FDA Approves Marketing of Exogen Ultrasound Device

Smith & Nephew Plc 23 February 2000 SMITH & NEPHEW RECEIVES FDA APPROVAL FOR MARKETING THE EXOGEN ULTRASOUND DEVICE FOR NON-HEALING FRACTURES Memphis, Tennessee - February 23, 2000 -- Smith & Nephew Orthopaedics announced today that it has received pre-market approval (PMA) from the U. S. Food and Drug Administration (FDA) to market its Exogen 2000, a non-invasive ultrasound fracture therapy for the treatment of established non-union bone fractures. A non-union is considered to be established when the fracture site shows no visible signs of healing. The clinical studies for the PMA resulted in an 86 percent healed rate for challenging non-union fractures that had failed to heal after prior orthopaedic treatment. In 1994, the FDA approved the Exogen device for marketing as the only commercially available treatment for the acceleration of fresh fracture healing. With this expanded approval, the Exogen therapy becomes the only bone stimulation treatment indicated for both fresh and non-union fractures. Currently, in the United States the Exogen therapy has been prescribed for over 18,000 patients by more than 7,000 physicians and has been approved for payment by over 800 third party payers. The therapy is also available in an additional 17 countries. Larry Papasan, President of Smith & Nephew Orthopaedics stated, 'Receiving FDA approval of this product is a significant milestone. Smith & Nephew is now the only company to be able to offer ultrasound therapy for both fresh and non-union fracture treatment. More importantly, the availability of the Exogen 2000 therapy offers patients with hard-to-heal fractures a clinically proven treatment that will help them recover much faster. The Exogen product line and this expanded approval positions Smith & Nephew as a formidable competitor in this $140 million bone stimulation market.' He further stated, 'We have a U.S. Sales network to over 300 representatives and intend to utilize our worldwide marketing resources to ensure that patients around the world benefit from this proven therapy.' Patrick A. McBrayer, President of Exogen stated, 'We are pleased that our diligent efforts to build a worldwide presence in ultrasound fracture healing has now been greatly enhanced by this approval. This action by the FDA reinforces the reputation of Exogen's ultrasound therapy as a reliable addition to the orthopaedic management of fresh and now non-union fractures. We expect this action may serve to make this cost-effective therapy more widely available to patients and their physicians.' A Smith & Nephew company, Exogen designs, develops, manufactures and markets medical devices for the non-invasive treatment of musculoskeletal injury and disease. Exogen's proprietary ultrasound and mechanical stress technologies are based on the well-established principle that bone growth is stimulated by mechanical force. Smith & Nephew is a global medical device company that develops, manufactures and markets a wide range of clinically advanced tissue repair products, primarily in the areas of orthopaedics, endoscopy and wound management. In particular, the company focuses on innovative technology that will benefit the healthcare system by improving patient care, reducing healthcare costs, and educating and training healthcare professionals. Enquiries: Chris O'Donnell, Chief Executive Tel: +44 (0) 207 401 7646 Smith & Nephew plc Fax: +44 (0) 207 930 3418 Peter Hooley, Finance Director Tel: +44 (0) 207 401 7646 Smith & Nephew plc Fax: +44 (0) 207 930 3426 David Yates/Sophie Pender-Cudlip Tel: +44 (0) 207 831 3113 Financial Dynamics Fax: +44 (0) 207 831 6341
UK 100

Latest directors dealings