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AETNA ® REVISES ITS COVERAGE POLICY TO APPROVE SBi's STAR™ ANKLE REPLACEMENT SYSTEM AFTER REVIEWING CLINICAL DATA AND PATIENT EXPERIENCE

NEW YORK – February 11, 2011 – Small Bone Innovations, Inc. (SBi), an orthopedics company focused exclusively on serving patients and their physicians with technologies and treatments for joint repair (arthroplasty) and trauma reconstruction around the small bones & joints of the thumb, fingers, hand, wrist, elbow, toes, and foot & ankle, reported that Aetna, one of the nation's leading health care insurers, has revised its coverage policy to cover Total Ankle Replacement (TAR) using FDA-cleared or approved devices.

According to Aetna-reported data, its healthcare network comprises more than a million healthcare professionals; 561,000 primary care doctors and specialists; 5,300 hospitals and consists of 18.5 million members. Aetna’s positive decision on TAR coverage increases the number of individuals in commercial plans with access to TAR by 11% according to SBi’s reimbursement consultant, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA).

Following the introduction of STAR™ total ankle in the U.S. in June 2009, SBi engaged MCRA, a leading orthopedics consulting firm focused on clinical, regulatory, reimbursement, intellectual property, quality manufacturing, and healthcare services. MCRA presented the case for reimbursement of the STAR ankle to insurers and independent organizations that provide authoritative guidance on health care issues and practices. The firm provided insurers with information about TAR generally and specific evidence supporting the use of the STAR ankle in suitable patients.

Charles Schneider, Vice President of Health Economics, Reimbursement and Public Policy at MCRA, said: "The major U.S. commercial carriers, now including Aetna, and many others have modified their coverage policies to support patient access to TAR procedures.

“Having carefully evaluated the body of published outcomes, these carriers have determined that technologies such as the STAR ankle are safe, effective, and provide a durable solution for patients suffering from end-stage ankle arthritis. This is particularly true of the STAR ankle, which has demonstrated superior effectiveness compared to ankle fusion and safety results comparable to ankle fusion in a U.S. prospective, multi-centered IDE clinical trial. This is further supported by long-term results that have shown STAR to be effective both clinically and from a cost-of-care perspective,” Mr. Schneider added.

Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “Eminent orthopedic foot and ankle surgeons that conducted the STAR PMA IDE clinical trials are now part of a faculty educating surgeons by conducting laboratory workshops around the country. To date, more than 500 surgeons have been trained in the procedure in North America to provide broader access to the STAR ankle among patients with painful and debilitating conditions of moderate to severe ankle arthritis. It is estimated that as many as 70,000 patients annually require surgery to treat painful ankle arthritis.”

In addition to insurers, two medical societies representing foot & ankle surgeons, the American Orthopaedic Foot & Ankle Society (AOFAS) and American College of Foot and Ankle Surgeons (ACFAS) have each revised their position statements on ankle replacement and acknowledged TAR as an acceptable and viable alternative to fusion for carefully selected patients with ankle arthritis.

The AOFAS and ACFAS position statements can be referenced at: www.aofas.org/userfiles/file/PatientEd/TAR_0809.pdf www.acfas.org/Physicians/Content.aspx?id=1933 Mr. Viscogliosi noted: “Apart from demonstrating the clinical effectiveness of the STAR ankle, widespread adoption of the technology depends on reimbursement of the procedure. Ankle arthroplasty is not new – the STAR ankle alone has been implanted in more than 17,000 patients worldwide. The growing acceptance of the STAR ankle among health insurers since its U.S. introduction in 2009, combined with the surgeon response to our STAR training programs, suggests that total ankle replacement will become the new gold standard for treating a debilitating condition.”

About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC (VB), a New York-based merchant banking firm that specializes in the musculoskeletal/orthopedics sector. VB created SBi as the first company to focus purely on small bones & joints. By integrating established companies and professionals in the field, SBi offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in small bones & joints. Today, SBi has facilities in New York, NY, Morrisville, PA, Bourg-en-Bresse, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia and has sold its products in 46 countries.

For more information, please visit: www.totalsmallbone.com

Forward-looking statements
This news release contains forward-looking statements as defined in the U.S. Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of risks and uncertainties impacting SBi's business including increased competition; the ability of SBi to expand its operations and to attract and retain qualified professionals; technological obsolescence; general economic conditions; and other risks.

 

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