NOI GETS FDA CLEARANCE FOR TRIAL OF BONE GROWTH STIMULATOR.

Biotech Business, January, 2000

National Osteoporosis Institute (NOI) and Orthofix International N.V. (Nasdaq: OFIX) have announced that NOI has received clearance from the U.S. Food and Drug Administration to begin a clinical trial with Orthofix's Bone Growth Stimulator for the treatment of osteoporosis. As required by the FDA, the trial will evaluate the safety and efficacy of the Orthofix bone growth stimulator in osteoporotic patients, measuring improvements in bone mineral density.

The bone growth stimulator, developed by Orthofix Inc., utilizes a proprietary pulsed electro magnetic field ("PEMF") signal to treat patients with osteoporosis of the hips and/or spine. The stimulator is designed as a comfortable chair pad that the patient will sit on for several hours per day. Orthofix...

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