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SMALL BONE INNOVATIONS RECEIVES EUROPEAN UNION CE MARK FOR ITS PRECISE SD™ VOLAR DISTAL RADIUS PLATING SYSTEM

  • Extends SBi’s Wrist Management Portfolio
  • Addresses Most Common Fracture Faced by Hand Surgeons
  • Geometry Provides Optimized Fit for a Broad Range of Anatomic Variations

NEW YORK, NY: February 19, 2009 - Small Bone Innovations, Inc. (SBi), a single-source provider of products, technology and education for the small bone and joint sector of the orthopaedics industry, announced that it has received the European Union CE Mark (Conformité Européene) for its PRECISE SD™ Volar Distal Radius Locking Plate system for a wide range of wrist trauma repair and reconstruction procedures.

The PRECISE SD system was developed by SBi and launched in the US earlier this year. The declaration of the CE Mark now makes it available to surgeons throughout the European Union (EU).

The PRECISE SD plate geometry is based on computer analysis of CT (Computer Tomography) data generated from a broad series of distal radii in the Hamann Todd Osteological Collection at the Cleveland Museum of Natural History. The result is an anatomic locking plate that SBi believes provides optimized fit and improved articular support for bone trauma over a broad range of anatomic variations. The plate’s polyaxial locking screw technology is a patented*, low profile design with a proven clinical track record.

Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “Fracture of the distal radius is the most pervasive injury requiring treatment by hand surgeons.”

“In the course of developing a wrist treatment algorithm, surgeons told us they needed a fixation system able to achieve a lower profile and more precise fit where the degree of bone fragmentation is unusually complex such as in the estimated 250,000 older patients with symptoms of osteoporosis who annually fall and suffer a fractured wrist,” he added.

The PRECISE SD’s low profile, polyaxial design offers up to +/- 15 degrees of variable angle opportunity in locking or non-locking configurations while a Type II surface coating on plates and screws increases strength, reduces the risk of cold welding between the plate and screws, and reduces tissue adhesion.

Jesse B. Jupiter, MD**, Orthopaedic Hand Service, Massachusetts General Hospital, Boston, MA noted that: “Technological advances in three-dimensional imaging present a more precise picture of wrist fractures and that has led inevitably to demand for screw and plating systems capable of providing a correspondingly precise fit – as is the case with the PRECISE SD design.”

The advanced locking technology found in the PRECISE SD Plate allows a surgeon to insert polyaxial locking or non-locking screws and pegs at variable angles to the plate to address the location and geometry of a fracture or osteotomy.

“Because the screws and pegs are slightly harder than the plates, the thread in the locking screw reshapes the softer titanium of the PRECISE SD plate, creating a secure construct between the head of the screw and the plate,” Dr. Jupiter added.

The introduction of the PRECISE SD system extends SBi’s wrist management portfolio following its rollout of the RE-MOTION™ Total Wrist Implant and STABILITY Sigmoid Notch Total DRUJ System™ - incorporating Precise Guidance Technology™ that allow surgeons to perform wrist arthroplasty and reconstruction procedures with consistent and predictable outcomes.

SBi President, Thomas A. Crowley, noted that: “The availability of these completely modular systems enables surgeons to manage the varying degrees of severity in wrist injuries. Also, we believe the affects on small bones and joints of degenerative diseases such as osteoarthritis and osteoporosis may be treated at every stage of progress with the possibility of restoring near natural motion and function without undue sacrifice of tissue or frequent revisions.”

According to a University of California, San Diego Medical Center study, one in twelve women will suffer a wrist fracture in their lifetime. Also, in the same study, the wrist is the body part most frequently broken among patients under the age of 65.

* Licensed by SBi from Prof. Dietmar Wolter, Hamburg, Germany.

** Dr. Jupiter has consulted for SBi on surgeon education.

About Small Bone Innovations, Inc.
Small Bone Innovations, Inc. (SBi) was founded in 2004 by Viscogliosi Brothers, LLC, (VB), a 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 bones & joints. By integrating established companies and professionals in the field, SBi offers a broad, clinically proven portfolio of products and technologies to treat trauma and diseases in small bones & joints. Today, SBi has more than 140 employees at facilities in New York, NY, Morrisville, PA, and Bourg-en-Bresse, France, among other locations worldwide.

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 exclusively to the musculoskeletal/orthopedics sector of the health care industry. 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.

VB’s mission is 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.

The Viscogliosi brothers have pioneered more than 170 financial, strategic and management initiatives for companies in the musculoskeletal/orthopedic sector, from start-up, seed and development stage all the way to exit. These initiatives have helped people live better lives through the orthopedic and spinal products developed, marketed and sold by the companies VB has assisted in developing and financing.

For more information about VB, please visit: www.vbllc.com

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.

 

 
 
 
 
 


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