FDA grants pre-market clearance for SBi's rHead Extended Stem

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 7^th highest ranked healthcare company and was 24^th 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.