SMALL BONE INNOVATIONS, INC. RECEIVES US FDA 510(k) CLEARANCE FOR RADIAL HEAD (rHead™) EXTENDED STEM
• Supports and enhances expansion of upper limb continuum of care product portfolio
• Adds to the versatility of our algorithmic Elbow Management System
New York, NY: January 24 2011 – Small Bone Innovations, Inc. (SBi), an orthopedics company focused exclusively on serving patients and their physicians with technologies and treatments for joint repair (arthroplasty) and trauma reconstruction around the small bones & joints of the thumb, fingers, hand, wrist, elbow, toes and foot & ankle announced that it has received 510(k) pre-market clearance notification from the U.S. Food and Drug Administration (FDA) for the radial Head (rHead™) Extended Stem to be used in the correction of complex elbow instabilities and/or elbow reconstruction.
The rHead Extended Stem further expands SBi’s upper limb product line. It is intended to be used in conjunction with SBi’s Elbow Management System (EMS), which incorporates an algorithmic approach to provide surgeons an array of solutions for treating elbow fractures. Addition of the rHead Extended Stem to EMS increases treatment options for elbow fractures where fixation may be inadequate.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "The rHead Extended Stem was designed to be easily integrated with the EMS and provides surgeons greater flexibility to treat complex elbow fractures. The addition of the extended stem to our product portfolio is another step towards creating the most attractive, anatomically-focused product portfolio dedicated to restoring form, function and motion while alleviating pain in upper limb joints. This also reinforces SBi's commitment to work with key opinion leaders to continue to provide product solutions that serve the full range of clinical needs of surgeons and their patients."
SBi has been attracting considerable attention in recent months in both the financial and the orthopedics sector. Out of nearly 5,200 companies considered, SBi was the only orthopedic company on the list of the top 50 U.S. VC-backed companies in the Wall Street Journal article "Sizing Up Promising Young Firms" on March 9, 2010. Additionally, SBi was the 7th highest ranked healthcare company and was 24th amongst all 50 companies highlighted.
SBi closed on $12 million in Series E funding from Olympus Corporation in March 2010. The company secured a $30mm debt facility from Fortress Investment Group to fund accelerated business expansion and refinance existing indebtedness in November 2009. The company in mid 2009 closed on $144 million in Series D and Series C funding from a host of investors including, Goldman, Sachs & Co., Khazanah Nasional Berhad (the investment firm of the Government of Malaysia), Malaysian Technology Development Corporation (MTDC), an integrated Malaysian-based venture capital company, The Family Office of Bahrain, Viscogliosi Brothers, LLC, Trevi Health Ventures, NGN Capital, 3i Group, and TGap Ventures, among others.
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC (VB), a New York-based merchant banking firm that specializes in the musculoskeletal/orthopedics sector. VB created SBi as the first company to focus purely on small bones & joints. By integrating established companies and professionals in the field, SBi offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in small bones & joints. Today, 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.
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.