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PRESS RELEASES
Contacts: Anthony Viscogliosi, Small Bone Innovations, Inc. (212) 583-9700
ext. 100
Nick Kilsby, Creative Partners, (203) 750-9212, Cell: 203-829-6400
SMALL
BONE INNOVATIONS, INC. ANNOUNCES IT’S NEW LATERAL rHEAD™
FOR TREATMENT OF RADIAL HEAD FRACTURES & DISEASES IN THE ELBOW
- Allows for lateral access and placement
- Less invasive
- Strengthens the SBi Elbow Management System
NEW YORK NY, February 15, 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 announced the latest technology addition
to its growing and impressive family of Elbow Management System products,
its new Lateral rHead™ implant.
SBi has debuted its Lateral rHead™ at the American Academy of
Orthopaedic Surgeons (AAOS) 2007 Annual Meeting in San Diego, California
– on display at Booth # 2532 in the San Diego Convention Center,
9:00am to 5:00pm, Wednesday, February 14th through Friday, February
16th.
The Lateral rHead™ is comprised of a uniquely designed mechanical
couple between the head and stem components. The couple does not require
a set screw and is provided with an easy-to-use assembly tool that can
be used in vivo or on the "back table" to quickly assemble
the head to the stem component.
Similar to SBi’s rHead and rHead Recon products, the head and
stem components are fully modular. The Lateral rHead™ head is
highly polished cobalt chrome (CoCr). The stem is cobalt chrome (CoCr)
with the stem and collar buttress coated with plasma- sprayed commercially
pure titanium (CPTi). The Lateral rHead™ received a 510(k) clearance
from the U.S. FDA in December, 2006.
SBi’s Lateral rHead™ provides surgeons with yet another
option for treating radial head fractures and disease. The unique design
allows for lateral access and placement, which is less invasive in terms
of surgical site exposure and soft tissue dissection, minimizing ligamentous
release required during the surgical procedure. It also facilitates
placement and repair in this restrictive anatomy, requires minimal resection
of the lateral collateral ligament (LCL) and preserves the annular ligament.
The new Lateral rHead™ complements SBi’s rHead™ Recon
implant, which facilitates alignment of the radio capitellum and provides
for greater anatomic positioning.
SBi’s Lateral rHead™ augments the growing SBi Elbow Management
System, a suite of the most comprehensive products and technology systems
in the industry designed to treat all conditions of fracture reconstruction
and disease management of the elbow. In addition to the new Lateral
rHead™, this suite of Elbow Management System products also includes:
The rHead™ Radial Implant System
This modular design accommodates specific patient physiology, with four
stem sizes and three head sizes. The stems are designed with a rough
finish, yielding a more receptive surface for bony in-growth, with a
uniquely shaped and patented curve for accurate medullary canal alignment.
The rHead™ Recon Radial Implant System
When proper alignment of the proximal radius cannot be achieved, the
added flexibility of the rHead™ Recon can compensate for misalignment.
The bipolar design facilitates proper radio capitellar position throughout
flexion/extension and forearm rotation.
Both the rHead™ and the rHead™ Recon are available as 6mm
Extended Collar implants, for use in patients with distally integrated
fractures or where poor bone quality makes proper implant/bone interface
problematic.
This innovative design does not require the use of spacers or washers
like other systems, and promotes stability. They are also available
with a Size 1 implant stem (with a patented, curved stem, in an identical
design to the full-size rHead™ and rHead™ Recon) for use
in very small patient anatomies. Even with a smaller stem geometry,
the Size 1 implant can be used with all existing rHead™ components.
The UNI-Elbow™ Radio Capitellum Implant
Used for post-traumatic reconstruction, degenerative joint disease,
the correction of functional deformities, and for revision procedures
where other treatments have failed, the UNI-Elbow™ is anatomically
designed for minimal resection to restore normal articulation. When
used in conjunction with the rHead™ prosthesis, the system represents
the first uni-compartmental elbow implant commercially available in
the United States.
The implant replaces the Radio Capitellum joint and preserves a normal,
healthy ulno-humeral joint and, when implanted using SBi’s Precise
Guidance Technology™ (PGT) system, is tissue-sparing and less
invasive than performing a total elbow replacement.
AutoFIX™ Cannulated Compression Screws
Available in 2.0mm and 2.5mm sizes, these stainless steel headless screws
are optimal for use in articular surfaces of joints and in areas of
minimal soft tissue coverage. An opposing buttress thread design facilitates
compression towards fracture/osteotomy.
Commenting on his company’s new elbow implant, Founder, Chairman
& CEO Anthony G. Viscogliosi said, “SBi is committed to being
the worldwide leader in the design and development of upper and lower
limb arthroplasty implants and related medical devices. The Lateral
rHEAD is the latest in a solid line of ground-breaking, surgeon-driven,
patient-focused implants that will revolutionize the treatment strategy
for fractures and diseases of the elbow. SBi will continue to push the
envelope, seeking new and innovative ways for patients to get relief
from pain as well as restoration of function.”
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.
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.
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
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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