Contacts: Anthony Viscogliosi, Small Bone Innovations, Inc. (212)
583-9700 ext. 100
Nick Kilsby, Creative Partners, (203) 750-9212, Cell: 203-829-6400
SURGERIES COMPLETED USING SBI'S NEWLY INTRODUCED UNI-ELBOW RADIO CAPITELLUM
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
(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
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
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
“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.
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.
In establishing SBi, VB acquired several prominent US, Canadian and
European orthopedic device companies and product technology licenses
focused on small bone and joint treatment, including arthroplasty, internal
& external fixation, trauma, and biologics.
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.
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
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
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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