STAR™ TOTAL ANKLE REPLACEMENT BEING COVERED IN MASSACHUSETTS AND RHODE ISLAND UNDER TUFTS HEALTH PLAN
NEW YORK, NY: May 5, 2011 –Small Bone Innovations, Inc. (SBi) announced today that effective July 1, 2011, Tufts Health Plan, covering approximately 742,000 members in Massachusetts and Rhode Island, is revising its reimbursement policy to cover SBi's STAR™ total ankle replacement system. The decision means that 98 percent of all privately-insured lives in Massachusetts will have access to total ankle replacement.
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.
Tuft's policy change extends STAR ankle coverage to more than 92 percent or 161 million of all 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 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 last year 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 261 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.
Henry DeGroot III, MD, an orthopedic surgeon in Newton, MA, who worked with Tufts Health Plan administrators to amend the insurer's policy, said: "The STAR ankle is an example of a clinically proven and highly beneficial technology becoming available to U.S. patients through a compelling body of evidence in the form of a PMA study and more than 90 clinical papers. This paradigm shift in how payors think about total ankle replacement and the growing awareness of its benefits to patients could result in its replacement of ankle fusion as the gold standard for treating mid-to-late stage ankle arthritis."
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.