By Elizabeth Hofheinz, MEd, MPH
February 12, 2009
Make more space for SBi…the company is announcing the consolidation of five separate agreements into a single new agreement on worldwide license, supply, and distribution of Artelon products with Artimplant AB of Vastra Frolunda, Sweden (‘Artimplant’).
The new agreement covers the five existing technologies and two applications in development of the Artelon spacer portfolio designed to treat arthritis within small bone and joints. SBi will no longer own exclusive rights to market and sell spacer products already cleared by the U.S. FDA and certain other products not yet introduced in the U.S. market. In return, Artimplant will fund and provide increased clinical documentation on the performance of Artelon spacers, including patient studies. Artimplant will also receive a higher share of margins attributable to SBi sales of Artelon spacers.
Since 2005, approximately 10,000 implants have been performed—primarily in the U.S., with a better than 98% success rate and less than 1% documented explants. SBi first licensed the Artelon technology in 2004 and began marketing applications in the US in 2005 with the Artelon CMC-I (carpo-metacarpal) spacer to treat early to mid-stage osteo-arthritis (OA) in the base of the thumb.
The new agreement consolidating the five separate agreements is retroactive to January 1, 2009 and relates to the Artelon CMC-I Spacer, Artelon CMC Spacer Arthro, and Artelon STT Spacer, marketed worldwide and the Artelon DRU Spacer and Artelon MTP Spacer marketed outside the U.S.
An agreement reached in December 2007 between the two companies giving SBi exclusive rights to as yet undeveloped Artelon products for treating arthritis in the hands and wrist domain is unaffected by the new agreement.
In the news release, Anthony G. Viscogliosi, Chairman & CEO of SBi, said: “We are delighted to have consolidated our agreements to create greater synergies between SBi’s marketing and distribution strength and Artimplant’s research, development and manufacturing skills. The new agreement provides increased incentives for both our companies to continue to build the Artelon brand that has already contributed so successfully to the development of our upper limb portfolio in the U.S.”
He added that the new agreement will “enable SBi to focus its resources on expanding market acceptance for the Artelon technology to all the joints and bones in and around the thumb, fingers, hand and wrist, as well as a lower limb application being developed in Europe. As a resurfacing material, Artelon implants are minimally invasive, tissue sparing, and bone preserving as an early-stage treatment for osteoarthritis in the base of the thumb.”
The company has trained more than 1,200 hand surgeons and has over 850 surgeon users of Artelon spacers. The company estimates that U.S. surgeons perform up to 40,000 LRTI and fusion procedures annually on arthritic thumbs.
Viscogliosi told OTW, “Artimplant is currently conducting a long term study comparing Artelon with the LRTI (ligament reconstruction-tendon interposition) procedure among European patients. To date, the 3 and 5-year studies show improved thumb function, greater grip strength and stability in the CMC joint.”
Also commenting to OTW was Alejandro Badia, M.D. of the Badia Hand-to-Shoulder Center in Doral, Florida. Dr. Badia, a member of SBi’s Upper Limb Educational Committee, stated, “I have probably implanted Artelon spacers as frequently as anyone in the U.S. over the past three years or so. In treating OA in the CMC joint this versatile, biodegradable material is proving to be an efficient alternative to the LRTI procedure—especially as I can implant it arthroscopically—making it even less invasive. Also, I have yet to see any foreign body reaction to Artelon while it acts as a scaffold for the in-growth of a new pseudo-joint.”
