Press
Releases
Contact:
Anthony Viscogliosi
Small Bone Innovations, Inc.
P: 212.583.9370 ext. 2100
E: aviscogliosi@totalsmallbone.com
Nick Kilsby
Creative Partners, LLC
P: 203.705.9202
E: nkilsby@creativepartners.com
SMALL BONE INNOVATIONS, INC. TO
ACQUIRE S.T.A.R. TOTAL ANKLE REPLACEMENT TECHNOLOGY
NEW YORK, NY:
January 29, 2008 Small Bone Innovations, Inc. (SBi),
a single-source provider of innovation, products, technology
and education for the small bone & joint sector of the
orthopedics industry, has entered into definitive agreements
to acquire Link America, Inc., d/b/a Link Orthopaedics, The
Scandinavian Total Ankle Replacement system, known as the
‘S.T.A.R.® Ankle’, and certain assets related
to the S.T.A.R. Ankle from Waldemar Link GmbH & Co. KG
of Hamburg, Germany (‘Waldemar Link’).
The value of the transaction is not being
disclosed. The acquisition is subject to the satisfaction
of certain closing conditions. Both companies are privately
held. Outside North America, both Waldemar Link and SBi are
committed to continue to provide the highest level of service
to all customers throughout the existing global distribution
network.
The S.T.A.R. Ankle is manufactured by Waldemar
Link, and was first designed as an anatomic non-constrained,
resurfacing prosthesis in 1978 by Hakon Kofoed, MD, President
Elect of the European Foot & Ankle Society and Associate
Professor of Orthopaedics at the University of Copenhagen,
Denmark.
It was designed to be less invasive, bone
conserving and tissue preserving and a significant improvement
over the prostheses of the early 1970’s that required
resection of large portions of bone and sacrificed soft tissue
integrity.
Anthony G. Viscogliosi, Chairman, CEO &
President of SBi, said: “The current version of the
S.T.A.R. Ankle has been used clinically since 1990 throughout
the world in 27 countries with over 10,000 implantations.
There have been at least 30 clinical papers written and countless
presentations given over the past three decades on the S.T.A.R.
Ankle.”
According to Mr. Viscogliosi, there are
an estimated 65,000 ankle procedures done in the United States
annually, including an estimated 18,000 arthrodeses and ankle
replacement procedures for which the S.T.A.R. Ankle could
be used in properly selected patients, if and when it receives
FDA approval.
A US IDE (Investigational Device Exemption)
Clinical Trial was initiated in 2000 as a prospective, multi-center,
concurrently controlled study, and remains ongoing while FDA
completes its review of the PMA (Pre-Market Approval) application
for the S.T.A.R. Ankle. SBi believes this represents the most
rigorous study ever undertaken in the United States for an
ankle joint replacement prosthesis.
The study follows patients for a minimum
of 24 months. The two principal investigators were Roger Mann,
MD and Michael Coughlin, MD. There were 10 sites that enrolled
S.T.A.R. Ankle patients in the Pivotal Trial and a larger
group in the Continued Access study.
The PMA application was accepted for filing
by the FDA in March 2006. An FDA Panel recommended approval
with conditions on April 24, 2007.
SBi believes that, if and when the device
receives final approval by the FDA, the device would be the
first and only FDA approved, non-cemented mobile bearing total
ankle replacement prosthesis available to patients in the
United States.
“Currently, there are no FDA approved
mobile bearing ankles for use in the United States. The only
total ankle replacements available in the US are of the two-part,
constrained, fixed bearing design that do not restore full,
natural motion, and in order for those ankles to be used in
accordance with FDA approved labeling, they should be fully
cemented in place,” Mr. Viscogliosi said.
Massimo Calafiore, President of Link America,
said: “We are very pleased to have entered into this
agreement with SBi. Throughout the process SBi demonstrated
focus, continuing enthusiasm and commitment to this opportunity.”
Andy Greenberg, Managing Director of Link
America, said: “The US IDE Clinical Trial has required
a tremendous decade long commitment from all the surgeons
and staffs involved - who agreed to participate for no other
reason than to attempt to improve the lives of patients. Helmut
D. Link, Chairman of Link America, and I want to thank everyone
personally for their efforts.”
The inventor of the S.T.A.R. Ankle, Dr.
Kofoed, noted: “The experience from the 1970’s
showed significant individual differences between a patient’s
ankle pathologies and that patients need more than a 2-piece
device. A 3-piece mobile-bearing ankle prosthesis allows the
ankle to find its own direction and accommodate patient variability.”
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/orthopedic
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 more than 140 employees at
facilities in New York, NY, Morrisville, PA, and Bourg-en-Bresse,
France, among other locations worldwide.
For more information on SBi, please visit:
www.totalsmallbone.com
About Viscogliosi Bros., LLC
Established by Marc R. Viscogliosi, John
J. Viscogliosi and Anthony G. Viscogliosi in New York City
in 1999, Viscogliosi Bros., LLC (VB) was the first venture
capital/private equity and merchant banking firm dedicated
exclusively to the musculoskeletal/orthopedics sector of the
health care industry. As principals of VB, the Viscogliosi
brothers have a combined total of nearly half a century of
experience analyzing and investing in the musculoskeletal/orthopedics
sector.
VB’s mission is to create, build and
finance companies founded on innovations developed by surgeons
and uniquely focused on “life changing” musculoskeletal/orthopedic
technologies. VB has worldwide surgeon, industry and trade
relationships, and significant financial expertise in the
musculoskeletal/orthopedic sector.
The Viscogliosi brothers have pioneered
more than 170 financial, strategic and management initiatives
for companies in the musculoskeletal/orthopedic sector, from
start-up, seed and development stage all the way to exit.
These initiatives have helped people live better lives through
the orthopedic and spinal products developed, marketed and
sold by the companies VB has assisted in developing and financing.
For more information about VB, please visit:
www.vbllc.com
Forward-looking statements:
This press 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.
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