Smith & Nephew Asked to Provide Data on Bone Healing System

The health authority of the National Health Service (NHS) in England, the National Institute for Health and Clinical Excellence (NICE), has issued draft guidance supporting the case for using Smith and Nephew plc’s (S&N’s) Exogen Ultrasound Bone Healing System for fractures older than nine months. The regulators still want more information regarding Exogen’s use in shorter-term fractures.

The Exogen system delivers ultrasound signals to accelerate bone healing. It is used for non-union fractures, (those that have not healed properly), and certain kinds of stress fractures. The system is portable and can be self-administered in 20 minutes at home by the patient, according to S&N. The system is marketed by S&N spin-off firm Bioventus LLC in the United States and certain other countries, but is still under the S&N umbrella in the United Kingdom pending regulatory proceedings.

The Exogen technology previously received positive NICE guidance in December 2010 when the organization advised healthcare professionals that the use of low-intensity pulsed ultrasound represents a safe and effective treatment option to reduce the healing time in patients with fractures. The new guidance builds upon these results by looking at the health economics of Exogen to determine potential benefits to patients and cost savings to the NHS compared with surgical intervention.

“The publication of draft guidance on the use of Exogen in the routine treatment of long bone fractures with impaired healing is an important step in a process which has seen close collaboration between Smith & Nephew and NICE,” said John Everett, S&N’s vice president of commercial operations for the biologics business. “There is strong evidence that Exogen has the potential to prevent significant numbers of patients with non-unions from requiring further complex surgery and consequently liberate valuable NHS resources. Additionally, there are known patient groups, such as those with diabetes and the elderly, who are at risk of not healing as might be expected due to their pre-existing conditions. The public consultation will allow patients, patient support groups and healthcare 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.”

NICE has requested further information on Exogen and its affect on the rate on bone healing from the company’s own evaluations.

Headquartered in Durham, N.C., Bioventus grew out of Smith & Nephew’s former Biologics and Clinical Therapies division. The company focuses on products to help accelerate bone healing and treat osteoarthritis pain.

Smith & Nephew is an orthopedic device manufacturer headquartered in London, United Kingdom.