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Contacts:
Anthony
Viscogliosi, Small Bone Innovations, Inc.
(212) 583-9700 ext. 100
Nick Kilsby, Creative Partners,
(203) 705-9202 Cell: (203) 829-6400
FIRST SURGERIES COMPLETED
USING SBI'S NEWLY INTRODUCED UNI-ELBOW RADIO CAPITELLUM SYSTEM™
Dr. Morrey, a co-designer, and Dr. Schwarzbard, an early adopter, cite
advantages of system’s approach to radio humeral reconstruction
New York, NY: January 8, 2007 - Small Bone Innovations, Inc. (SBi),
a single-source provider of products, technology and education to small
bone and joint orthopedic surgeons, announced an initial round of procedures
using its new UNI-Elbow™ Radio Capitellum System (UNI-Elbow). The
system incorporates SBi’s Precise Guidance Technology™ (PGT)
template and instrumentation.
Dr. Bernard Morrey, who co-designed the uni-compartmental implant under
an agreement between SBi and the Mayo Clinic, in Rochester, MN, began
the first, post-launch use of the system in November, and, in December,
Dr. Itzhak Schwarzbard, a Long Island, NY, surgeon, used the UNI-Elbow
device to correct an arthritic deformity and alleviate persistent joint
pain.
The UNI-Elbow, designed primarily for use in association with SBi’s
rHead™ radial head prosthesis, is the first uni-compartmental elbow
implant to become commercially available in the United States. The implant
has 510(k) clearance from the U.S. FDA and is indicated for treatment
of arthritic and traumatic conditions of the radio-capitellum joint.
The implant replaces the radio capitellum joint and preserves a normal,
healthy ulno-humeral joint and, when implanted using PGT, is tissue-sparing
and less invasive than performing a total elbow replacement. The PGT Axis
Locator Clamp, a unique technology which positions around the radio capitellum
joint and determines the anatomic center of rotation of the capitellum,
is a critical element in ensuring precise implantation.
“There are some instances in which the stability and integrity of
the radio-humeral articulation are essential, yet, the pathology requires
reconstruction of both the proximal radius and the distal humerus,”
Dr. Morrey noted. “Under these circumstances, the prosthetic replacement,
such as that offered in the Uni-Elbow design, seems to be the only viable
option to adequately address the problem. The overall concept and the
soundness of the procedure itself have prompted me to schedule several
more surgeries and we look forward to monitoring results.”
The UNI-Elbow System is based upon two reciprocating implant components,
the Radio Capitellum implant and rHead™ radial head replacement
implant system. The Capitellum Implant is made of cobalt chrome and possesses
a highly polished articulating surface. The stem of the implant is plasma
sprayed with commercially pure titanium and is anatomically designed for
minimal bone resection in order to restore normal motion. The Capitellum
Implant is available in Left and Right configurations, and Small and Large
sizes. The radial head is available in standard and bi-polar configurations.
The rHead stem possesses a
12 degree-curved stem to match the canal of the radius and can be press
fitted or cemented.
At Brookhaven Hospital, Long Island, Dr. Schwarzbard reported that his
first patient, a 71 year-old female, had her left radial head removed
12 years ago after a severe fracture from a fall. She presented sustained
elbow pain and occasional wrist pain. Imaging revealed extensive capitellum
arthritis and a 2.5mm ulnar positive wrist. This is a painful and debilitating
condition that results when the distal end of the ulna migrates into the
first row of carpal bones.
“I felt this was an ideal case for a UNI-Elbow construct as solely
implanting a radial head would be unlikely to correct either of her debilitating
conditions,”. Dr Schwarzbard reported. “We are unaware of
any option, other than a prosthetic replacement, for this difficult reconstructive
problem,” Dr. Schwarzbard said.
The smallest size Capitellum Stem was cemented into the humerus and a
Size 2 Radial Stem was cemented into the radius with a Size 2 Standard
Head.
“The result was a stable Radio Capitellum joint able to maintain
a satisfactory range of motion and correction of the ulnar deviation in
the wrist,” he added.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said, “The introduction
of the UNI-Elbow as an integrated system fulfills a long-standing demand
from surgeons that we alone could offer, due to our unique focus on small
bone and joint surgery. I consider these early indications of success
an endorsement of our continuing commitment to serve unmet needs in this
sector of the orthopedic market.”
* * * * * * * * * * * * *
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 today offers
a broad, clinically proven portfolio of products and technologies to treat
trauma and diseases in small bones & joints.
VB’s acquisitions and technology licenses include: Avanta
Orthopaedics (hand/wrist/elbow arthroplasty and trauma products
– USA); Envision (implant manufacturing
– USA); Actipore™ (porous
metal technology – Canada); Artelon®
(biologically active & biodegradable technology – Sweden); Xtremi-T
(resorbable trauma technology – USA); and Fixano,
S.A.S. (broad line of small bone & joint implants - France).
SBi completed a Series B financing, raising a record total of $42.2 million,
announced in January, 2006. 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.
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 about VB, please visit: www.vbllc.com
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