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Blackstone Medical Inc. Signs New Production Agreement With Regeneration Technologies Inc. (RTIX)



12/26/2006 11:33:45 AM

HUNTERSVILLE, N.C.--(BUSINESS WIRE)--Orthofix International N.V. (NASDAQ: OFIX) announced today that Blackstone Medical, Inc. (Blackstone), its recently acquired spine implant and biologic subsidiary, has signed an agreement with Regeneration Technologies, Inc. (RTI) (Nasdaq: RTIX) to manufacture spinal allograft implants designed by Blackstone.

RTI’s proprietary BioCleanse® process has helped make them an industry leader in the manufacturing of orthopedic, cardiovascular and other biologic implants, as well as the only FDA-approved producer of sterilized allograft products.

Matt Lyons, Blackstone’s chief executive officer, stated, “This partnership provides us with a competitive advantage in an industry where allograft implants are continuously scrutinized by surgeons and the FDA to ensure the absence of contamination. The agreement gives us not only additional capacity to provide our recently expanded portfolio of allograft implants to our physician customers, but with RTI’s patented BioCleanse process we gain an additional measure of confidence in our abilities to continue to provide high-quality products to the marketplace.”

Brian K. Hutchison, RTI's chairman, president and chief executive officer, added, "We are very excited to have the opportunity to work with Blackstone, which is highly regarded for its well engineered and innovative product designs. This agreement gives both companies the opportunity to further enhance the quality of biologic alternatives available to physicians and patients."

In addition to several recent product launches, new allograft implant designs are currently being developed by Blackstone’s engineers. The next allograft product launch is scheduled for April 2007, with additional launches planned during the second half of 2007.

About Orthofix International, N.V.

Orthofix International N.V., a global diversified orthopedic products company, offers a broad line of minimally invasive surgical, as well as non-surgical, products for the spine, reconstruction, and trauma market sectors that address the lifelong bone-and-joint health needs of patients of all ages, helping them achieve a more active and mobile lifestyle. Orthofix’s products are widely distributed around the world to orthopedic surgeons and patients via Orthofix’s sales representatives and its subsidiaries, including Breg, Inc. and Blackstone Medical, Inc., and via partnerships with other leading orthopedic product companies, including Kendall Healthcare. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Orthopedic Research and Education Foundation, Rutgers University, the Cleveland Clinic Foundation, and National Osteoporosis Institute. For more information about Orthofix, please visit www.orthofix.com.

About Blackstone Medical, Inc.

Blackstone Medical, Inc., established in 1996, is a leading international spine product company dedicated to advancing techniques and technologies in the treatment of the human spine. Partnering with luminary spine surgeons to identify solutions and using a quality team approach with engineers, Blackstone creates breakthrough spinal implant and instrument products. Blackstone's achievement-driven focus results in rapid design, cooperative manufacturing and exceptional service to surgeons. For more information about Blackstone Medical, Inc., please visit www.blackstonemedical.com

Forward-Looking Statements

This news release contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but are not limited to, statements concerning expectations associated with the development and distribution of new products involving Orthofix and its subsidiaries, and are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. Factors that could cause or contribute to such differences may include, but are not limited to, unanticipated delays in product development, changing relationships with customers, suppliers and strategic partners, risks relating to the protection of intellectual property, changes to the reimbursement policies of third parties, changes to governmental regulation of medical devices, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the orthopedic industry and the economy and other factors described in the most recent report on Form 10-K and other periodic reports filed by Orthofix with the Securities and Exchange Commission.

Orthofix International N.V. Dan Yarbrough, Director of Investor Relations, 704-948-2617


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