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PRESS RELEASES
Contacts:
Anthony Viscogliosi, Small
Bone Innovations, Inc. (212) 583-9700 ext. 100
Nick Kilsby, Creative Partners, (203) 705-9202
SMALL BONE INNOVATIONS INTRODUCES THE
ARTELON® STT SPACER TO INCREASE TREATMENT OPTIONS FOR THUMB ARTHRITIS
U.S. Food and Drug Administration clears new implant for marketing
New York, NY: September 21, 2007 - Small
Bone Innovations, Inc. (SBi), a single-source provider of products,
technology and education for the small bone and joint sector of the
orthopedic industry, announced that its Artelon® STT Spacer has
been cleared by the FDA for marketing in the US.
This product extends SBi’s line of surgically implanted, degradable
spacers to four applications with two others planned for future introduction.
SBi introduced and began marketing this unique technology in the US
in 2005 with the Arteon® CMC-I spacer for early to mid-stage osteo-arthritis
(OA) in the base of the thumb.
The Artelon STT Spacer is implanted in the scapho-trapezio-trapezoidial
(STT) joint between the scaphoid and trapezial-trapezioid bones near
the base of the thumb.
*Dr. James Nunley, Chairman of the Orthopedics Department, Duke University,
NC, said: “I am delighted to see FDA clearance of the Artelon
STT spacer and, if it proves to be as good as the CMC-I spacer, it will
be a tremendous benefit for patients likely to be presenting with a
more advanced stage of OA in the base of the thumb.”
*Dr. Amit Gupta, Assistant Clinical Professor in the Department of Orthopedics
at the University of Louisville, KY, added: “Artelon is a major
advance in the treatment of small joint arthritis by providing an inert
interpositioning material between joint surfaces that eventually degrades."
The Artelon STT Spacer is similar in size to the Artelon CMC Spacer
LG, except that it has a ‘single-wing’ design (an L-shape
vs. a T-shape), of woven, degradable Artelon fibers. The spacer is designed
to preserve the STT joint and to help restore joint function while minimizing
the need to sacrifice healthy bone and tissue.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “The
base of the thumb is one of the joints most commonly affected by osteoarthritis.
The STT joint is usually affected at a later stage in the progression
of the disease than is the more commonly diagnosed carpal-metacarpal
(CMC-I) joint.”
The addition of the Artelon STT Spacer expands SBi’s coverage
in the treatment algorithm and enables surgeons to offer a complementary
range of spacers for every stage in the continuum of this debilitating
disease.
Mr. Viscogliosi noted that widespread use of hand-held devices is increasingly
a cause of repetitive stress conditions in the thumb leading to earlier
onset of arthritis and prompting more surgical procedures such as the
use of Artelon spacers.
“As with other Artelon spacers, of which more than 3,500 have
been implanted since 2004, benefits may include restoring joint stability,
faster recovery and post-operative elimination of pain,” he added.
Prior to the introduction of the Artelon Spacer, more aggressive procedures
were and continue to be used as an initial surgical option. These procedures
often involve removal of the trapezoidium bone and replacing it with
tissue harvested from the forearm (known as an LRTI procedure) or complete
fusion of the joint.
SBi estimates that more than 40,000 of these procedures are performed
on arthritic thumbs annually and that the number could rise to 55,000
by 2010.
Mr .Viscogliosi added: “What these figures do not reflect is that
many more patients elect not to seek surgery of any type and may rely
on a combination of medication and bracing, but with Artelon technology
now being offered by several hundred hand surgeons, these patients now
have access to a much less aggressive form of treatment.”
Artelon Spacers now offer a new, less invasive, surgical option that
spares healthy bone and tissue. The Artelon® CMC Spacer Arthro,
cleared for marketing by the FDA earlier this year, permits minimally
invasive arthroscopic implantation in patients at the earliest surgical
stages of the condition.
The Artelon STT Spacer introduction stems from SBi’s world wide
marketing and licensing agreements with Artimplant, AB, of Sweden. The
Artelon STT Spacer and the recently introduced Artelon CMC Spacer Arthro,
for minimally invasive surgery, are the latest in a line of six products
either already in the market or under development. Two more spacer products
are planned for future introduction in the US: the Artelon® MTP
and Artelon® DRUJ have received European CE marks but are not yet
cleared for sale in the US.
For more details on Artelon products marketed by SBi visit: http://www.totalsmallbone.com/products/artelon.html
* Dr. Nunley has been compensated in the
past by SBI for speaking engagements relating to medical education and
marketing and may in the future be similarly compensated by SBI. Dr.
Gupta is a counterparty to a product development/royalty
agreement with SBI.
* * * * * * * * * * * * *
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi
Bros., LLC, (VB), the 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 bone & joint science. By integrating
established companies and professionals in the field, SBi can offer
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 Minneapolis, MN.
SBi closed on the sale of $42.2 million of its securities in December
2005. At the time, based on data provided by Venture Source, this was
the largest venture capital investment ever recorded in the field of
orthopedic devices.
SBi was a 2006 recipient of Red Herring magazine's annual “"Red
Herring 100 North America" award, recognized as one of the nation's
leading technology companies and the only orthopedic device company
selected among an initial entry of more than one thousand firms.
Additionally, SBi's Artelon CMC-I Spacer, developed for patients with
thumb base osteoarthritis, was featured on the cover and highlighted
within Medical Design Technology magazine's “"Year of Innovation"
issue as one of the most fascinating technologies influencing the medical
device industry.
Medical Device & Diagnostic Industry Magazine named SBi to their
list of “"50 Companies to Watch" in 2006, noting, "Small
Bone Innovations is going against the grain in its determination to
become a market leader in the small bone & joint device sector."
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 to the musculoskeletal/orthopedics sector of the health care
industry.
Today, VB is a leading independent firm with a mission 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.
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, directing literally billions of
dollars through the orthopedics industry. They have pioneered innovative
financial, strategic and management initiatives for nearly 150 companies
in the sector, from start-up, seed and development stage all the way
to exit, while helping thousands of people lead better lives through
the orthopedic and spinal products marketed and sold by the companies
they have assisted in developing and financing.
For more information on VB, go to: www.vbllc.com
Forward-looking statements
This press release may contain 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 the Company's
business including increased competition; the ability of the Company
to expand its operations and to attract and retain qualified professionals;
technological obsolescence; general economic conditions; and other risks.
Copyright © Small Bone Innovations, Inc.,
2005-2006.
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