Healthcare Industry News:  osteoarthritis 

Devices Orthopaedic FDA

 News Release - June 19, 2007

Small Bone Innovations Adds Artelon(R) CMC Spacer Arthro to Thumb Osteo- Arthritis Implant Line

U.S. Food and Drug Administration grants clearance for marketing

NEW YORK, June 19 (HSMN NewsFeed) -- 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® CMC Spacer Arthro has been cleared by the FDA for marketing in the U.S. This product is an extension of SBi's line of carpal metacarpal (CMC) spacers to treat osteo-arthritis (OA) in the base of the thumb.

The Artelon® CMC Spacer Arthro was designed with the guidance and assistance of surgeons to allow minimally invasive, arthroscopic implantation in the joint between the first metacarpal and the trapezium. By avoiding violation of the joint capsule, the procedure may offer significant advantages to surgeons and their patients such as maintenance of joint stability, faster recovery and less pain.

Dr. Alejandro Badia, of the Miami Hand Center, said "The most convincing argument for using the Artelon spacer in a more minimally invasive, arthroscopic approach may be the rapid recovery and return to normal activities. This could have a profound economic impact as patients may quickly return to near normal function."

Dr. Randall W. Culp, Associate Professor of Orthopedic, Hand and Microsurgery, Thomas Jefferson University, Philadelphia, said: "Arthroscopic implantation of an Artelon spacer is a good option for younger, more active, people who may be reluctant to undergo invasive surgery for a condition that is increasingly common among this group."

SBi's Chairman and CEO, Anthony G. Viscogliosi, said: "This technology offers a superior solution to a widespread problem. This adaptation for minimally invasive, arthroscopic implantation reflects our philosophy of first serving patient needs while advancing surgeon education and training in the continuum of care for OA at the base of the thumb.

"By working closely with surgeons, we are committed to produce more advanced, keyhole-type surgical solutions, such as the Artelon® CMC Spacer Arthro, that are tissue-sparing, function-restoring and motion-preserving, to allow faster and more normal restoration of patients' quality-of-life," he added.

Since the introduction of the Artelon® Spacer CMC-I, in 2005, and the addition last year of the Artelon® CMC Spacer LG, this degradable technology has offered a conservative surgical option for patients suffering from early to mid-stage OA in the base of the thumb.

According to Mr. Viscogliosi, these spacers have previously been implanted, using an open, surgical incision, in more than 3,000 patients in the U.S. and Europe.

"Each of the three Artelon spacers: CMC-I, CMC LG (a larger version of CMC-I) and CMC Arthro permit therapy earlier in disease progression, and eliminate or minimize the sacrifice of healthy tissue in other CMC-I joint OA procedures that commonly include removal of the trapezium and harvesting tendon from the forearm," Mr. Viscogliosi noted.

For details of all Artelon products marketed by SBi visit: http://www.totalsmallbone.com/products/artelon.html

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 140 employees at facilities in New York, NY, Morrisville, PA and Minneapolis, MN.

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® 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: 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 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 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

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® 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 a public company, listed on the Stockholm Stock Exchange, O-list.

For additional information, please visit: www.artimplant.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.


Source: Small Bone Innovations

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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