STAR™ Total Ankle Replacement Being Covered in Arkansas by QualChoice Health Plans
NEW YORK--(BUSINESS WIRE)--: June 14, 2011 – Small Bone Innovations, Inc. (SBi) announced today that effective March 8, 2011, health plans managed by QualChoice Health Plans, Little Rock, AK, covering almost 50,000 members in Arkansas, will reimburse SBi's STAR™ total ankle replacement system. QualChoice offers a comprehensive line of health benefits and ancillary products on both a fully insured and self-insured basis.
The decision by QualChoice, the second largest health insurer in Arkansas, means that the procedure is now accessible by 95 percent or more than 260 million Americans enrolled in either private or government-funded health plans such as Medicare.
Since SBi's reimbursement consultant, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), launched a program in 2009 to communicate clinically proven benefits, comparative effectiveness and overall cost benefits of the STAR ankle, virtually all insurers have revised their policies to provide coverage for total ankle replacement.
The STAR ankle is the only total ankle replacement system ever to be cleared through the U.S. Food and Drug Administration's (FDA) rigorous Premarket Approval (PMA) process. In the PMA process, the STAR ankle's safety and effectiveness was compared with ankle fusion in a multi-center, multi-year, Investigational Device Exemption (IDE) study. The STAR was found to be superior in efficacy and comparable in safety to fusion.
The IDE and other study results also demonstrated that the STAR ankle has better pain relief, greater clinical success, less blood loss and a shorter operating time than fusion – offering the prospect of a new standard of care to patients and their physicians.
A prominent reconstructive foot and ankle surgeon in Little Rock, Jesse B. Burks, DPM, said: "For years the only option for people with severe ankle arthritis was fusion. Nobody likes the idea of having a stiff ankle. The big thing with the STAR ankle is its ability to actually mimic the anatomical function of a good ankle joint resulting in a real step forward in treating this painful condition."
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, 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.