Small Bone Innovations,
Inc. (SBi), a single-source provider of products, technology and education
for the small bone and joint orthopedic market sector, announced the
launch of the rHead(TM) Lateral Radial Head Implant System. To further
augment its Elbow Management System, the company also launched the
rHead(TM) Plating System for internal fixation of proximal radius
fractures.
The rHead Lateral Implant is a side-loading radial head prosthesis that
allows for a minimally invasive approach and exposure in radial head
replacement surgery. The head and stem of the implant connect by the means
of a dove-tail locking mechanism that does not require a set screw - saving
time in the operating room.
The rHead implant and new plating systems have received 510(k)
clearance by the FDA. The rHead Lateral is indicated for treatment of
arthritic and traumatic conditions of the radial head.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "The addition of
the rHead Lateral implant and the complementary new plating system responds
to surgeon demand for a full range of treatment options for every disease
stage or severity of trauma in the elbow."
The stem of the rHead Lateral implant is plasma coated with titanium
for immediate stability in the canal and optimum osteo-integrating
properties. As with SBi's existing rHead implants, the stem has a 12-degree
curve to match the anatomy of the radius. This stem is available with a 2
mm standard collar or a 6 mm extended collar.
"The modularity of treatment options now available from SBi is making
the often complicated alignment challenges in elbow repair or
reconstruction more manageable and predictable in outcome," said Amit
Gupta, M.D, who completed the first procedure using the Lateral rHead at
the Louisville Arm and Hand Center.
"A unique feature of the system is the coupling mechanism between the
radial head and stem that enables the implant to be implanted sideways to
reduce ligament disruption," Dr. Gupta added.
According to SBi, surgeons have been instrumental in creating the Elbow
Management System. The first rHead(TM) device was released in 1999 by
Avanta (later acquired by SBi) and two years later a bi-polar version, the
rHead Recon was introduced.
This was followed last year with the introduction of the SBi UNI-Elbow
Radio Capitellum System(TM) as the first commercially available uni-
compartmental elbow arthroplasty system. The new rHead Lateral implant
heads are approved for use with the UNI-Elbow System for patients requiring
a uni- compartmental solution.
Surgeons using SBi's Elbow Management System are also benefiting from
the company's Precise Guidance Technology (PGT(TM)) instrument system that
assists anatomical placement of the rHead implants. The trialing system
helps to size the implant to render it as minimally invasive as is
practicable.
The new rHead Lateral implant comes with an assembly tool for quick
engagement or disengagement of the head and stem. The accompanying impactor
tool is configured to assure precise positioning of the implant by
referencing the surrounding anatomy.
About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi
Brothers, 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 130
employees at facilities in New York, NY, Morrisville, PA, and
Bourg-en-Bresse, France.
SBi was a 2006 recipient of Red Herring magazine's annual "Red Herring
100 North America" award, recognizing SBi 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(R) CMC-I Spacer, developed for patients
with osteoarthritis at the base of the thumb, 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 its 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: totalsmallbone
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.
The Viscogliosi brothers 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
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 about VB, please visit: vbllc
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.
Small Bone Innovations, Inc.
totalsmallbone
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