Wright Medical Technology, Inc. introduces new material for bone replacement; Medical rediscovery advances sciences of skeletal repair.

ARLINGTON, Tenn.--(BUSINESS WIRE)--Aug. 14, 1996--"The FDA clearance of OSTEOSET(TM) proprietary, specially sourced medical grade calcium sulfate pellets allows Wright Medical Technology, Inc. to provide surgeons the opportunity to treat their patients with a known and reliable bone graft substitute without contamination and without question of biological transfer of viruses and diseases." -- Jack Parr, Ph.D., Executive Vice President of Research and Development at Wright Medical Technology, Inc.

"Medical grade calcium sulfate is truly a biological solution to a biological problem. This material, which is unlike other substitutes, lets the body repair itself and create natural living bone." -- Donald Speer, M.D., Professor of Surgery and Anatomy, University of Arizona Health Sciences Center.

"Calcium sulfate is a material with known properties that is well tolerated by the body and has shown to be an effective bone void filler. Its simplicity also makes it an ideal material to be used for a number of other orthopaedic applications in the future." -- Steven Gitelis, M.D., Associate Chairman, Department of Orthopaedics, Rush Medical College.

The health care community often explores discoveries of the past to find new medical solutions for the future. For Jack Parr, Ph.D., Executive Vice President of Research and Development at Wright Medical Technology, Inc., calcium sulfate is one of those past discoveries that is a solution for many surgeons who want a less painful and virtually risk-free option to bone grafts.

Bone is the second most implanted material in the body (after blood transfusions) and more than 300,000 bone graft procedures are completed annually in the U.S. Bone grafts are used to repair bone defects caused by surgery, tumors, trauma, implant revisions and infections, and also for joint fusion.

The preferred method of treating bone voids involves the use of an autologous graft, in which bone is taken directly from the patient. This graft usually achieves good results, yet requires a second surgery site to retrieve the graft. This second harvesting site is not only costly and time consuming, but can also be more painful to the patient than the primary procedure.

Currently, the second most common bone graft alternative is an allograft from a human bone bank which generally achieves favorable results. This tissue has limited applications because of availability and, unless it is demineralized, it does little to induce new bone growth. The possibility of viral disease transmission is also a concern even though the risk has been reduced by sophisticated testing.

The third alternative for a bone graft procedure is the use of artificial substitutes. The two types of substitutes currently on the U.S. market are a coral-based product and a bovine collagen-based product. These substitutes provide a matrix in which bone can grow, but these types of implants may remain unchanged within the patient's body for an extended period of time and in some cases may result in tissue irritation.

Compared to the current alternatives calcium sulfate is an ideal bone void filler for many bone grafting procedures because it is biocompatible and bioresorbable. As a bioresorbable material, the body will resorb this natural substance and will do so at a rate comparable to the patient's new bone growth, which takes an average of 4 to 8 weeks.

Many surgeons are encouraged about the possibilities of this new bone replacement material. "The literature and my own research evaluations of medical grade calcium sulfate have shown that the material has osteoconductive properties," said Steven Gitelis, M.D., Associate Chairman, Department of Orthopaedics, Rush Medical College. "This means that this material allows or encourages cells to generate bone in and on its surfaces, thus furthering the effectiveness of this material as a bone void filler."

Donald Speer, M.D., Professor of Surgery and Anatomy, University of Arizona Health Sciences Center says, "This is such an amazing product with such good results. Another benefit is that the pellets can be seen on the x-ray and become their own radiographic marker to follow the course of resorption and replacement of the graft by new bone. You can actually see from week to week the formation of new healthy bone."

Children are one of the patient groups that will greatly benefit from this product. Says Dr. Speer, "Because children do not have a lot of available bone stock, you may not be able to harvest enough bone from the child and may need to add a substitute. Medical grade calcium sulfate pellets are ideal for this purpose."

Patients who have bone infections will also benefit from OSTEOSET(TM)'s ability to be resorbed by the body. Other bone graft substitutes which remain in the body for an extended period may serve as agents or hosts to prolong the infection. Since there is no trace of the OSTEOSET(TM) pellets after 4 to 8 weeks, there is nothing on which the infectious agents may reside or bind.

OSTEOSET(TM) is Wright Medical Technology, Inc.'s first entry into the bone graft market, which is approaching one half billion dollars annually. The company plans to offer other biological skeletal repair products in the near future. OSTEOSET(TM) is currently offered in an "off the shelf" sterile pellet form. Other configurations are currently under development at Wright Medical Technology, Inc. and should soon be available to the market.

Wright Medical Technology, Inc. is an ISO 9000 certified designer, manufacturer and worldwide distributor of orthopaedic products and instrumentation.

CONTACT: Wright Medical Technology, Inc., Arlington

Rebecca Ensley, 901/867-4305