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Smith & Nephew Bone Healing Device Awaits U.K. Approval

The U.K.’s health-cost regulator is seeking more information about Smith & Nephew Plc’s Exogen bone-healing device before recommending its use by the National Health Service for short-term fractures.

The National Institute for Health and Clinical Excellence is opening consultation proceedings on Exogen, a device that treats bone fractures by emitting ultrasound waves, after evidence of the technology’s ability to repair unhealed shorter-term breaks proved inconclusive, the London-based regulator said today. The authority issued draft guidance for the use of Exogen on fractures that have failed to heal after nine months.

Exogen, which saves 1,164 pounds ($1,830) per patient to treat nine-month-old fractures without surgery, is less cost effective when the treatment is used on breaks that haven’t lasted as long, NICE said. The device’s cost increase versus traditional treatments on three-month-old fractures amounts to 504 pounds per patient, NICE estimated.

There are “uncertainties about the rate at which healing progresses and whether surgery would otherwise be needed,” Carole Longson, director of NICE’s Center for Health Technology Evaluation, said in the statement. “The cost modeling was therefore complex, and the case for routine adoption in the NHS could not be convincingly made.”

Exogen Product

Smith & Nephew, Europe’s largest maker of artificial hips and knees, gets three-quarters of revenue from advanced surgical devices in areas such as orthopedics. The London-based manufacturer acquired the U.S. company that makes the Exogen device in 1999. The product is now part of a joint venture that Smith & Nephew set up with Palo Alto, California-based venture-capital firm Essex Woodlands Health Ventures earlier this year.

“The public consultation will allow patients, patient support groups and health-care professionals to help define the appropriate use of Exogen so that these patients can get the best treatment while significant savings are made for the NHS,” said John Everett, vice-president of Smith & Nephew’s commercial operations, in an e-mailed statement.

The Exogen system is designed to save on surgical and hospital costs by being used by patients at home in 20-minute treatment sessions, according to NICE. The device stimulates healing by promoting new bone production. The ultrasound devices for nine-month and three-month fractures are priced at 2,562.50 pounds and 999.38 pounds respectively.

NICE provides recommendations on cost effectiveness for treatments used by the state-run NHS as the basis for deciding whether to pay for a drug or health-care equipment.

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