Health Net Plan Members Gain Access to STAR™ Total Ankle Replacement System
NEW YORK, NY (BUSINESS WIRE): May 25, 2011 –Small Bone Innovations, Inc. (SBi) announced today that approximately 1.4 million members of health insurance plans sponsored by Health Net in the Northeast tri-state region, Arizona, California, Georgia and Washington states now have access, retroactive to March, 2011, to SBi's STAR™ Total Ankle Replacement system.
The STAR ankle is the only total ankle replacement system cleared through the U.S. Food and Drug Administration's (FDA) rigorous Premarket Approval (PMA) process.
Health Net's policy change extends STAR ankle coverage to more than 94 percent or 164 million of all privately insured health plan members in the U.S. This includes major private insurers such as all Blue Cross and Blue Shield Association member companies, Aetna, Cigna, Coventry, LifeWise, Tufts, UniCare and others.
Almost all of the 100 million eligible individuals covered by governmental insurance programs, such as Medicare, Medicaid and TRICARE, also provide access to the STAR ankle, as well as most individuals covered by state workers' compensation programs.
Since SBi's reimbursement consultant, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), launched a program in late 2009 to communicate clinically proven benefits, comparative effectiveness and overall cost benefits of the STAR ankle, most insurers have revised their policies to provide coverage for an aggregate total of approximately 264 million insured lives.
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 study results, published in 2009, supported the only PMA approval order ever 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. 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.
Jerome K. Steck¹, DPM at Southern Arizona Orthopedics, Tucson, AZ: "The U.S. clinical trial was the first such comparison between total ankle replacement and fusion measuring the quality of ankle function following surgery. The STAR's superiority has been reaffirmed in a long term U.S. study published this month in the journal Foot & Ankle International in which 92% of study patients were reported to be satisfied with their outcomes at a mean average follow-up of 9.1 years. The report also noted a statistically significant decrease in pain and improvement of functional outcomes.
"Ankle joint replacement is not for everyone and is restricted to carefully selected patients most likely to benefit from the procedure. Certainly, patients and family members should consult a surgeon experienced in total ankle replacement when considering their options," he added.
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.
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.