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SMALL BONE
INNOVATIONS RECEIVES EUROPEAN UNION CE MARK FOR ITS PRECISE
SD™ VOLAR DISTAL RADIUS PLATING SYSTEM
- Extends SBi’s Wrist Management Portfolio
- Addresses Most Common Fracture Faced by Hand Surgeons
- Geometry Provides Optimized Fit for a Broad Range of
Anatomic Variations
NEW
YORK, NY: February 19, 2009 - Small
Bone Innovations, Inc. (SBi), a single-source provider of
products, technology and education for the small bone and
joint sector of the orthopaedics industry, announced that
it has received the European Union CE Mark (Conformité
Européene) for its PRECISE SD™ Volar Distal Radius
Locking Plate system for a wide range of wrist trauma repair
and reconstruction procedures.
The PRECISE SD system was developed by SBi and launched in
the US earlier this year. The declaration of the CE Mark now
makes it available to surgeons throughout the European Union
(EU).
The PRECISE SD plate geometry is based on computer analysis
of CT (Computer Tomography) data generated from a broad series
of distal radii in the Hamann Todd Osteological Collection
at the Cleveland Museum of Natural History. The result is
an anatomic locking plate that SBi believes provides optimized
fit and improved articular support for bone trauma over a
broad range of anatomic variations. The plate’s polyaxial
locking screw technology is a patented*, low profile design
with a proven clinical track record.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “Fracture
of the distal radius is the most pervasive injury requiring
treatment by hand surgeons.”
“In the course of developing a wrist treatment algorithm,
surgeons told us they needed a fixation system able to achieve
a lower profile and more precise fit where the degree of bone
fragmentation is unusually complex such as in the estimated
250,000 older patients with symptoms of osteoporosis who annually
fall and suffer a fractured wrist,” he added.
The PRECISE SD’s low profile, polyaxial design offers
up to +/- 15 degrees of variable angle opportunity in locking
or non-locking configurations while a Type II surface coating
on plates and screws increases strength, reduces the risk
of cold welding between the plate and screws, and reduces
tissue adhesion.
Jesse B. Jupiter, MD**, Orthopaedic Hand Service, Massachusetts
General Hospital, Boston, MA noted that: “Technological
advances in three-dimensional imaging present a more precise
picture of wrist fractures and that has led inevitably to
demand for screw and plating systems capable of providing
a correspondingly precise fit – as is the case with
the PRECISE SD design.”
The advanced locking technology found in the PRECISE SD Plate
allows a surgeon to insert polyaxial locking or non-locking
screws and pegs at variable angles to the plate to address
the location and geometry of a fracture or osteotomy.
“Because the screws and pegs are slightly harder than
the plates, the thread in the locking screw reshapes the softer
titanium of the PRECISE SD plate, creating a secure construct
between the head of the screw and the plate,” Dr. Jupiter
added.
The introduction of the PRECISE SD system extends SBi’s
wrist management portfolio following its rollout of the RE-MOTION™
Total Wrist Implant and STABILITY Sigmoid Notch Total DRUJ
System™ - incorporating Precise Guidance Technology™
that allow surgeons to perform wrist arthroplasty and reconstruction
procedures with consistent and predictable outcomes.
SBi President, Thomas A. Crowley, noted that: “The availability
of these completely modular systems enables surgeons to manage
the varying degrees of severity in wrist injuries. Also, we
believe the affects on small bones and joints of degenerative
diseases such as osteoarthritis and osteoporosis may be treated
at every stage of progress with the possibility of restoring
near natural motion and function without undue sacrifice of
tissue or frequent revisions.”
According to a University of California, San Diego Medical
Center study, one in twelve women will suffer a wrist fracture
in their lifetime. Also, in the same study, the wrist is the
body part most frequently broken among patients under the
age of 65.
* Licensed by SBi from Prof. Dietmar Wolter, Hamburg, Germany.
** Dr. Jupiter has consulted for SBi on surgeon education.
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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