factor, the Company believes it will expand bone grafting indications in orthopedics. One such example is to expand the use of non-instrumented spinal fusion where rapid stabilization of spine is essential for fusion. Preclinical studies are nearing completion under this R&D collaboration and U.S. clinical trials are anticipated by late 1998. Ossigel, Orquest's second matrix-based product represents a breakthrough method for accelerating fracture repair. Ossigel was developed to shorten fracture healing time, which is particularly a problem in the aging population. In addition, tibial fractures are poorly vascularized and healing is delayed. Prolonged healing time with its associated complications is the leading cause of morbidity with these fractures and significantly increases the cost of treatment. Based on patient profile and fracture characteristics, physicians routinely diagnose individuals who will have prolonged or compromised healing, but to date have no alternative medical management options. Ossigel is an injectable matrix formulated from two naturally occurring materials found in the body, hyaluronic acid and basic fibroblast growth factor. With a single administration into a fresh fracture, Ossigel significantly accelerates the fracture healing process by stimulating the formation of the callus. The callus formation is critical as it provides early stabilization of the fracture while creating the environment for the healing process to occur. In 1996, there were an estimated 24 million fractures worldwide, with 5.5 - 6.0 million in the United States alone. The majority of these were closed fractures (bone did not break through the surface of the skin) and healed normally through the use of fracture immobilization, such as a cast. The normal healing time ranges from weeks to several months, but can sometimes take years depending on the location and the severity of the fracture. An estimated 20% of all fractures have complications which can further delay the fracture healing resulting in patient's prolonged pain, incremental costs, and delays in their return to normal activities. Ossigel accelerates fracture healing, thereby reducing costs, potential complications and allowing patients to more quickly return to normal activities. Orquest is completing preclinical evaluation and expects to begin Ossigel's human clinical trials in the United States in the second half of 1997. The Company believes that additional matrix-based products will be necessary to meet the wide range of demands in the management of bone and cartilage conditions. Orquest has several new proprietary matrices under development for targeted indications, such as cartilage regeneration. An NIH Small Business Innovative Research (SBIR) grant has been awarded to Orquest to further develop a matrix for cartilage regeneration. Orquest's competitive advantage lies in its core patented technologies for implantable and injectable matrices for bone and cartilage regeneration. The Company has been aggressively acquiring access to new technologies, including growth factors, through licensing and strategic partnering. To date, the Company holds six pending patent applications covering its implantable and injectable matrix technologies, an exclusive, worldwide license to two issued and three pending patents covering mineralized collagen and a worldwide license (excluding the Far East) to use the basic fibroblast growth factor (bFGF) for orthopedic applications covered by a series of U.S. and European patents, the majority of which have been issued. The Company's strategy is to develop a portfolio of matrix-based products which will address specific targeted needs in bone and cartilage. Strategic alliances, like HMR and SpineTech, will provide Orquest with access to complimentary technologies and growth factors to develop additional products that meet these needs. Commercialization of these products will be accomplished through partnerships in the international markets and through a combination of Orquest's and strategic partner's resources in the United States. Orquest has built a strong, balanced management team with significant business and industry experience. Dr. Estes, President and Chief Executive Officer, has over 20 years in positions of increasing responsibility in the global medical device industry developing and establishing high technology businesses in the cardiovascular field with American Supply Corporation/Baxter Healthcare. Dr. Seyedin, the Founder and Chairman, has over 16 years of industry experience in tissue biology with emphasis in bone and cartilage, including 8 years managing the bone repair program at Collagen Corporation. Dr. Poser, the Vice President of Research and Development, is well known for his work in bone chemistry and skeletal metabolism. Mr. Carlson, the Vice President of Marketing, Sales and Operations, has 15 years of industry experience in marketing and strategic planning. The Company's management, vision and technical strengths have allowed it to recognize the opportunities presented by the new field of orthobiologics. The combined experience of the team has enabled it to rapidly create technologies, develop products and enter clinical trials. End of document.