ORTHOFIX GETS FDA APPROVAL FOR INVESTIGATION OF CERVICAL-STIM.

Orthofix International N.V. (Nasdaq: OFIX) has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration for the clinical investigation of the Orthofix Cervical-Stim, a non-invasive cervical bone growth stimulator. Based on the same technology as Orthofix's Spinal-Stim(R) product, the Cervical-Stim generates a pulsed, low-energy electromagnetic field (PEMF) to enhance the success rate of cervical fusions among high-risk patients, immediately after surgery.

This approval allows Orthofix to initiate a clinical evaluation of Cervical-Stim, which is the first step in obtaining Pre-Market Approval (PMA). Kevin T. Foley, MD, Associate Professor of Neurosurgery at the Semmes-Murphey Clinic and University of Tennessee, Memphis, will be the principal investigator for the clinical trial. The Cervical-Stim will enter evaluation in thirteen centers across the U.S. In the United States, it is estimated that more than 120,000 cervical fusions are performed each year.

The purpose of the clinical investigation is to evaluate the safety and efficacy of Cervical-Stim for increasing fusion rates among high-risk fusion patients. The two risk factors that have the greatest impact on the success rate of cervical fusions are smoking and multi-level fusion procedures. Review of the scientific literature indicates that the failure rate of cervical fusions is as high as 50% due to high risk factors such as smoking and multi-level fusion procedures.

Charles W. Federico, president of Orthofix, Inc. said, "We are looking forward to the beginning of patient enrollment in this important multi-center clinical trial. Cervical fusions are difficult in patients with one or more risk-factors that hamper healing. There are currently no other companies with an FDA approved indication for an adjunctive bone growth stimulation device for the cervical spine. Our Cervical-Stim is a solution to this growing unmet need."

The Cervical-Stim is a flexible, lightweight, comfortable device that is worn by the patient similar to a soft cervical collar, with padding in the back of the neck and supports a small battery driven microprocessor. Currently, Orthofix is the leader in the spinal stimulation market. PEMF revenues represented 41% of Orthofix's 1998 revenues. The current market for bone growth stimulators is over $200 million, growing at 14% per year.

Orthofix International N.V. is a leading provider of high-value, minimally invasive medical devices for the orthopaedic and trauma markets. After a 19-year history of successful innovation in the medical device field, Orthofix is well positioned to expand its focus and capitalize on the growing medical acceptance of high technology in orthopaedic treatment and spine repair. The company currently sells its diverse product line in 80 countries through three subsidiaries and distribution agreements with leading orthopaedic companies including Sulzer Medica, Sofamor Danek, a subsidiary of Medtronic Inc., Tyco Healthcare and B. Braun.

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