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PRESS RELEASES
SMALL BONE INNOVATIONS, INC. RECEIVES US FDA
510(k) CLEARANCE FOR MINI-RAIL FIXATION SYSTEM AND LARGE CANNULATED
SCREW SYSTEM
- Supports and enhances expansion of lower limb continuum
of care product portfolio
- Innovative instrumentation and versatility may reduce OR
time
NEW YORK, NY: February24, 2010 - –Small
Bone Innovations, Inc. (SBi), a leading, privately-held orthopedics
company focused exclusively on technologies and treatments for the small
bones & joints, announced that it has received 510(k) pre-market
clearance notifications from the U.S. Food and Drug Administration (FDA)
for Mini-Rail Fixation System (‘Mini-Rail System’) and large
Cannulated Screw System for use in lower limb reconstruction and repair
procedures.
The Mini-Rail and Cannulated Screw systems further expand SBi’s
lower limb continuum of care product line.
SBi expects its Mini-Rail System to be used in common procedures such
as first MTP (metatarsophalangeal) joint arthrodesis and distraction,
subtalar fusion, and Jones fracture management. There are approximately
65,000 of these procedures performed annually in the U.S.*
The Mini-Rail System is a unique and highly adjustable fixation system
that lets surgeons quickly achieve optimal placement in the bones of
fixation “half” pins. The system’s ease of use can
decrease OR time. The Mini-Rail System was launched following a series
of extensive evaluations by U.S. foot and ankle surgeons.
Guido LaPorta, DPM, FACFAS, Chief of Foot and Ankle Surgery at Community
Medical Center, Scranton PA., said: "The SBi Mini-Rail System offers
a versatile solution for small bone reconstruction and trauma. The system’s
design allows it to be used as primary or complementary fixation in
arthrodesis, osteotomy, bone lengthening and fracture repair. The system’s
unique instrumentation allows us to employ the Mini-Rail System as an
anatomically accurate and rigid construct.”
SBi expects the large Cannulated Screw System, made out of stainless
steel, to be used for a variety of foot and ankle procedures including
triple arthrodesis, subtalar and ankle fusions. There are approximately
50,000 of these procedures performed annually in the U.S.*
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “Both
the Mini-Rail and large Cannulated Screw systems have been designed
specifically for use in a wide range of lower limb procedures to reinforce
and enhance the company’s goal of developing the most attractive,
anatomically-focused product portfolio available for use by foot and
ankle surgeons. These systems reinforce SBi’s commitment to work
with key opinion leaders to provide product solutions that serve the
full range of clinical needs of surgeons and their patients.”
* Source: Ortho Fact book – Knowledge Enterprise, 2005
Guido LaPorta, DPM, FACFAS provides consulting services to SBi.
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi), founded in 2004 by Viscogliosi Brothers,
LLC, (VB), the New York-based merchant banking firm specializing in
musculoskeletal/orthopedics, is 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. SBi has facilities in New York; Morrisville,
PA; Bourg-en-Bresse, France; Donaueschingen, Germany and Kuala Lumpur,
Malaysia.
For more information, 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.
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