March 30, 1999

OSferion Bone Replacement Material

Unprecedented new artificial bone replacement material Superior bioaffinity and osteoconduction promote maximum absorption and replacement by natural bone Proven efficacy in wide-ranging clinical studies Initial introduction in the Japanese market

Ministry of Health and Welfare medical device approval No. 20700BZZ00418000

OSferion Bone Replacement		OSferion Bone Replacement Material

Summary

Olympus Optical Co., Ltd. is pleased to introduce its innovative OSferion artificial bone replacement material in the Japanese market. The release marks the company's expansion into a promising new segment. OSferion's principal ingredient is Beta-TCP (Beta-tricalcium phosphate) of higher purity than any other product available in Japan, as of March 29, 1999. It is suited to treating bone fractures, tumors and a range of other problems. After it is grafted into the bone, the innovative material is absorbed and replaced during regeneration. With its demonstrated efficacy, OSferion holds enormous promise in improving both treatment and the patient's quality of life. Extremely positive results have already been reported in a number of clinical studies (see figures 1).

Preparing for Growth

Available in Japan from April 1, OSferion in A1-size (10 x 10 x 10 mm) is priced at ¥20,000. With the market's growth potential, Olympus has set the first year's sales target at ¥100 million. Annual sales are expected to reach ¥1 billion in five years. Marketing will focus on OSferion's clear competitive advantages. Plans include exhibits at major conferences in orthopedic medicine, beginning with the 72nd Annual Meeting of the Japanese Orthopaedic Association on April 8 at Pacifico Yokohama.

Major Clinical Advantages

Improving the Patient's Quality of Life

OSferion eliminates the need for bone autotransplantation or minimizes the amount of bone harvested from another part of the body. With this reduced invasiveness, surgery is less traumatic for patients (see note 1). Treatment includes younger patients who are still growing. This advantage reflects the minimal artificial residue as OSferion is absorbed by regenerated bone (see note 2).

Excellent Osteoconduction* and Bioaffinity

OSferion's superior osteoconduction and bioaffinity promote absorption and replacement by natural bone. This efficacy is rooted in the properties of high-purity Beta-TCP and the controlled porous structure. The result is new bone with physical properties almost identical to the original (see note 3).

Simpler and Shorter Follow-up Treatment

During the recovery process, OSferion does not interfere with correcting any abnormalities at the graft point. It also facilitates accurate X-ray examinations since only minimal residual material remains after natural bone replacement. Along with simplifying monitoring during healing, this advantage minimizes the need for long-term follow-up.

* Osteoconduction is the ability to promote bone regeneration by serving as a scaffolding for the growth of new tissue.

Note 1

Conventional therapies sometimes require autotransplantation of bone from another part of the body or harvesting to create a mixture of natural bone and an artificial material. OSferion eases the trauma of these procedures by eliminating the need for autotransplantation or minimizing the amount taken during harvesting. With this reduced surgical invasiveness, the patient enjoys a better quality of life.

Note 2

One of the difficulties of bone replacement is the risk that an artificial material will remain long after treatment. Nearly all OSferion, on the other hand, is absorbed and replaced by natural bone-the key that sets this innovative material apart from others. Since there is almost no residue, the risk of abnormal bone development is greatly reduced, so OSferion can be used safely during a patient's growth years. It also facilitates accurate X-ray examinations. All these differences hold significant benefits for patients.

Note 3

During the process called remodeling, the natural tissue and structure of bone are regenerated. The key is OSferion's outstanding osteoconduction and absorption characteristics. It is made from Beta-TCP-produced to the highest level of purity achieved in Japan up to this point-and porosity has been raised to approximately 75%. This structure ensures that nearly all the innovative material is absorbed and replaced by natural bone during remodeling. As healing progresses, the physical properties of the regenerated bone become almost identical to those of the original. In a typical case, a bone may be damaged by a fracture or other injury, or a bone tumor may have led to surgical removal. When OSferion is grafted to the damaged bone, it creates a scaffolding for the growth of new bone. As this process continues, it is gradually absorbed and replaced by the regenerated bone.

Development of OSferion

Responding to the rapid growth of endosurgery in recent years, Olympus set up the Surgical Products Department within the Endoscope Division. Since its establishment in April 1997, the department has pursued pioneering R&D in endoscopes, therapeutic instruments and related equipment. It is in change of marketing OSferion for applications in orthopedic medicine.

Specifications of OSferion

Molecular formula Ca3(PO4)2 Molecular weight 310.18 Generic name Beta-tricalcium phosphate Appearance and properties White and porous Porosity Approx. 75% Pore diameter 100-400µm

Figure 1

Applications	Effectiveness

Studies conducted by the Orthopedics Dept., the Jikei University School of Medicine & Orthopedics Dept., Nippon Medical School