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PRESS RELEASES
Contacts: Anthony G. Viscogliosi, Viscogliosi Bros, LLC (212) 583-9700
ext. 101
Chris Storer, Creative Partners (203) 952-6403
SMALL BONE INNOVATIONS LAUNCHES TISSUE TECHNOLOGY UNIT FEATURING ReFIX™
AND ARTELON® BIOMATERIALS PLATFORMS
NEW YORK – November 22, 2005 - Small
Bone Innovations, LLC (SBI) has launched a new business unit to develop
and market tissue technology applications designed to repair and restore
function to small bones and joints.
The unit is launching a newly approved, proprietary line of SBI ReFIX™
bioresorbable fracture fixation screws and pins, following receipt of
510(k) pre-market notification clearance from the U.S. Food and Drug
Administration (FDA).
In addition, SBI has accelerated its marketing efforts to support the
Artelon® CMC-I spacer for treating basal thumb osteoarthritis. The
CMC-I spacer is a biodegradable implant that can eliminate the need
to remove the trapezial bone and has been shown to restore thumb functionality.
ReFIX™ products are built on a bioabsorbable polyester platform
that is slowly metabolized by the body, thereby eliminating the need
for post-operative removal of the fixation device. The products will
compete directly with metal and other polymeric fixation devices used
to treat trauma and disease-related indications. These include fixation
and/or alignment of apical, osteochondral and cancellous fragments of
fractured non-load bearing bones, osteotomies and arthrodeses.
Michael J. Simpson, President & COO at SBI said: “In trials,
the ReFIX™ system met surgeon needs for optimum precision, speed
and flexibility in fixation procedures. A further advantage is the provision
of a single instrument set equipped for use with all pin and screw sizes
in one set,” he added.
The Artelon® CMC-I Spacer is marketed under license from Artimplant,
AB, Sweden, and uses a polymeric formulation woven into fabric that
can act as a joint spacer while minimizing excessive tissue removal.
Use of the material as a spacer received 510(k) pre-market notification
clearance from the FDA in September 2004 and is being marketed worldwide
through SBI’s global sales force.
Terrence O’Donovan, MD, a prominent Baltimore hand surgeon who,
in the past six months, has completed the greatest number of Artelon®
implants, in the US, says: “The post-operative effect of the spacer
on patients has been significant pain reduction and a marked increase
in function – or pinch strength. These results are very encouraging
although it will require years before reaching any clinical conclusions.”
Alejandro Badia, MD, a leading hand surgeon based in Miami, FL, who
together with Dr. O’Donovan, conducted a skills workshop for surgeons
at the annual American Society for Surgery of the Hand (in San Antonio,
TX, Sept. 22-24) noted that: “The use of tissue sparing technology
holds immense promise in treating basal thumb osteoarthritis that particularly
afflicts women – predominantly peri-menopausal. We believe that
procedures capable of restoring function are a compelling alternative
in lieu of drug therapy or more aggressive surgical procedures that
are currently performed.”
Anthony G. Viscogliosi, Chairman & CEO of SBI said: “These
biomaterial-based surgical solutions represent the next wave in small
bone and joint treatment that leverages the body’s ability to
heal itself. They are an essential part of our objectives to develop
innovative biodegradable materials and implants that meet the growing
needs of patients and surgeons to restore small bone and joint function
as well as eliminate pain.”
About SBI
Small Bone Innovations, LLC (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); Fixano, S.A.S. (orthopedics,
trauma and spine products - France).
For more information on SBI 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, 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 more than 35 years experience analyzing and investing in the musculoskeletal/orthopedics
sector. The have pioneered innovative financial, strategic and management
initiatives for 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.
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