U.S. Food and Drug Administration clears new implant for marketing
NEW YORK, Sept. 21 /PRNewswire/ -- Small Bone Innovations, Inc. (SBi), a single-source provider of products, technology and education for the small bone and joint sector of the orthopedic industry, announced that its Artelon(R) STT Spacer has been cleared by the FDA for marketing in the US.
This product extends SBi's line of surgically implanted, degradable spacers to four applications with two others planned for future introduction. SBi introduced and began marketing this unique technology in the US in 2005 with the Arteon(R) CMC-I spacer for early to mid-stage osteo-arthritis (OA) in the base of the thumb.
The Artelon STT Spacer is implanted in the scapho-trapezio-trapezoidial (STT) joint between the scaphoid and trapezial-trapezioid bones near the base of the thumb.
*Dr. James Nunley, Chairman of the Orthopedics Department, Duke University, NC, said: "I am delighted to see FDA clearance of the Artelon STT spacer and, if it proves to be as good as the CMC-I spacer, it will be a tremendous benefit for patients likely to be presenting with a more advanced stage of OA in the base of the thumb."
*Dr. Amit Gupta, Assistant Clinical Professor in the Department of Orthopedics at the University of Louisville, KY, added: "Artelon is a major advance in the treatment of small joint arthritis by providing an inert interpositioning material between joint surfaces that eventually degrades."
The Artelon STT Spacer is similar in size to the Artelon CMC Spacer LG, except that it has a 'single-wing' design (an L-shape vs. a T-shape), of woven, degradable Artelon fibers. The spacer is designed to preserve the STT joint and to help restore joint function while minimizing the need to sacrifice healthy bone and tissue.
Anthony G. Viscogliosi, Chairman & CEO of SBi, said: "The base of the thumb is one of the joints most commonly affected by osteoarthritis. The STT joint is usually affected at a later stage in the progression of the disease than is the more commonly diagnosed carpal-metacarpal (CMC-I) joint."
The addition of the Artelon STT Spacer expands SBi's coverage in the treatment algorithm and enables surgeons to offer a complementary range of spacers for every stage in the continuum of this debilitating disease.
Mr. Viscogliosi noted that widespread use of hand-held devices is increasingly a cause of repetitive stress conditions in the thumb leading to earlier onset of arthritis and prompting more surgical procedures such as the use of Artelon spacers.
"As with other Artelon spacers, of which more than 3,500 have been implanted since 2004, benefits may include restoring joint stability, faster recovery and post-operative elimination of pain," he added.
Prior to the introduction of the Artelon Spacer, more aggressive procedures were and continue to be used as an initial surgical option. These procedures often involve removal of the trapezoidium bone and replacing it with tissue harvested from the forearm (known as an LRTI procedure) or complete fusion of the joint.
SBi estimates that more than 40,000 of these procedures are performed on arthritic thumbs annually and that the number could rise to 55,000 by 2010.
Mr. Viscogliosi added: "What these figures do not reflect is that many more patients elect not to seek surgery of any type and may rely on a combination of medication and bracing, but with Artelon technology now being offered by several hundred hand surgeons, these patients now have access to a much less aggressive form of treatment."
Artelon Spacers now offer a new, less invasive, surgical option that spares healthy bone and tissue. The Artelon(R) CMC Spacer Arthro, cleared for marketing by the FDA earlier this year, permits minimally invasive arthroscopic implantation in patients at the earliest surgical stages of the condition.
The Artelon STT Spacer introduction stems from SBi's world wide marketing and licensing agreements with Artimplant, AB, of Sweden. The Artelon STT Spacer and the recently introduced Artelon CMC Spacer Arthro, for minimally invasive surgery, are the latest in a line of six products either already in the market or under development. Two more spacer products are planned for future introduction in the US: the Artelon(R) MTP and Artelon(R) DRUJ have received European CE marks but are not yet cleared for sale in the US.
For more details on Artelon products marketed by SBi visit: http://www.totalsmallbone.com/products/artelon.html
* Dr. Nunley has been compensated in the past by SBI for speaking engagements relating to medical education and marketing and may in the future be similarly compensated by SBI. Dr. Gupta is a counterparty to a product development/royalty agreement with SBI.
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 & joint science. By integrating established companies and professionals in the field, SBi can offer 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 and Bourg-en-Bresse, France.
SBi closed on the sale of $42.2 million of its securities in December 2005. At the time, 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, recognizing SBi 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(R) CMC-I Spacer, developed for patients with osteoarthritis at the base of the thumb, 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 its 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 & joint device sector."
For more information on SBi, please visit: http://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 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 nearly half a century of experience analyzing and investing in the musculoskeletal/orthopedics sector, directing 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 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: http://www.vbllc.com
About Artimplant AB
Artimplant is a biomaterials company, based in Vastra Frolunda, Sweden, and focused on solutions to problems in orthopedic, odontological and reconstructive surgery. The Company is engaged in the development, production and marketing of degradable implants designed to restore active lifestyles and improve quality of life.
The proprietary Artelon(R) technology, a long-term degradable biomaterial, offers new solutions to unmet clinical needs and opens new markets. Artimplant's business model is that of licensing its products and technology to global partners. The Company currently has six licensing agreements and one distribution agreement with three global partners. Artimplant is listed on the Stockholm Stock Exchange, O-list.
Artelon(R) is a registered trademark of Artimplant AB.
For additional information, please visit: http://www.artimplant.com
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.
|SOURCE Small Bone Innovations, Inc.|
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