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  • SBi provides unrestricted educational grant to the international Task Force on Charcot Arthropathy
  • Further strengthens its commitment to being a leader in the treatment of diabetic Charcot foot / limb salvage

PARIS--(BUSINESS WIRE)--: February 23, 2011 – An international Task Force on Charcot arthropathy, supported by unrestricted educational grants from Small Bone Innovations, Inc. (SBi) and other orthopedics companies, has reached agreement on new recommendations for the effective treatment of diabetic Charcot foot.

According to the World Health Organization an estimated 285 million people, 6.4% of the world's adult population, are thought to have diabetes and that is expected to grow to 438 million by 2030. In the U.S. alone, more than 80,000 lower limb amputations are annually performed on people with diabetes.

The Task Force, comprising experts in diabetic foot disorders and Charcot arthropathy was convened on January 31, 2011 at the Pitié-Salpêtrière Hospital in Paris by the American Diabetes Association (ADA) and the American Podiatric Medical Association (APMA). The Task Force reported that it reached a consensus on the definition, pathophysiology, diagnosis, and recommended treatment of Charcot foot.

The legendary French hospital fostered the work of Dr. Jean-Martin Charcot (1825-1893), widely recognized as the founder of modern neurology and the first observer of the neuropathic foot condition first seen in syphilis but now most commonly associated with diabetes.

The condition develops as a result of neuropathy or nerve damage, which decreases the ability to sense temperature changes, pain or trauma, especially in the feet. The bones in the feet become progressively weak enough to fracture and can eventually alter shape, resulting in foot ulcers, tissue infections, severe deformity, disability and even amputation. Diabetes and neuropathy are precursors to the condition.

According to the ADA, about 8% of the US population has diabetes and roughly 50% of those have signs of neuropathy. According to the International Diabetes Federation, the Middle East – North Africa (MENA) region will have the second highest comparative prevalence with 9.3% of those aged 20 to 79 years affected by diabetes in 2010. The Western Pacific region will have the largest number of people with diabetes with 77 million in 2010. A seemingly minor trauma sparks the Charcotfoot process and the condition develops rapidly thereafter.

The detailed Task Force report and recommendations will be published jointly in Diabetes Care and the Journal of the American Podiatric Medical Association later this year and presented at scientific meetings of both associations.

In 2007, the latest year for which data are available, the ADA estimates that the total cost of diagnosed diabetes in the U.S. was $174 billion, of which $116 billion was spent on direct medical costs for diabetes. At least 33% of these direct medical costs were linked to the treatment of ulcerated feet.

Lee C. Rogers¹, DPM, co-chair of the Task Force and Associate Medical Director of the Amputation Prevention Center at Valley Presbyterian Hospital in Los Angeles, CA said: "Our 18-member Task Force representing six nations, discussed our frustration with the misdiagnoses, delayed diagnoses, and poor treatment of the Charcot foot. The Task Force is excited about newer developing treatments, but first, we need to combat things like lack of symptom recognition, ignorance of the consequences, and reluctance of doctors to prescribe effective treatments."

Task Force member Michael S. Pinzur¹, MD, Professor of Adult Orthopaedics & Rehabilitation - Foot & Ankle Surgery - at Loyola University Medical Center in Chicago, said: "There is a growing body of clinical evidence that the use of sophisticated external fixation technology (such as SBi's RingFIX™ System), represents a tissue sparing and function restoring alternative to amputation for diabetic patients."

SBi is an orthopedics company focused exclusively on serving patients and their physicians with technologies and treatments for joint repair (arthroplasty) and trauma reconstruction around the small bones & joints (SB&J) of the thumb, fingers, hand, wrist, elbow, toes and foot & ankle. It organizes workshops to teach circular fixation techniques using RingFIX and the RingFIX™ RAD (Rozbruch Ankle Distraction) technologies to treat a wide range of foot and ankle conditions, trauma and deformities including Charcot foot repair.

Anthony G. Viscogliosi, Chairman & CEO of SBi, one of the underwriters of the Task Force meeting, noted that: "There are some distressing statistics linked to diabetes and its potential to devastate large portions of the global population but the one relating to avoidable amputations cries out for early intervention and diagnosis. Our industry's cooperation with foot and ankle specialists exemplified in this group represents a huge opportunity to dramatically alter outcomes and, in essence, restore hope by saving not only the form and function of the lower limb but ultimately extending life."

¹Lee C. Rogers, DPM & Michael S. Pinzur, MD are paid consultants providing education services to SBi.

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 facilities in New York, NY, Morrisville, PA, Bourg-en-Bresse, France, Donaueschingen, Germany, and Kuala Lumpur, Malaysia and has sold its products in 46 countries.

Forward-looking statements
This news 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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