NEW YORK – March 10, 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 UniCare, a subsidiary of WellPoint Health Networks, Inc. (NYSE:WLP), the nation's leading commercial health care insurer with over 30 million members, has revised its coverage policy to cover Total Ankle Replacement (TAR) systems that are FDA-approved and cleared.
UniCare members access WellPoint's nationwide network of primary care doctors and treatment facilities serving 13 million members in 37 states. UniCare's positive decision on TAR coverage further increases the number of individuals in commercial plans with access to TAR by 7%, according to SBi's reimbursement consultant, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA). This increase follows the positive decision by Aetna and CIGNA announced last month, and raises the total number of individuals in commercial plans with access to TAR by 24%.
Charles Schneider, Vice President of Health Economics, Reimbursement and Public Policy at MCRA, said: "The majority of the largest U.S. commercial carriers, such as Aetna, CIGNA and UniCare, have now modified or revised their coverage policies to support patient access to TAR procedures having determined that solutions 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.
James K. DeOrio¹, MD, an orthopedic surgeon and Associate Professor at the Duke School of Medicine, said: "The current crop of mobile-bearing total ankle designs, such as the STAR ankle, have evidenced less wear and loosening than earlier designs. These ankles exhibit reasonable functional outcomes as well as eliminating or minimizing pain – which accounts for the change in attitude among insurers. In fact, it is possible that TAR technology may succeed fusion as the gold standard for treating mid-to-late stage ankle arthritis."
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "We are witnessing a rapid turn of events among healthcare insurers in terms of covering TAR and I expect there to be universal coverage for the procedure within the next year or so, providing great relief and joy among the many thousands suffering from this debilitating and depressing condition.
"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.
¹ Dr. DeOrio is a paid consultant to SBi - providing education services.
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.
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.