SBi reports continuing growth for S.T.A.R. ankle arthroplasty implant system

Small Bone Innovations, Inc. (SBi), a leading, privately held orthopedics company focused primarily on arthroplasty and trauma reconstruction technology and treatments for the small bones & joints, reported continuing growth for its S.T.A.R.® ankle arthroplasty implant system with August being the biggest month ever for the S.T.A.R. in terms of revenues and surgeries. The company had previously reported strong revenue growth in its small bone & joint portfolio of 35% in the first half of 2010, substantially exceeding overall orthopedic industry performance.

“The one-on-one training sessions conducted with foot & ankle surgeons over the last several months, along with the new instrumentation that has been developed, have contributed to S.T.A.R.'s increasing success.”

Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "August was our best month ever in North America for S.T.A.R. surgeries. This performance is very encouraging for a number of reasons. First, August is historically the slowest month of the year for surgeries. The global economic slowdown has had a dampening effect on the volume of elective procedures for virtually all orthopedic companies. In spite of these hurdles, the number of S.T.A.R. implantations in August was 40% more than in July."

Two of the nation's best known foot & ankle surgeons who took the lead in both the clinical trial that led to FDA's Approval Order and surgeon training for S.T.A.R., Roger A. Mann¹, MD and James A. Nunley², MD explained why the implant has been so rapidly accepted in the US.

"A distinct advantage for the S.T.A.R. ankle has been the successful results of the clinical trial that prompted the FDA to conclude that the procedure is safe, effective and superior to fusion in selected patients," Dr. Nunley noted.

He added: "On the advice of their physician, patients who may have postponed ankle surgery now understand why S.T.A.R. is the leading total ankle replacement system due to its precise guidance instrumentation and compelling clinical history. Only through the clinical trials were we able to prove that the time had come to change the paradigm from fusion to arthroplasty."

Dr. Mann added: "Like any innovative technology, most surgeons and patients like to wait and see. I have been an advocate and educator in the S.T.A.R. procedure for more than a decade and the survivability of the implant has proven to be excellent in 90% of my patients. This coupled with S.T.A.R.'s superiority in efficacy versus fusion will lead to further positively transforming the quality of life for tens of thousands of patients that previously had only fusion as a way to treat late-stage ankle arthritis."

Mr. Viscogliosi added: "The one-on-one training sessions conducted with foot & ankle surgeons over the last several months, along with the new instrumentation that has been developed, have contributed to S.T.A.R.'s increasing success."

Of the approximately 390,000 patients in the US diagnosed annually with ankle arthritis, SBi believes that as many as 70,000 of them could benefit from the S.T.A.R. implant. The company also believes it is well positioned to take full advantage of a vastly underserved market and, more importantly, enable surgeons to advance the standard of patient care.

The S.T.A.R. total ankle replacement system, that received pre-market approval (PMA) from the FDA on May 27, 2009, is indicated for replacement of painful arthritic ankle joints affected by osteoarthritis, post-traumatic arthritis or rheumatoid arthritis.

The S.T.A.R. is the only three-piece, cementless, mobile-bearing, total ankle replacement system to have received PMA approval from the FDA and the only PMA-approved total ankle replacement commercially available in the US. Its titanium plasma spray coating allows for better bone in-growth, stabilization and bone preservation.

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 health care company and was 24^th among the 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. In mid-2009 SBi 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.