NEW YORK – April 14, 2011 – Small Bone Innovations, Inc. (SBi) announced today that nearly 1.3 million individuals in the state of Arizona covered by BlueCross BlueShield (BCBS) of Arizona, the state's largest health insurance company, will have access to SBi's STAR™ Total Ankle Replacement system following a revision of its coverage policy.
All 39 independent member companies of the BlueCross and BlueShield Association now cover SBi's STAR™ Total Ankle Replacement system to benefit an estimated 98 million members or one-in-three Americans. With the policy revision by BCBS of Arizona, total patient access to the STAR ankle has risen to approximately 92 percent or 161 million of privately insured patients in the U.S.
Almost all of the 100 million individuals eligible to be covered by governmental insurance programs such as Medicare, Medicaid and TRICARE also have access to the STAR ankle, as well as most of those covered by state workers' compensation programs.
STAR is the only total ankle replacement approved through the U.S. Food and Drug Administration's (FDA) rigorous pre-market approval (PMA) process. SBi is a privately-owned orthopedics company focused exclusively on treatments for joint replacement or arthroplasty and post-traumatic reconstruction of the small bones & joints of the thumb, fingers, hand, wrist, elbow, toes, foot and ankle.
Charles Schneider, Vice President of Health Economics, Reimbursement and Public Policy at Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), a consultant to SBi, said: "The policy changes by most insurers are in response to positive outcomes from the successful PMA clinical trials of the STAR ankle and the publication of extensive peer-reviewed clinical papers on long term studies of STAR patients."
The STAR ankle was compared to ankle fusion in a multi-center, multi-year, Investigational Device Exemption (IDE) study to assess the device's safety and effectiveness. The study results supported the only PMA order to be issued by the FDA for total ankle joint replacement. In the study, the STAR ankle was demonstrated to be superior in efficacy and comparable in safety to fusion – benefits that resonate with insurers as well as patients and their surgeons.
Eric P. Anctil MD, a prominent foot and ankle surgeon at the Tucson Orthopaedic Institute in Arizona, said: "In carefully selected patients, this current generation of ankle replacement technologies helps preserve natural joint motion and significantly reduce advanced arthritis pain. This approach can be an effective alternative to the traditional procedure of joint fusion."
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.