|
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.
Copyright © Small Bone Innovations, Inc., 2005-2006.
> Back to Press Releases
|
|
