INSERTING and REPLACING CIGNA Revises Its Coverage Policy to Cover SBi’s STAR™ Ankle Replacement System Based on Review of Latest Clinical Data and Patient Experience

NEW YORK–(BUSINESS WIRE)–Insert in sixth graph, first sentence of release: Keith L. Wapner, MD, President of the American Orthopaedic Foot & Ankle Society, Professor…

“An increasing number of carefully selected patients seeking pain relief and restoration of movement in the ankle can benefit from this procedure by enjoying a better quality of life. The STAR ankle, the leading TAR system, will help drive this transformation”

The corrected release reads:

CIGNA REVISES ITS COVERAGE POLICY TO COVER SBI’S STAR™ ANKLE REPLACEMENT SYSTEM BASED ON REVIEW OF LATEST CLINICAL DATA AND PATIENT EXPERIENCE

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 CIGNA, one of the nation’s leading healthcare insurers, has revised its coverage policy to cover Total Ankle Replacement (TAR) using FDA-approved devices.

CIGNA’s healthcare network includes 612,000 primary care doctors and specialists, 5,400 hospitals and comprises more than 11 million U.S. members. CIGNA’s positive decision on TAR coverage further increases the number of individuals in commercial plans with access to TAR by 6%, according to SBi’s reimbursement consultant, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA). This increase follows the positive decision by Aetna earlier this month, and raises the total number of individuals in commercial plans with access to TAR by 17%.

In its medical coverage policy recommendation issued today, CIGNA indicated that it will cover TAR “for a skeletally mature individual as medically necessary for the treatment of severe inflammatory arthritis (e.g. rheumatoid arthritis), severe osteoarthritis, or post-traumatic arthritis of the ankle, as an alternative to ankle arthrodesis (or fusion).” The policy goes on to list various diagnostic criteria that must be met before approving any TAR procedure.

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

Charles Schneider, Vice President of Health Economics, Reimbursement and Public Policy at MCRA, said: “The major U.S. commercial carriers, such as CIGNA today and many others previously, have modified their coverage policies to support patient access to TAR procedures. Insurers have determined that implants such as the STAR ankle are safe, effective and offer a clinically proven treatment option for patients suffering from end-stage ankle arthritis. The STAR ankle in particular has demonstrated superior effectiveness and comparable safety to ankle fusion in a U.S. prospective, multi-center IDE clinical trial. Also, long term results from some of the 17,000 STAR recipients worldwide underline the implant’s performance from a cost-of-care perspective,” Mr. Schneider added.

Keith L. Wapner, MD, President of the American Orthopaedic Foot & Ankle Society, Professor of Orthopedic Surgery and Director of the Foot & Ankle Fellowship Program at the University of Pennsylvania, said: “The current total ankle designs, like the STAR, give surgeons a better range of options for treating the most severe forms of ankle arthritis with the object of providing better results in terms of motion preservation than fusion. It is entirely possible that we may be able to duplicate the success of hip and knee arthroplasty by establishing a new gold standard for treating this debilitating condition.”

Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “I am extremely pleased with CIGNA’s revised coverage policy for TAR which follows Aetna’s recent positive decision on TAR. The growing acceptance of the STAR ankle among health insurers, combined with surgeon response to our training programs, suggests that TAR will become the new gold standard for the treatment of moderate to severe ankle arthritis.

“An increasing number of carefully selected patients seeking pain relief and restoration of movement in the ankle can benefit from this procedure by enjoying a better quality of life. The STAR ankle, the leading TAR system, will help drive this transformation,” Mr. Viscogliosi added.

About Small Bone Innovations, Inc.

Small Bone Innovations, Inc. (SBi), founded in 2004 by Viscogliosi Brothers, LLC, (VB), the New York-based merchant banking firm specializing in musculoskeletal/orthopedics, is 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. SBi has facilities in New York; Morrisville, PA; Bourg-en-Bresse, France; Donaueschingen, Germany and Kuala Lumpur, Malaysia.

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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