Smith & Nephew (LSE: SN, NYSE: SNN), the global medical technology business, today announces that the National Institute for Health and Clinical Excellence (NICE) has issued draft guidance supporting the case for utilising the EXOGEN◊ Ultrasound Bone Healing System. NICE has opened a consultation period regarding its draft findings and encourages public comments on the use of EXOGEN to treat long bone fractures that have either shown a delay in healing or have been clinically assessed as a non-union, meaning the bone has not healed nine months after the fracture occurred. 1
EXOGEN's technology previously received positive NICE guidance in December 2010 when the organisation 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“The publication of draft guidance on the use of EXOGEN in the routine treatment of long bone fractures with impaired healing is an important step in a process which has seen close collaboration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, Smith & Nephew's VP 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.” Manufactured by Bioventus LLC and distributed outside the United States by Smith & Nephew, EXOGEN is indicated in Europe to accelerate the healing of recent fractures and to heal bones that have either delayed healing or that simply have failed to heal (non-unions). EXOGEN has been shown to heal 86 per cent of non-union fractures 2 and accelerate the healing of fresh fractures up to 38 per cent faster than normal. 3,4
EXOGEN is a portable, lightweight device that delivers the prescribed treatment in a convenient 20-minute daily regimen, self-administered at home by the patient. A digital display guides patients step-by-step through proper operation and the main unit monitors treatment - providing the clinician with an accurate record for reference.
EXOGEN is globally recognised as a safe treatment with no contra-indications or known side effects and is supported by robust and significant clinical data.
Enquiries
| Media - Corporate | |
| Charles Reynolds | +44 (0) 20 7401 7646 |
| Smith & Nephew | |
| Media - Product | |
| Michael Vinegrad | +44 (0)1904 824135 |
| Smith & Nephew | michael.vinegrad@smith-nephew.com |
About Smith & Nephew
Smith & Nephew is a global medical technology business dedicated to helping improve people's lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma, Smith & Nephew has almost 11,000 employees and a presence in more than 90 countries. Annual sales in 2011 were nearly $4.3 billion. Smith & Nephew is a member of the FTSE100 (LSE: SN, NYSE: SNN).
About Bioventus LLC
Bioventus is a global leader of active orthopaedic healing, providing clinically proven and cost-effective therapies and diagnostics that help patients regain active lifestyles. The company's innovative products include the market-leading bone stimulation device and osteoarthritis joint fluid therapies. Bioventus' adherence to high quality standards, its commitment to evidence-based medicine and its strong ethical behavior makes it a trusted partner for physicians worldwide.
For more information, visit www.BioventusGlobal.com or follow the company on Facebook (www.facebook.com/bioventus) or Twitter (@BioventusGlobal or www.twitter.com/BioventusGlobal).
EXOGEN is a registered trademark of Bioventus LLC.
Forward-looking Statements
This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as "aim", "plan", "intend", "anticipate", "well-placed", "believe", "estimate", "expect", "target", "consider" and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payors and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; strategic actions, including acquisitions and dispositions, our success in integrating acquired businesses, and disruption that may result from changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business or competitive nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew's most recent annual report on Form 20-F, for a discussion of certain of these factors.
Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew's expectations.
◊ Trademark of Smith & Nephew. Certain marks registered US Patent and Trademark Office.
References
- The draft medical technologies guidance, “EXOGEN ultrasound bone healing system for long bone fractures with non-union or delayed healing”, is available at http://guidance.nice.org.uk/MT/154
- Nolte et al (2001) Low Intensity Pulsed Ultrasound in the Treatment of Nonunions, J. Trauma 51 (4) 693-703
- Kristiansen et al (1997) J. Bone Joint Surg. 79A 961-973 Accelerated Healing of Distal Radial Fractures with the Use of Specific, Low-Intensity UltrasoundA Multicenter, Prospective, Randomized, Double- Blind, Placebo-Controlled Study
- Heckman JD, Ryaby JP, McCabe J et al. (1994) Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. Journal of Bone & Joint Surgery - American Volume 76:26-34.
Indication Statements In the EU EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) including: Treatment of delayed union and non-unions, accelerating the time to heal of fresh fractures, treatment of stress fractures, accelerating repair following osteotomy, accelerating repair in bone transport procedures, accelerating repair in distraction osteogenesis procedures and treatment of joint fusion.
There are no known contraindications for the EXOGEN device. Safety and effectiveness has not been established for individuals lacking skeletal maturity; pregnant or nursing women; patients with cardiac pacemakers; on fractures due to bone cancer; or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel. Full prescribing information can be found at www.healmybone.com or by calling 0845 272 5957.