EXOGEN(TM) Bone Healing System Receives Expanded Medicare Coverage
Apr 30, 2005 - 9:01:00 AM
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"This decision opens up more options for patients and surgeons, providing a non-invasive alternative to surgical treatment, and offering an opportunity for people to regain their mobility. We have worked closely with CMS, providing data from clinical studies and other scientific data that consistently demonstrated similar healing rates in patients with and without previous surgery, as well as economic analyses that highlighted the cost-effectiveness of EXOGEN(TM)."
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By Smith & Nephew, Inc.,
[RxPG] Smith & Nephew Orthopaedics (NYSE: SNN - News; LSE: SN - News) today announced that the United States Centers for Medicare & Medicaid Services (CMS) has expanded existing Medicare coverage of its EXOGEN(TM) Bone Healing System for the treatment of all nonunion bone fractures, regardless of whether the fracture has had prior surgical intervention.
The EXOGEN(TM) Bone Healing system delivers low-intensity pulsed ultrasound to a fracture site, and is the only ultrasound stimulation device approved by the FDA for the treatment of nonunion fractures. In addition, the EXOGEN(TM) system is the only osteogenic bone stimulator of any kind approved by the FDA for accelerating the healing of indicated fresh fractures*.
Medicare has reimbursed the cost of using the EXOGEN(TM) device since 2000 in nonunion fracture cases where surgery has failed to heal a fracture. Medicare will now offer reimbursement for the use of the EXOGEN(TM) system for all nonunions, regardless of whether they have had prior surgical intervention.
"This decision opens up more options for patients and surgeons, providing a non-invasive alternative to surgical treatment, and offering an opportunity for people to regain their mobility," said Joe Woody, vice president and general manager of the Clinical Therapies division of Smith & Nephew. "We have worked closely with CMS, providing data from clinical studies and other scientific data that consistently demonstrated similar healing rates in patients with and without previous surgery, as well as economic analyses that highlighted the cost-effectiveness of EXOGEN(TM)."
Nonunions are defined clinically as the point when bone healing has stopped and will not proceed without some type of intervention. Three studies conducted on nonunions demonstrated that use of the EXOGEN(TM) Bone Healing System for 20 minutes per day, with no other change in treatment, was highly successful for all bones, all fracture locations, and all types of fracture irrespective of the type of orthopaedic fracture management.
CMS' decision was in response to Smith & Nephew's request that the requirement for failed prior surgical intervention to qualify for reimbursement be removed. Data presented and reviewed by CMS included:
- Newly published scientific data on the EXOGEN(TM) unit mode of action, which indicates that EXOGEN(TM) affects a range of cells important to the fracture healing process.
- Published economic analysis(1) which concludes, based on the high success rates in the clinical studies, that the EXOGEN(TM) system is the most cost-effective bone stimulator for the treatment of nonunion fractures.
In coming to a decision to expand nonunion coverage for the EXOGEN(TM) Bone Healing System, CMS reviewed the science, assessed the overwhelmingly positive public comment from physicians and patients, and conducted their own pooled analysis of the clinical data -- which showed an 85% success rate with the EXOGEN(TM) unit regardless of whether there had been prior surgery or not.
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Additional information about the news article
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The complete coverage decision may be accessed at: www.cms.hhs.gov/coverage/DM042605.pdf
(1) "Cost-Effectiveness of Bone Stimulators in the Conservative Treatment of Stable Nonunion Fractures" by M Oremus (Pharmaccess, Inc. Montreal Canada), M Schultz (Pharmaccess, Inc. Montreal Canada), CS Whitman (Hugh Chatham Memorial Hospital, Elkin, NC, USA), JD Conway (Sinai Hospital of Baltimore, Baltimore, MD, USA)
*The indicated fresh fractures include fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade 1 open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization.
Clinical Therapies
Smith & Nephew Orthopaedics' Clinical Therapies, which markets the EXOGEN(TM) Bone Healing System and SUPARTZ(TM) joint fluid therapy, is a business division within Orthopaedics. The Clinical Therapies business has grown considerably, 50% in the U.S. and 44% globally in 2004.
About Smith & Nephew
Smith & Nephew (NYSE: SNN, LSE: SN) ( www.smith-nephew.com ) is a global medical technology business, specializing in Endoscopy, Orthopaedics and Advanced Wound Management products. Smith & Nephew ranks as the global leader in arthroscopy and one of the world's leaders in advanced wound management and is one of the fastest growing orthopaedics companies in the world.
Smith & Nephew is dedicated to helping improve people's lives. The company prides itself on the strength of its relationships with its surgeon and professional healthcare customers, with whom its name is synonymous with the highest standards of performance, innovation and trust. The company has more than 8,000 employees and operates in 32 countries around the world and generated sales of nearly $2.3 billion.
Forward-Looking Statements
This press release contains certain "forward-looking statements" within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In particular, statements regarding planned growth in our business and in our operating margins discussed under "Outlook" are forward-looking statements as are discussions of our product pipeline. These statements, as well as the phrases "aim," "plan," "intend," "anticipate," "well-placed," "believe," "estimate," "expect," "target," "consider" and similar expressions, are generally intended to identify forward-looking statements. Such forward- looking statements involve known and unknown risks, uncertainties and other important factors (including, but not limited to, the outcome of litigation and regulatory approvals) that could cause the actual results, performance or achievements of Smith & Nephew, or industry results, to differ materially from any future results, performance or achievements expressed or implied by such forward-looking statements. 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 20F, for a discussion of certain of these factors.
All forward-looking statements in this press release are based on information available to Smith & Nephew as of the date hereof. All written or oral forward-looking statements attributable to Smith & Nephew or any person acting on behalf of Smith & Nephew are expressly qualified in their entirety by the foregoing. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement contained herein to reflect any change in Smith & Nephew's expectation with regard thereto or any change in events, conditions or circumstances on which any such statement is based.
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