NEW YORK–(BUSINESS WIRE)– 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.
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 7th
highest-ranked health care company and was 24th 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.
1, 2 Drs. Roger A. Mann and James A. Nunley are consultants
to SBi and investigators in the S.T.A.R. Post-Approval study.
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.
For more information on SBi, please visit: www.totalsmallbone.com
Forward-looking statements
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.
