British orthopedic devices maker Smith & Nephew (FTSE:SN, NYSE:SNN) will need to provide more information on its Exogen bone-healing system before getting the green light for use in all fractures, U.K. regulators said.
The National Institute for Health & Clinical Excellence issued draft guidance on use of Exogen in treating long bone fractures that have not healed through standard treatment after 9 months, holding opinions on shorter-term fractures.
The Exogen system delivers low-intensity pulsed ultrasound waves to stimulate bone healing, used in 20-minute daily doses self-administered at home by the patient. The device has no known side effects or contra-indications, according to Smith & Nephew.
The technology previously won positive NICE guidance in December 2010, when the agency advised that Exogen was a safe and effective treatment for reducing healing time for patients with fractures that failed to heal on their own, according to a press release.
The new guidance proposal aims to reconsider the technology in terms of its cost-effectiveness when compared with surgical intervention, calling for more information on the device’s efficacy in newer breaks.
"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," Smith & Nephew biologics commercial operations vice president John Everett sad in prepared remarks. "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."
The U.K. regulatory agency’s External Assessment Centre evaluated the benefits of Exogen treatment, estimating that the technology could save about $1,828 (£1164) per patient when compared with surgery for non-union of a fracture still unhealed after 9 months, according to guidance documents.
That’s a lower cost-savings measure than in Smith & Nephew’s calculations, but the agency maintained that Exogen therapy is a significantly cheaper option.
For 3-month-old fractures the agency estimated cost savings of about $791 (£504) per patient, but asked for more information before issuing guidance.
The agency asked Smith & Nephew to provide additional data regarding bone healing rates used in the company’s evaluations, finding that there wasn’t enough information to determine whether Exogen was appropriate for shorter-term breaks.