SBi's STAR™ TOTAL ANKLE REPLACEMENT COVERED IN WASHINGTON STATE, OREGON AND ALASKA BY LIFEWISE HEALTH PLANS
NEW YORK, NY: April 18, 2011 – Small Bone Innovations, Inc. (SBi) announced today that LifeWise health plans in Washington State, Oregon and Alaska, covering 1.6 million members, have revised their coverage policies to cover the company's STAR™ total ankle. The STAR ankle is the only total ankle replacement system (TAR) cleared through the U.S. Food and Drug Administration's (FDA) rigorous pre-market approval process (PMA).
LifeWise offers plans under the brand name Premera Blue Cross in Alaska and Washington State, as well as its LifeWise Health Plans of Oregon and LifeWise Health Plans of Washington.
LifeWise's policy changes extend STAR ankle coverage to more than 92 percent or 161 million privately insured health plan members in the U.S. This includes major private insurers such as all BlueCross and BlueShield Association member companies, Aetna, Cigna, Coventry and others. Almost all of the 100 million eligible individuals covered by governmental insurance programs such as Medicare, Medicaid and TRICARE also have access to the STAR ankle, as well as most individuals covered by state workers' compensation programs. This brings the total covered lives for TAR in the U.S. to 261 million.
The STAR ankle's safety and effectiveness was compared with ankle fusion in a multi-center, multi-year, Investigational Device Exemption (IDE) study. The study results, published in 2009, supported the only PMA order to be issued by the FDA for a total ankle joint replacement by demonstrating the STAR to be superior in efficacy and comparable in safety to fusion.
Dr. Jeffrey Christensen¹, a Seattle-based Podiatric Foot & Ankle Surgeon said: "The latest generation of TAR systems are providing a high level of functionality as well as eliminating or minimizing pain – leading to longer term benefits that patients, as well as insurers, can recognize. Should these early surgical benefits last up to ten years or more, which STAR has demonstrated, we could see total ankle technology replacing fusion as the gold standard for treating mid-to-late stage ankle arthritis."
¹ Dr. Christensen is 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.