NEW YORK--(BUSINESS WIRE)--Please replace the release dated May 23, 2012 with the following corrected version due to multiple revisions.
The corrected release reads:
TEXAS WORKERS COMPENSATION DEPARTMENT ADOPTS MEDICAL TREATMENT GUIDELINES
Small Bone Innovations, Inc. (SBi), a leading, privately held orthopedics company focused exclusively on arthroplasty and joint-related trauma technologies and treatments for the small bones and joints, reported that the Texas Dept. of Insurance - Division of Workers Compensation (DWC) has adopted medical treatment guidelines that support coverage of total ankle replacement treatment approved by the US Food and Drug Administration (FDA) through its Premarket Approval (PMA) process when meeting certain patient guidelines. SBi corrects and replaces its press release of May 23, 2012 to clarify that neither DWC nor the State of Texas recommends any product.
According to the U.S. Bureau of Labor Statistics for 2010, there were approximately 7,000 reported cases in Texas of foot and ankle disability among private sector employees.
The STAR ankle is the only total ankle replacement system approved 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 an FDA- regulated, multi-center, multi-year, concurrently-controlled, Investigational Device Exemption (IDE) study. The IDE study results, published in 20091, demonstrated STAR to be superior in efficacy and comparable in safety to fusion. Subsequent studies show that the STAR ankle has better pain relief, greater clinical success, less blood loss and a shorter operating time than fusion.
Michael P. Simpson, President & CEO of SBi, said: “The adoption of the medical treatment guidelines by the Texas DWC is indicative of the transformation in the orthopedic landscape in which technologies, bolstered by superior clinical data, have established a clear competitive advantage.”
Anthony G. Viscogliosi, Founder & Executive Chairman of SBi said: “Our long-term business strategy of always taking the high road by developing long-term clinical data and going through stringent regulatory processes is paying off.
“We believe the Texas DWC’s adopted guidelines reinforce the value of the clinical, regulatory, and reimbursement pathways that companies need to take to demonstrate superiority,” he added.
SBi says that more than 60 foot and ankle surgeons in Texas have been trained in the STAR procedure among a total of 700 surgeons nationwide. Also, the company reports in excess of 20,000 patients worldwide have received a STAR ankle implant.
James W. Brodsky2, MD, Clinical Professor of Orthopaedic Surgery at the University of Texas Southwestern Medical Center and Director of the Foot and Ankle Surgery Fellowship Training Program at Baylor University Medical Center in Dallas, said: “A significant benefit of the STAR from both the patient and surgeon perspectives is the ability to implant the prosthesis without needing to use cement – a distinction not shared with any other FDA-cleared ankle replacement.
“Recent clinical studies of the STAR total ankle demonstrated the efficacy of this procedure as an important new alternative to ankle fusion – a traditional procedure that eliminates pain but does not restore ankle joint function or normal gait among patients,” he added.
Since September 2011, the STAR ankle has become available to 100% (about 175 million) of privately insured health plan members in the U.S. In addition, the STAR ankle is also available to 100% (about 100 million) eligible individuals covered by governmental insurance programs, such as Medicare, Medicaid and TRICARE.
¹ Charles L. Saltzman et al: ‘Prospective Controlled Trial of STAR Total Ankle Replacement Versus Ankle Fusion: Initial Results’ Foot & Ankle International/Vol.30, No. 7/July 2009
2 Dr. Brodsky provides consulting services to SBi
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, Péronnas, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia and has sold its products in 41 countries.
For a notice on Forward Looking Statements and more information about SBi, please visit: www.totalsmallbone.com/us/press.php4 For product and patient information on the STAR ankle please visit: www.star-ankle.com and www.staranklereplacement.com