NEW YORK, NY : June 28, 2012 –Small Bone Innovations, Inc. (SBi) reported that Tufts Health Plan, covering approximately 936,000 members in Massachusetts and Rhode Island, is the first health plan in the nation to specify reimbursement for 'on-label' implantation of total ankle replacement (TAR) prostheses.

According to Tufts' current official policy document, "the (total ankle replacement) procedure is becoming the treatment of choice for patients, replacing the conventional use of arthrodesis, i.e. fusion of the bones. The relief of pain and restoration of range of motion is the key feature in favor of ankle replacement with respect to arthrodesis."

The policy document goes on to stipulate that any other ankle replacement device not approved by the US Food and Drug Administration (FDA), or implanted in a manner not approved by the FDA, will not be covered by Tufts.

STAR is the only total ankle replacement system approved for uncemented use through the FDA's rigorous Premarket Approval (PMA) process. All other total ankle replacement systems available in the US have only FDA 510(k) marketing clearance and must be implanted using bone cement. In the PMA process, the STAR ankle's safety and effectiveness was compared with ankle fusion in a prospective FDA- regulated, multi-center, multi-year, concurrently-controlled, Investigational Device Exemption (IDE) study. The IDE study results, published in 2009, demonstrated STAR to be superior in efficacy and comparable in safety to fusion.

The IDE and other subsequent studies show that the STAR ankle has better pain relief, greater clinical success, less blood loss and a shorter operating time than fusion. 

An independent survey by nVision Research, sponsored by SBi and supported by leading foot and ankle surgeons, James A. Nunley, MD and Michael J. Coughlin, MD, was conducted at the American Orthopaedic Foot & Ankle Society (AOFAS) conference in June 2008. According to the survey results, 97% of responding surgeons said they would choose an uncemented TAR implant given a choice between cemented and uncemented TAR implants. STAR is the only FDA-PMA approved ankle indicated for use without bone cement.

Anthony G. Viscogliosi, SBi's Founder & Executive Chairman, said: "The policies governing certain private health insurance plans and the guidelines used by state Workers Compensation Insurance programs, favor exclusive use of PMA-approved ankle replacements, thereby reducing the potential for 'off-label' approaches to implantation.

"This explains why the STAR ankle has quickly become the first choice among surgeons in appropriately diagnosed patients suffering from painful ankle osteoarthritis and rheumatoid arthritis," he added.

Roger A. Mann¹, MD, co-lead investigator in the IDE study and co-author of a recent long term study of STAR recipients, said: "I believe that the reason insurers are moving towards exclusively reimbursing PMA-approved total ankles is because of STAR's superior effectiveness when compared to fusion - along with most surgeons' preference for using the prosthesis without bone cement. In addition, my recent research documents 91% prosthesis survival at 9.1 years follow-up and 92% patient satisfaction - demonstrating STAR's long term durability and improvement in ankle function."

The STAR ankle is now available to 100% (about 175 million) of privately insured health plan members in the US and all 100 million eligible individuals covered by governmental insurance programs such as Medicare, Medicaid and TRICARE. Most individuals covered by state workers' compensation programs also have access to STAR.

¹Dr. Mann is a paid consultant to SBi.

About Small Bone Innovations, Inc.

Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC (VB), the New York-based merchant banking firm that specializes in the musculoskeletal/orthopedics sector. SBi was the first company to focus purely on small bones & joints by integrating established companies and professionals in the field. It offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in the small bones & joints. SBi has facilities in New York, NY, Morrisville, PA, Péronnas, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia and has sold its products in 41 countries.

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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