Press
Releases
Contacts: Anthony Viscogliosi, Small Bone Innovations, Inc. (212)
583-9700 ext. 2100
Nick Kilsby, Creative Partners PR, (203) 705-9202
SMALL BONE INNOVATIONS, INC. ROLLS OUT NEXT GENERATION
RINGFIX™ SYSTEM AND INTRODUCES FOREFOOT REPAIR SETS
Featured on CBS TV Early Show, 10.17.07 - LINK
New
York, NY: October 19th, 2007 - Small
Bone Innovations, Inc. (SBi), a single-source provider of innovation,
products, technology and education for the small bone & joint
sector of the orthopedic industry, has rolled out its ‘next
generation’ model of its RingFIX™ Circular Fixation
System to treat diseases and trauma of the lower limb such as Charcot
foot. SBi also reported that it had received FDA market clearance
to introduce a series of “FootFIX” forefoot fixation
pins, staples and screws to expand its lower limb portfolio.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “With
RingFIX as the focal point of our drive toward total technology
coverage in foot & ankle treatment, these next-generation, surgeon-innovated
versions of clinically proven external fixation systems put SBi
ahead of schedule in its goal to be the provider of choice in the
small bone and joint sector.”
The RingFIX system has been modified to accommodate a wider range
of foot & ankle conditions than its predecessor. It was marketed
previously in Europe under the Fixano brand (a French company acquired
by SBi in 2005). The device had an 18 year history of successful
clinical use using the principles of the Ilizarov technique for
limb preservation and correction of deformity through reconstruction
and restoring function using external fixation.
The current system, cleared for marketing by the FDA earlier this
year, comprises 208 components including stainless steel half pins,
rods, drill & bayonet tip wires, 53 light alloy rings and aluminum
or carbon fiber foot plate options.
The dominating growth factor in lower limb disease is treatment
of Charcot foot deformity and ulceration associated with diabetes.
Other FDA-cleared indications include ankle fractures, limb lengthening
and treating bone and joint deformities or defects.
Michael S. Pinzur, MD, Professor of Adult Orthopaedics & Rehabilitation
- Foot & Ankle Surgery - at Loyola University Medical Center
in Chicago, said: “There is a growing body of clinical evidence
that the use of sophisticated external fixation technology such
as the RingFIX circular fixation device represents a tissue sparing
and function restoring alternative to amputation for diabetic patients.”
More than 60% of non-traumatic lower limb amputations occur in people
with diabetes – approximately 75,000 in 2003, according to
the US Centers for Disease Control.
Mr. Viscogliosi noted that: “An even more distressing statistic
is that 85 percent of amputations could be avoided through early
intervention and diagnosis. Of all treatment methods offered by
SBi and the industry generally, this is a huge opportunity to dramatically
alter outcomes and, in essence, restore hope by saving both the
form and function of the lower limb.”
SBi’s goal of establishing a comprehensive foot and ankle
management system has been boosted further by recent FDA 510(k)
clearances of forefoot repair components as a part of its “FootFIX”
product line for bone reconstruction, osteotomy, arthrodesis and
fracture repair.
The newly cleared products include: StaFIX™ threaded staples;
PercuFIX™ threaded pins; and TwistoFIX™ compression
screws in a complete forefoot fixation set. SBi anticipates more
additions to its foot and ankle portfolio following the completion
of several transactions during the past year involving licenses
and technology acquisitions.
The StaFIX stainless steel threaded staple set is designed for repair
of small bone fractures in the foot, osteotomy, fusions and soft
tissue re-attachment. The set contains three sizes of staple in
a straight and angulated configuration, while the straight soft
tissue staple comes in four sizes. The threaded ends facilitate
ease of removal.
The PercuFIX ‘break-away’ percutaneous titanium alloy
pins (in 5 lengths, 1.8 mm dia.) require no use of a wire cutter
and are threaded for ease of removal. The TwistoFIX self-drilling/self-tapping
screw set (in 5 sizes, 2mm dia.) with accompanying clamp enables
the surgeon to determine precisely screw length and placement.
Anthony G. Viscogliosi, SBi’s CEO, noted: “We are determined
to offer the widest, deepest and most anatomically focused portfolio
of products to cover the entire continuum of foot and ankle care
and these new product launches are a major step in that direction.”
* * * * * * * * * * * * *
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.
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