Press Releases

KANSAS STATE WORKERS COMPENSATION PROGRAM ADOPTS MEDICAL TREATMENT GUIDELINES RECOMMENDING STAR™ ANKLE REPLACEMENT SYSTEM EXCLUSIVELY

NEW YORK, NY: June 7, 2012, –Small Bone Innovations, Inc. (SBi), a leading, privately held orthopedics company focused on arthroplasty and joint-related trauma technologies and treatments for the small bones and joints, reported that the Kansas Dept. of Labor's Division for Workers Compensation (DWC) has adopted guidelines specifying the use of SBi's STAR™ total ankle replacement implant when meeting certain patient guidelines. It is the only total ankle system being recommended by DWC based upon its adopted medical treatment guidelines.

According to the US Bureau of Labor Statistics (BLS) for 2010, there were approximately 300 reported cases in Kansas of foot and ankle disability claims 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 a multi-center, multi-year, 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. The IDE and other 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: "Nationwide, patients suffering from acute arthritis are demanding the preservation of joint function and anatomical motion in addition to pain relief. As occurred with hips and knees more than a decade ago, ankle replacement is quickly becoming the future for baby boomers who want to maintain an active lifestyle.

"The fact that the STAR has become a mainstream treatment covered by Medicare and major private insurers is a huge step, literally, in the direction of fulfilling patient demand,"he added.

Dr.h.c. Anthony G. Viscogliosi Founder & Executive Chairman of SBi added: "Kansas joins Texas as one of the first states to adopt the latest disability management guidelines for workers compensation programs that specify the STAR ankle as the only suitable ankle replacement solution.

"As a result, we are raising the level and content of communications with patients and their primary care physicians in these states to enhance knowledge and understanding of the STAR ankle's benefits," he added.

According to SBi, leading foot and ankle surgeons in Kansas have already been trained and certified in the STAR procedure and are performing total ankle arthroplasty procedures. Nationwide, over 700 surgeons are qualified to perform the procedure and in excess of 20,000 patients worldwide have received the STAR ankle, the company said.

Greg A. Horton, MD² ,a foot and ankle surgeon at the University of Kansas Hospital and one of the principal investigators in the IDE study, said: "STAR is the first ankle replacement clinically proven to preserve anatomical joint functionality and the only implant of this kind that does not need to be cemented in place, often making it a better choice than alternatives in many types of severely arthritic ankle joints."

Since September 2011, the STAR ankle is now 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 the 100 million individuals covered by governmental insurance programs, such as Medicare, Medicaid and TRICARE.

¹Charles 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.

²Dr. Horton provides educational 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.

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.

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