Healthcare Industry News:  allograft 

Devices Regenerative Medicine Orthopaedic

 News Release - May 5, 2009

Orthofix International Announces Limited Market Release of Trinity Evolution and Completion of First Surgical Procedure Using New Stem Cell-Based Allograft

BOSTON--(HSMN NewsFeed)--Orthofix International N.V. (NASDAQ: OFIX ) (the Company) announced today that the Company has begun the limited market release of Trinity® Evolution™ in collaboration with the Musculoskeletal Transplant Foundation (MTF). Trinity Evolution is a stem cell-based bone growth matrix designed to advance the surgical use of allografts by providing characteristics similar to an autograft in spinal and orthopedic procedures.

“We are extremely pleased to announce that we have begun to make Trinity Evolution available to our surgeon customers. The initial feedback we have received on Trinity Evolution has been extraordinarily positive, and we look forward to our full market release by July 1, 2009,” said Alan Milinazzo, President and CEO of Orthofix International.

Dr. Steve Yocom completed the first procedure using Trinity Evolution on April 28th. The 46-year-old patient underwent a lumbar spine fusion procedure at Cooper University Hospital in Camden, NJ. Since commencing our limited release, Trinity Evolution has been implanted in a variety of spinal and orthopedic procedures by several leading surgeons around the country, including Dr. Michael Zindrick, Dr. Mark Lorenz, Dr. Christopher Bibbo, Dr. Daniel Lee and Dr. Jamie Gottlieb.

“Trinity Evolution is an excellent new tissue form that should be of great benefit to patients and the doctors who serve them,” said Bruce Stroever, President and CEO of MTF.

Trinity Evolution is used by surgeons to facilitate bone fusion, and will be marketed exclusively by Orthofix Spinal Implants and Orthofix Orthopedics. MTF is responsible for the recovery of donor tissue, the processing of the bone growth matrix, and for the fulfilment of orders received.

Orthofix anticipates completing the full market release of Trinity Evolution by July 1st of this year.

About Orthofix

Orthofix International, N.V., a global medical device company, offers a broad line of minimally invasive surgical, and non-surgical, products for the spine, orthopedic, and sports medicine 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. In addition, Orthofix is collaborating in R&D partnerships with leading medical institutions such as the Musculoskeletal Transplant Foundation, the Orthopedic Research and Education Foundation, Rutgers University, Texas Scottish Rite Hospital for Children and National Osteoporosis Institute. For more information about Orthofix, please visit

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of 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, risks relating to the expected sales of its products, including recently launched products, unanticipated expenditures, 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 and interpretation of 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, corporate development and market development activities, including acquisitions or divestitures, unexpected costs or operating unit performance related to recent acquisitions and other factors described in our annual report on Form 10-K and other periodic reports filed by the Company with the Securities and Exchange Commission.

Source: Orthofix International

Issuer of this News Release is solely responsible for its content.
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