Small Bone Innovations, Inc. (SBi) today announced that on Sept. 30, 2014 the sale of the assets of its international business, including the assets of its French, German and Asia Pacific operations, to Stryker Corporation (NYSE:SYK) was completed.
“With its global sales, marketing and distribution resources, Stryker is well positioned to take SBI’s full range of arthroplasty products to a much greater patient population, and, in particular, the STAR total ankle replacement system. The STAR Ankle is the number one total ankle replacement system in the world and is the only total ankle replacement system approved for uncemented use through the U.S. Food and Drug Administration’s (FDA) rigorous Premarket Approval (PMA) process. The Investigational Device Exemption (IDE) study, which was a prerequisite to obtaining PMA, demonstrated STAR to be ‘superior in efficacy and comparable in safety to fusion.’ 1 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. The low profile and bone conserving design favored by patients combined with its simple, easy to use instrumentation system favored by surgeons has led to its favorable reception in the marketplace,” said Anthony G. Viscogliosi, chairman and CEO of SBi.
“We believe the ankle market is at an inflection point of conversion from fusion to arthroplasty and STAR Ankle will be driving the market as a product innovator and the most clinically researched total ankle system in the world. Furthermore, the STAR ankle replacements last long term and provide relief for patients as demonstrated by the long-term study conducted by foot and ankle surgeons Jeffrey A. Mann M.D., Roger A. Mann M.D. and Eric Horton M.D. that reported 91 percent survivorship at an average follow-up of 9.1 years with 92 percent patient satisfaction2.
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 Foot & Ankle International (May 2011 edition, Volume 32 #5 © American Orthopaedic Foot & Ankle Society)
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 arthroplasty. It offered a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in the small bones & joints. From facilities in Morrisville, Pennsylvania, Péronnas, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia, SBi sold and distributed 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.