Enhanced Footplates, Modified Rings in Multiple Colors and
New Stainless Steel Half Pins
Ease of Construct for Broad Range of Indications
Diabetic Reconstruction, Trauma of the Foot and Ankle Addressed
NEW YORK, March 14, 2007 (PRIME NEWSWIRE) -- Small Bone Innovations, Inc. (SBi), a single-source provider of innovation, products, technology and education for the small bone and joint sector of the orthopedic industry, has announced the introduction of its next generation RingFIX(tm) Circular Fixation System to treat diseases and trauma of the lower limbs. The introduction of the RingFIX(tm) system, a surgeon-innovated, patient-driven, indication-specific technology, launches SBi's official "Year of the Lower Limb" campaign for 2007.
SBi's RingFIX(tm) is a modular, circular, external fixation system designed to accommodate patients with a large variety of clinical foot and ankle needs. Originally marketed in Europe under the Fixano brand, RingFIX(tm) has a successful 18 year history of clinical use in the global healthcare marketplace. Developed around the principles of the Ilizarov technique and originating in Russia over 50 years ago, RingFIX(tm) offers near limitless external fixation configurations servicing both pediatric and adult patients with severe conditions of the foot and ankle.
The RingFIX(tm) system includes a broad selection of interchangeable components and ring geometries, and features aluminum and carbon fiber Foot Plates. This large offering of rings in a variety of patient-pleasing colors, coupled with an assortment of struts, drill and bayonet tip wires, and now, new stainless steel Half Pins, makes RingFIX(tm) a powerful management system for treating an indication-specific, large patient population with lower limb-based clinical needs. SBi's RingFIX(tm) system as well as the new Half Pins, are 510(k) cleared for marketing and use in the United States.
The new SBi RingFIX(tm) Half Pins are stainless steel, non-tapered, self-tapping pins, available in two diameters, multiple thread lengths, and multiple overall lengths. They are essential for complex procedures such as fusions, and are designed to be used in combination with the existing RingFIX(tm) wires. The new Half Pins will offer a considerably greater opportunity for RingFIX(tm) placement options and applications for indications such as severe trauma.
The SBI RingFIX(tm) Circular Fixation System is indication-specific, and particularly proficient for treating injuries about the foot and ankle. Focused applications for RingFIX(tm) include, but are not limited to: Charcot Disease reconstructions caused by Diabetes, Triple Arthrodesis, Ankle Fusion, Ankle Diastasis, Ankle Distraction and general trauma.
Nearly 21 million Americans -- 7% of the U.S. population -- have diabetes, with approximately 1/3 of those unaware that they have the disease, according to the American Diabetes Association (ADA). The most common form of the disease, Type 2 diabetes, accounts for 90 to 95 percent of the cases. As many as 1 in 4 people with diabetes will develop a foot ulcer in their lifetime. These ulcers can become infected, cause disability, and potentially lead to amputation. More than 60% of non-traumatic lower limb amputations occur in people with diabetes -- approximately 82,000 in 2002 alone.
Charcot foot occurs in diabetic patients from joint degeneration that causes the foot to collapse, widen and become deformed. Diabetic patients progressing to Charcot deformity have lost most of the sensation in the foot, are unable to feel pain, and lose the ability to sense the position of the ankle joint. Muscles fail to support the joint properly and the foot becomes unstable. SBi's RingFIX(tm) Circular Fixation System stabilizes the Charcot foot and allows for proper alignment and recovery.
Patients in need of post traumatic reconstruction, congenital deformity correction, limb salvage or limb-lengthening have all been successfully treated by surgeons utilizing the SBi RingFIX(tm) system. According to Dr. Gary Jolly, recent past President of the American College of Foot and Ankle Surgeons (ACFAS), "SBi's RingFIX(tm) system is based upon the time tested external fixation gold standard of Ilizarov's method. Because the RingFIX(tm) system has been designed from the ground up to meet the specific requirements of lower limb surgeons, I find it far more user friendly in the operating room than other systems which have not been designed with this level of anatomic focus."
Anthony G. Viscogliosi, Founder, Chairman and CEO of Small Bone Innovations, Inc., remarked on SBi's RingFIX(tm) system, saying, "The SBi RingFIX(tm) Circular Fixation System highlights SBi's innovative lower limb products, designed in union with -- and specifically for -- small bone and joint surgeons. The new addition of Half Pins to a technology with a long and successful clinical history, like the RingFIX(tm) system, will only add to its ability to address the diseases and injuries of the lower limbs and allow patients to live better lives."
Viscogliosi added, "2006 was an extremely successful year for SBi as we took major steps to remain the industry leader in the small bone and joint market, specifically in the upper limbs -- finger to shoulder. The lower limbs -- toe to below the knee -- will be our top priority for 2007 as we continue to strive to serve the unmet clinical needs of small bone and joint surgeons and their patients."
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 and joint science. By integrating established companies and professionals in the field, SBi today offers a broad, clinically proven portfolio of innovation, products, technologies and education to treat trauma and disease in small bones and joints.
In establishing SBi, VB acquired several prominent U.S., Canadian and European orthopedic device companies and product technology licenses focused on small bone and joint treatment, including arthroplasty, internal and external fixation, trauma, and tissue technology.
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.
Medical Device & Diagnostic Industry Magazine named SBi to their list of "50 Companies to Watch" in 2006, noting, "Small Bone Innovations is going against the grain in its determination to become a market leader in the small bone and joint device sector."
For more information on SBi, please visit: www.totalsmallbone.com
The Small Bone Innovations, Inc. logo is available at http://www.primezone.com/newsroom/prs/?pkgid=3091
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 merchant banking, venture capital and private equity 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 40 years 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.