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SMALL BONE INNOVATIONS, INC. ANNOUNCES EXPANSION OF LOWER LIMB BUSINESS

  • Establishment of Worldwide Diabetes & Limb Preservation Systems business unit
  • Promotion of Scott Ludecker to Vice President of new Worldwide Diabetes & Limb Preservation Systems business unit
  • RingFIX R.A.D. System Launch

NEW YORK - March 3, 2009 - Small Bone Innovations, Inc. (SBi), a single-source provider of innovative products, technology and education for the small bone & joint sector of the orthopedics industry, announced it has expanded its lower limb business beyond the recently acquired Scandinavian Total Ankle Replacement (S.T.A.R.) system. SBi’s decision to enhance its focus on the lower limb market is predicated on a significant and largely unmet surgeon and patient need for treatment within the lower limb anatomy.

Anthony G. Viscogliosi, Chairman & CEO of SBi, noted, “Official statistics* indicate that there were more than 11 million physician office visits annually in the U.S. for lower limb problems, including 800,000 ankle fractures.” He continues: “There are more than 10,000 emergency room (ER) visits for ankle problems everyday in this country. Amazingly, if you add up the numbers, over our lifetime the entire U.S. population will visit the ER for an ankle injury. Simply put, we walk on our feet everyday, and this is the reason to focus on such a tremendous need.”

Establishment of Worldwide Diabetes & Limb Preservation Systems Business Unit
SBi has established a Worldwide Diabetes & Limb Preservation Systems business unit to address a largely unmet need for lower limb salvage and deformity correction, as well as the treatment of Charcot foot disease, a deformity of the bones in the foot associated with diabetes that can lead to amputation unless treated in its earlier stages. As an illustration of the depth of patient need for this latter treatment, SBi noted that more than 60% of non-traumatic lower limb amputations occur in people with diabetes – approximately 75,000 in 2003, according to the U.S. Centers for Disease Control & Prevention.

Promotion of Scott Ludecker
To focus the company’s energy on patient needs and surgeon efforts on treatment of the lower limb, SBi announced the promotion of Scott Ludecker to Vice President of its new Worldwide Diabetes & Limb Preservation Systems business unit from his current position as Vice President of Worldwide Circular Fixation. Mr. Ludecker has 18 years of orthopedic experience, including a management position in the Trauma division of Smith & Nephew where he authored a plan to create a dedicated small bone focused business unit.

Mr. Ludecker has a proven record of rapid market penetration that has been demonstrated at SBi through the increase in RingFIX sales in the U.S., which organically grew 67% in 2008. He has played an integral role in SBi’s endeavors to expand its lower limb franchise. The current RingFIX system was cleared for marketing by the Food and Drug Administration (FDA) in 2007 with indications for ankle fractures, limb lengthening and bone and joint deformities or defects. SBi also announced that it has formed a skilled team consisting of 4 Area Market Managers to support Mr. Ludecker’s performance in his elevated role at the Company.

R.A.D. (Rozbruch Ankle Distraction) System Launch
As a central part of its new lower limb business unit, SBi announced its launch of the ‘next generation’ model of its RingFIX™ Circular Fixation System to treat lower limb disease and trauma, especially Charcot foot disease, and the RingFIX™ R.A.D. system for the indication-specific use in patients with osteoarthritis of the ankle. The R.A.D. system is an alternative to ankle arthrodesis, offering a new earlier approach for the continuum of care for patients with osteoarthritis of the ankle.

Robert G. Frykberg, DPM, MPH**, Chief of Podiatry at the Carl T. Hayden VA Medical Center in Phoenix, AZ, said: “The R.A.D. ankle distraction technology developed by S. Robert Rozbruch, MD**, Chief of Limb Lengthening & Deformity Correction Service at the Hospital for Special Surgery in New York, can be used to preserve an arthritic ankle joint. Ankle distraction is often done in conjunction with arthroscopy or arthrotomy – the distraction treatment unloads the ankle helping to promote cartilage regeneration.”

* Statistics published by the National Center for Health Statistics; Centers for Disease Control & Prevention; 2003 National Ambulatory Medicine Care Survey.

** Surgeons quoted in this release are or previously were contracted by SBi for product development work.

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/orthopedics 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 130 employees at facilities in New York, NY, Morrisville, PA, Bourg-en-Bresse, France and Donaueschingen, Germany, 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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