SBI Reports Strong Sales of STAR Ankle Implant

Officials at Small Bone Innovations (SBI) reported continuing growth for venture capital-backed firm’s S.T.A.R. ankle arthroplasty implant system. August, company execs noted, was the strongest showing so far for the device in terms of revenues and surgeries. The company previously has reported strong revenue growth in its small bone and joint portfolio of 35 percent in the first half of 2010.

SBI primarily is focused on arthroplasty and trauma reconstruction technology and treatments for the small bones and joints.

Anthony G. Viscogliosi, SBI’s chairman and CEO, 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 percent more than in July.”

According to Roger A. Mann, M.D., one of the surgeons who lead the clinical trail that led to the U.S. Food and Drug Administration’s (FDA) approval of the S.T.A.R. device, a solid clinical trial track record helped to bolster the implant’s clinical and financial performance thus far.

“Like any innovative technology, most surgeons and patients like to wait and see,” Mann said. “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 percent 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.”

Viscogliosi added that one-on-one training sessions conducted with foot and ankle surgeons during the last several months, along with the new instrumentation, also have played a role.

Of the approximately 390,000 patients in the United States 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 S.T.A.R. total ankle replacement system received premarket approval (PMA) from the FDA in May last year, and is indicated for replacement of painful arthritic ankle joints affected by osteoarthritis, post-traumatic arthritis or rheumatoid arthritis. According to the company, S.T.A.R. is the only three-piece, cement-less, 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 United States. Company officials claim the device’s titanium plasma spray coating allows for better bone in-growth, stabilization and bone preservation.

In March, SBI closed it most recent round of funding—Series E—receiving on $12 million from Olympus Corporation in March 2010.