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
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